Page 1 of 2 12 LastLast
Results 1 to 30 of 47
Like Tree1Likes
Neurontin
  1. #1
    cyndi is offline New Member
    Join Date
    Apr 2004
    Location
    .
    Posts
    1

    Default Neurontin

    Neurontin
    Generic Name: gabapentin

    What is Neurontin (gabapentin)?
    Gabapentin affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. The exact way that it works is unknown.

    You will find information on Neurontin at Drugs.com

    Consumer Information
    http://www.drugs.com/neurontin.html

    Professional Information
    http://www.drugs.com/pro/neurontin.html
    Neurontin (gabapentin) capsules, tablets and oral solution are supplied as follows:
    100 mg capsules; 300 mg capsules; 400 mg capsules; 600 mg tablets; 800 mg tablets; 250 mg/5 mL oral solution.

    Images of these preparations are available on this page.
    http://www.drugs.com/neurontin-images.html

    Additional Resources:

    Seizures
    http://www.drugs.com/CG/SEIZURES.html
    Last edited by ddcmod; 07-29-2008 at 12:29 AM.

  2. #2
    CDenton is offline New Member
    Join Date
    Apr 2004
    Location
    USA.
    Posts
    8

    Default

    actually it will decrease your appetite, and yes it will lessen the feeling or sensation during sex. its a drug that is used to treat illnesses like MS and degenerative spine disease. it works to block pain receptors and nerve ending in the brain and throughout the body.

    -CDenton RN-IV

  3. #3
    ivebeenhurtin is offline New Member
    Join Date
    Apr 2004
    Location
    USA.
    Posts
    4

    Default

    I read online that Neurotin is also used to treat Fibromyalgia as well? Is this true? Also why do so many medications have sexual side effects? I suffer from Chronic Migraines, Chronic Refractive Headaches, Fibromyalgia, Degenerative Disk Disease and Stenosis of L4-L5. My husband doesn't understand why my sexual responce isn't the same any more and blame himself, even though I have showed him the side effects of my medications. [?]What can I do to help this proglemm or make my husband understand that it is not Him???

    [?]Another questiion is...Is all my coditions possible related to just one? Does anybody else here have a combination of these conditions???

    Thanks for any help u can give,
    I be hurting![?]

    Lord please help me to get through my every day. If there is no help than please jus take me away!

  4. #4
    Jasonc is offline New Member
    Join Date
    May 2004
    Location
    .
    Posts
    4

    Default

    Hey, don't feel bad I have to take 800mg of neurontin 4 times!!!!!a day. I am getting fat and yes I can't get it up!LOL I am going to stop taking it when I get my new medication in, Avenza. Neurontin Accually is a deturrent medication to keep you off the heavy stuff. I am a chronic pain patient and I know these doctors tricks. If you want to know something also neurontin is very bad on the liver worse than tylonol or really any pain drug. I guess they want you to die before you feel tottaly better. If you take this make your doctor give you bi- monthly blood test to see if there is an increase in you liver (enzimes)?. I don't know how to spell that.LOL! I am terrible at spelling. FYI- I know people are worried about getting addicted but think Is this pain going away? If not you are not going to turn into a shoot up drug addict. That is what the government wants to promote to make you not want to take it. I have been taking narks for over six years and I haven't robbed anyone yet! That is a miss conception. Most people in real pain don't hurt anybody we are just happy to live.
    l5pine likes this.

  5. #5
    JodyC is offline New Member
    Join Date
    May 2004
    Location
    Canada.
    Posts
    2

    Default

    After being prescribed Neurontin my wife experienced greatly increased libidio, as well as, psychotic mania, mood swings, aggression, suicidal ideation, and had three attempted suicides. Not the nicest drug around. The prescribing psychiatrist refused to acknowledge that here bizarre symptoms were related to Neurontin, but of course, he was being funded by Pfizer.

  6. #6
    Ter567SAB is offline New Member
    Join Date
    May 2004
    Location
    USA.
    Posts
    1

    Default


    This is in response to "Ivebeenhurtin" If I did not know any better I would swear that your post was something I'd posted. I too suffer from fibromyalgia and degenerative disc disease and have been on multiple meds including neurontin for several years. I've undergone 2 back surgeries, a gastric bypass surgery, & hernia repair. Yes, the sex drive is caput! Please let your husband know that it is NOT his problem that the problem is a combination of the meds themselves and the your pain. I've learned through my own experience that when your back is hurting that you will do just about anything to get relief and that in combination with the pain of the fibromyalgia, sex is the LAST thing I'm interested in. If it helps, show this post to him. Hope you get some relief soon.

  7. #7
    bpyles is offline New Member
    Join Date
    May 2004
    Location
    United Arab Emirates.
    Posts
    1

    Default

    I have to get use to posting here. I posted wrong at first.
    I have severe Neuropathy and the Neurologist started by prescribing 400mg of Neurotin 3 times a day, increasing it to 800mg 3 times a day and then 1200mg 3 times a day. We didn't know the side effects but I was loosing my memory and alertness. The doctors just told me to let my wife drive because I wasn't alert to traffic lights or tail lights. Then I noticed I was having a time breathing and they put me on oxygen without finding the cause. My wife noticed my speach was slured. By the time I got a doctors appointment I was really bad and my wife and cried and told him I was dieing more ever day. He asked why I was talking with a thick toung and she said you think he is bad, He is good now. They hopizalized me and took away all medications, ran tests and gradually put me back on my medications except they prescribed 400mg of Neurotin. I improved considerable, but had neuropathy pain again. Now they are trying to use LOBITAL. Again, you have to be careful with it. Both are approved by FDA for Epilopsy. However, my neurologist said that 90% of the Neurotin is used for other reasons.
    Bill Pyles, wpyles@cfl.rr.com

    Bill Pyles

  8. #8
    Larson is offline New Member
    Join Date
    Jun 2004
    Location
    .
    Posts
    1

    Default

    I was prescribed neurontin for fibromyalgia symptoms. I had the side effects of raised blood pressure, swelling, headaches, and drying of my eyes. And to be honest, since my fibro diagnosis, almost everything they have tried me on has put weight on - without changes in eating habits. So I decided it wasn't worth it.Because of the side effects, I didn't even give it a long enough chance to see if helped the restless legs (and body) or my inability to sleep. I guess I was scared that I was doing more harm than good.
    Larson

  9. #9
    curly44 is offline New Member
    Join Date
    Jun 2004
    Location
    USA.
    Posts
    1

    Default

    I am a chronic migraine sufferer and I too am on neurontin. I take 1500 mg. twice a day. My neurologist likes this drug because it does not go through the liver. I have gained a few pounds with it, but it is better than the horrible headaches I was getting. I take imitrex and maxalt-mlt and have success with them.
    Linda

    Linda

  10. #10
    JLM
    JLM is offline New Member
    Join Date
    Aug 2004
    Location
    .
    Posts
    4

    Default

    I don't see why anyone would want to take Neurontin at all.

    http://www.nytimes.com/2002/10/29/bu...t&position=top

    quoteocuments Show Effort to Promote Unproven Drug
    By MELODY PETERSEN

    Marketing executives at Warner-Lambert urged their superiors to let them promote the epilepsy drug Neurontin for an unapproved use rather than perform the clinical studies needed to prove the medicine was safe for such patients, according to a corporate memorandum unsealed on Friday in federal court.

    The six-page memorandum was filed in Federal District Court in Boston by Thomas M. Greene, a lawyer for a whistle-blower who accused Warner-Lambert of promoting Neurontin to doctors in the late 1990's for more than a dozen conditions it was never approved to treat.

    In the memo, dated May 5, 1997, the marketing executives propose that Neurontin be promoted to treat pain in diabetic patients by creating education classes for doctors and sponsoring a symposium with the American Diabetes Association.

    Mr. Greene also filed another memorandum with the court that details how Warner-Lambert tracked prescriptions written by doctors after they attended dinner meetings paid for by the drug company at which Neurontin was discussed. The memo, dated June 26, 1995, said that in the Northeast, doctors attending the dinners wrote 70 percent more prescriptions for Neurontin than doctors who did not attend.

    At issue in the case is tens of millions of dollars that taxpayers paid for Neurontin prescriptions written for Medicaid patients who had conditions the drug was not approved to treat.

    Pfizer, which acquired Warner-Lambert and its Parke-Davis division in 2000, says the lawsuit relates to activities that took place before the acquisition and that its employees do not promote drugs for unapproved uses. Pfizer has said that it is not aware of any credible evidence showing Warner-Lambert employees made false claims about the drug.

    Pfizer has been fighting to prevent the release of hundreds of similar documents, which it says are confidential information. This summer, Judge Patti B. Saris ordered Pfizer to go through the documents and release any that did not include information that would put it at a competitive disadvantage.

    Mr. Greene charged in a motion on Friday that Pfizer was selectively seeking to keep confidential the documents that were "the most damaging." To support his claim, he filed the two memos, which Pfizer had allowed to be released, along with other documents it had stamped confidential to show that all were similar. All the documents, he said, detailed how Warner-Lambert had marketed Neurontin.

    "These documents tell a consistent story of the defendants' marketing strategy," Mr. Greene wrote, "hatched at the highest levels of Parke-Davis, to brazenly market Neurontin off-label."

    Mr. Greene's client, Dr. David P. Franklin, worked for Warner-Lambert in 1996, and says that he resigned after finding that the company was involved in a nationwide marketing campaign that he thought was illegal and was endangering patients.

    Mr. Franklin says that company gave financial incentives to hundreds of doctors to prescribe Neurontin for unapproved uses ranging from bipolar disorder to a myriad of pain syndromes, by inviting them to dinners and weekend trips to resorts. He asserts that Warner-Lambert also paid doctors to speak about Neurontin and to prescribe Neurontin to patients who were enrolled in the company's clinical trials.

    The United States attorney's office in Boston is conducting criminal and civil investigations into the marketing of Neurontin. In addition, 47 states have joined to pursue their own criminal and civil investigations.

    Pfizer said in 2000 that more than 78 percent of Neurontin prescriptions were written for unapproved uses. This year, sales of the drug are expected to exceed $2 billion. Pfizer says it is cooperating with investigators and cannot comment in more detail due to the pending litigation.

    Under federal law, doctors can prescribe drugs in any way they believe will best help patients. But it is illegal for a drug maker to promote a medicine for conditions that are not approved by the Food and Drug Administration, which requires detailed clinical trials showing its safety and effectiveness.

    In the 1997 memo, Warner-Lambert executives recommended against doing studies needed to get Neurontin approved to treat diabetic patients because of the short time that they expected the company to be able to sell the drug exclusively. The executives expected the drug's patent to expire in 2000, which would allow companies to make low-priced generic versions.

    The executives recommended that Neurontin be promoted for the unapproved condition through educational courses.

    Kathleen McDermott, a former assistant United States attorney who works at the law firm of Blank Rome Comisky & McCauley, said that it is not always clear that a company has broken the law by promoting a drug for an unapproved use through continuing medical education.

    "There is a gray area of what is permissible," Ms. McDermott said.

    What is more troublesome, she said, is when drug companies give doctors gifts or financial incentives that could be viewed as financial rewards for prescribing a drug.

    "If these activities go beyond C.M.E. to big dinners and junkets, I would be concerned," Ms. McDermott said.

  11. #11
    JLM
    JLM is offline New Member
    Join Date
    Aug 2004
    Location
    .
    Posts
    4

    Default

    and.....

    http://www.legalnewswatch.com/news_351.html

    quote:Pfizer Settles Neurontin Off-Label Marketing Lawsuit for $427M
    Posted on May 13, 2004

    Pfizer Inc., the world's largest pharmaceutical company, has agreed to plead guilty and pay more than $430 million to settle all criminal charges and civil liabilities related to the illegal and fraudulent promotion of unapproved uses for its top selling epilepsy drug Neurontin by Warner-Lambert's Parke-Davis Division, the Justice Department said in a prepared statement issued on Thursday.

    "The Department of Justice is committed to rooting out and prosecuting health care fraud," said Associate Attorney General Robert McCallum. "The Department's commitment to effective health care fraud enforcement is driven by a mandate that wrongdoers be brought to justice, to deter conduct which threatens the safety and welfare of all Americans, and the need to protect the resources of the Medicare Trust Fund, state Medicaid programs, and other government health programs."


    Neurontin
    =======
    Neurontin was approved in 1993 for the treatment of partial seizures with and without secondary generalization in adults with epilepsy. In 2002, Pfizer received approval for Neurontin for treatment of post-herpetic neuralgia.

    Once approved, the drug may not be marketed or promoted for so-called "off-label" uses - any use not specified in an application and approved by the Food and Drug Administration.


    Off-Label Uses
    ==========
    However, Warner-Lambert's strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved, the Justice Department said. The company promoted Neurontin for the treatment of bipolar mental disorder, various pain disorders, Lou Gehrig's Disease, attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first-line monotherapy treatment for epilepsy (using Neurontin alone, rather than in addition to another drug).

    Warner-Lambert promoted Neurontin even when scientific studies had shown it was not effective, the Justice Department said. For Example, the company falsely promoted Neurontin as effective for treating bipolar disease, even when a scientific study demonstrated that a placebo worked as well or better than the drug.

    "This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision-making, thereby putting patients at risk," stated U.S. Attorney Michael Sullivan.


    Consequence of Illegal Marketing Scheme
    ============================
    As a consequence of the unlawful promotion scheme, patients who received the drug for unapproved and unproven uses had no assurance that their doctors were exercising their independent and fully-informed medical judgment, or whether the doctor was instead influenced by misleading statements made by, or inducements provided by, Warner-Lambert, the Justice Department said. Potential problems that can arise from off-label use without the benefit of careful FDA oversight include the occurrence of unforeseen adverse effects because the drug was not studied in the type of patient it is being used for off-label and the appropriate dosage and course of treatment have not been established.

    "The plea agreement and settlement announced today marks the end of an exemplary effort to use all of the appropriate anti-fraud weapons available to us in a concerted manner to send clear and unequivocal messages to the pharmaceutical industry," said Assistant Attorney General Peter D. Keisler. "To insure a just result, we in the Civil Division will vigilantly join our tools for fighting fraud on consumers with those available to remedy fraud on the federal health care programs."


    Illegal Marketing Tactics
    ================
    Warner-Lambert used a number of tactics to achieve its marketing goals, including encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors, the Justice Department said. The company's agents also made false or misleading statements to health care professionals regarding Neurontin's effectiveness. The company also utilized "Medical Liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.

    Warner-Lambert paid doctors to attend so-called "consultants meetings" in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made, the Justice Department said. These events included lavish weekends and trips to Florida, the 1996 Atlanta Olympics and Hawaii. There was little or no significant consulting provided by the physicians.

    The pharmaceutical company implemented numerous teleconferences in which physicians were recruited by sales representatives to call into a pre-arranged number where they would listen to a doctor or a Warner-Lambert employee speak about an off-label use of Neurontin.

    The company also sponsored purportedly "independent medical education" events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants.

    Warner-Lambert paid physicians to allow a sales representative to accompany the physician while he or she saw patients, with the representative offering advice regarding the patient's treatment, which was biased towards the use of Neurontin, the Justice Department said.

    These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan. At the same time, Warner-Lambert decided not to seek FDA approval for any of the new uses because it was concerned that approval for any of the non-epilepsy uses would allow generic competitors of Neurontin, which was expected to go off-patent soon, to compete with a "son of Neurontin" drug that Warner-Lambert hoped to have approved by the FDA for both epilepsy and non-epilepsy uses, the Justice Department said.


    Building a Blockbuster Drug
    ===================
    Neurontin was launched into the marketplace in February of 1994; from mid-1995 to at least 2001, the growth of off-label sales was tremendous. While not all of these sales were the consequence of Warner-Lambert's illegal marketing, the marketing scheme was very successful in increasing Neurontin prescriptions for unapproved uses, the Justice Department said.

    The state Medicaid programs were harmed by Warner-Lambert's aggressive promotion for off-label uses in numerous ways. The conduct caused doctors to write prescriptions for Medicaid patients when those medications were not eligible for Medicaid reimbursement in that the prescriptions were fraudulently obtained through false statements to doctors and by payment of illegal kickbacks, including so called "consulting fees" and trips for physicians.


    The Whistle-blower
    =============
    The investigation was commenced in the District of Massachusetts when a former medical liaison for Warner-Lambert, Dr. David Franklin, filed a suit on behalf of the U.S. government. Private individuals like Dr. Franklin are allowed to file whistleblower suits under the federal False Claims Act to bring the United States information about wrongdoing. If the United States is successful in resolving or litigating the whistleblower's claims, the whistleblower may share in part of the recovery. As a part of today's resolution, Dr. Franklin will receive approximately $24.64 million of the civil recovery.


    Under the Agreement
    ===============
    (a) Warner-Lambert has agreed to plead guilty to two counts of violating the Food, Drug & Cosmetic Act with regard to its misbranding of Neurontin by failing to provide adequate directions for use and by introduction into interstate commerce of an unapproved new drug. Warner-Lambert has, as punishment for these offenses, agreed to pay a $240 million criminal fine, the second largest criminal fine ever imposed in a health care fraud prosecution. The Plea Agreement between the United States and Warner-Lambert specifically states that Warner-Lambert's criminal conduct caused losses of $150 million and that the violations are felonies as a consequence of Warner-Lambert's prior Food, Drug & Cosmetic Act conviction.

    (b) Warner-Lambert has agreed to settle its federal civil False Claims Act liabilities and to pay the United States $83.6 million, plus interest, in civil damages for losses suffered by the federal portion of the Medicaid program as a result of Warner-Lambert's fraudulent drug promotion and marketing misconduct.

    (c) Warner-Lambert has agreed to settle its civil liabilities to the fifty states and the District of Columbia in an amount of $68.4 million, plus interest, for losses the state Medicaid programs suffered as a result of Warner-Lambert's fraudulent drug promotion and marketing misconduct.

    (d) Warner-Lambert has agreed to settle its civil liabilities to the fifty states and the District of Columbia in an amount of $38 million, plus interest, for harm caused to consumers and to fund a remediation program to address the effects of Warner-Lambert's improper marketing scheme. This part of the global settlement agreement was negotiated by the Consumer Protection divisions of the fifty State Attorneys General.

    (e) Pfizer Inc, Warner-Lambert's parent company, has agreed to comply with the terms of a corporate compliance program, which will ensure that the changes Pfizer Inc made after acquiring Warner-Lambert in June 2000, are effective in training and supervising its marketing and sales staff, and ensures that any future off-label marketing conduct is detected and corrected on a timely basis. In addition, Warner-Lambert agreed to an injunction by a state court against continuing the improper conduct that was the subject of the States' Consumer Protection Divisions investigation.


    Pfizer Inc, the owner of Warner-Lambert since June of 2000, has also agreed to institute a compliance program. The charged conduct occurred prior to the acquisition.

  12. #12
    JLM
    JLM is offline New Member
    Join Date
    Aug 2004
    Location
    .
    Posts
    4

    Default

    This article was originally in Boston Globe. Look at what the head of psychopharmacologist at Harvard had to say. Dr. Bodkin...



    Use of drug soars despite controversy

    Neurontin maker faces probes into marketing

    By Liz Kowalczyk, Globe Staff, 11/25/2002

    When federal investigators flew into Massachusetts looking for doctors who heavily prescribed Neurontin, an anticonvulsant drug whose sales were soaring, they quickly zeroed in on Dr. David Osser, a psychiatrist and one of the top 10 Neurontin prescribers at VA Medical Center in Brockton.


    The investigators wanted to know whether the people who sell the drug for the manufacturer had pressured him. He assured them that they hadn't and that he was prescribing lots of Neurontin because doctors at conferences and in medical journals were praising the drug and he thought it might help patients suffering from bipolar disease.

    Osser's views have changed. After that encounter three years ago, he has cut back on prescribing the drug, also known by its generic name, gabapentin.

    But Osser, who now sits on a state committee investigating the widespread use of the drug in the Massachusetts Medicaid program, said many physicians have not. Neurontin use remains profuse, even as doubts about its effectiveness for bipolar patients has grown. The state will soon warn 5,000 physicians to cut down on ''inappropriate'' use.

    ''People call it Vitamin G,'' he said. ''It's everywhere.''

    The aggressive marketing of Neurontin has made its manufacturer, Parke-Davis, now owned by Pfizer Inc., a lot of money, but also made it the subject of a federal investigation, a multistate probe, and a whistle-blower lawsuit filed in Boston.

    But the skyrocketing use of the drug - doctors wrote 14 million prescriptions for it last year - even as doubts were growing about its effectiveness for some uses also makes the Neurontin story a case study in why prescription drug costs have overwhelmed state Medicaid programs. And it offers a window into the best intentions and the excesses of the American medical system.

    When Osser says Neurontin is everywhere, he is exaggerating, but only a little. Even though the Food and Drug Administration has approved it only as an add-on drug for epilepsy and for shingles pain, more than 80 percent of prescriptions for it are written for bipolar illness, anxiety, posttraumatic stress disorder, all kinds of pain, insomnia, restless leg syndrome, hot flashes, migraines, and tension headaches.

    ''Neurontin is a useful drug, especially in painful conditions, but it's being used for everything and everybody,'' said Dr. Sami Harik, a member of the board of the American Academy of Neurology and head of neurology at the University of Arkansas College of Medicine.

    ''Migraines, tension headaches, low back pain, a vast host of psychiatric diseases, and I haven't seen evidence yet it's effective in those conditions,'' Harik said. ''I hardly see a patient who's not on Neurontin. And it's expensive.''

    Those costs have hit state Medicaid programs and private insurers hard. Ohio Medicaid spent $24 million on the drug this year, twice what it spent in 2000. Florida's expenditures tripled to $15 million between 1998 and 2001. And in Massachusetts, which spent $25 million on Neurontin this year compared with $3 million just three years ago, Dr. Ken Duckworth, deputy commissioner at the state Department of Mental Health, said Neurontin has become ''a cause celebre.''

    Marketing, physicians
    help sales take off

    How did this happen? One answer is that the drug manufacturer worked hard to make the drug take off. The whistle-blower, former employee David Franklin, and investigators allege that Parke-Davis illegally marketed Neurontin for unapproved and unproven uses. And company documents released by Franklin's lawyer, Thomas Greene of Boston, suggested last week that the company may have continued to do so even after finding out that the FDA was investigating its marketing tactics, raising questions about the agency's ability to monitor increasingly sophisticated and wide-ranging marketing practices. Pfizer, which is in settlement discussions, will not comment on the court case, and the FDA would not discuss its probe.

    Meanwhile, company records show there were concerns within Parke-Davis about perceptions that their drug was ineffective. And executives appeared split over how aggressively to market the drug. Over the apparent objections of some executives, one document shows, Parke-Davis held a training weekend for physicians in Palm Beach to speak about Neurontin as a stand-alone epilepsy treatment - one month after the FDA rejected the company's application for this purpose.

    But it wasn't marketing alone that pushed Neurontin to become number four in sales among Pfizer's many drugs. It was also physicians, who, particularly in psychiatry, have a long history of prescribing drugs ''off-label'' if anecdotal reports indicate patients might benefit.

    Doctors say Neurontin, which has few serious side effects, appeared at a time when patients with bipolar and anxiety disorders were desperate for new nonaddictive medications that didn't cause them to put on weight. Antiepileptic drugs traditionally have worked for a variety of disorders, from mental illness to pain, so it made sense for doctors to try Neurontin for these conditions.

    This freedom to prescribe drugs for unapproved uses is a cornerstone of medicine, physicians said, a form of experimentation that has led to many important discoveries. And in the end, that could be true in the case of Neurontin, where evidence is building that the drug helps ease some patients' excruciating neuropathic pain, physicians said. Henry Esterman of West Roxbury, who took it for nerve pain in his lower back related to diabetes, said he was ''very grateful for it. The pain was unbearable, and nothing else touched it.''

    And even for psychiatric disorders, doctors contend Neurontin works for some patients and can boost the effectiveness of other medications. It seems to help some anxious people sleep and is given to patients with anxiety disorders who complain about the side effects of antidepressants or who are substance abusers and can't take the addictive benzodiazepines. A new study shows effectiveness in treating social phobia.

    But Dr. Jefferson Prince, director of child psychiatry at North Shore Medical Center, said another factor was at work in Neurontin's success: Its relative innocuousness, compared with some other drugs. ''It was socially acceptable. If you're a patient thinking about Haldol and lithium, you're thinking `Oh my God, those are serious drugs.' But Vitamin G, that's something neurologists use ... That's why it took off.''

    Marketing strategies
    pursue all avenues

    Still, the push from the manufacturer remained a major factor. Soon after the FDA approved Neurontin in January 1994, Parke-Davis executives realized the epilepsy market alone would not capitalize on the tremendous business opportunities they saw for the drug. In one of hundreds of company documents released in the court case, Parke-Davis hired the New York advertising firm Cline, Davis & Mann in 1996 to develop ''Neurontin War Games,'' an assessment by a group of executives of every anticonvulsant drug.

    When they turned to their own drug, Neurontin, the executives were honest: ''Excellent safety profile,'' they wrote, but under weaknesses they listed ''small prescriber base,'' ''slow growth of the epilepsy market,'' and ''perceived lack of efficacy.'' Under opportunities to be explored, they pointed to neuropathic pain, migraines, monotherapy, bipolar disorders, and psychiatrists.

    Over the next several years, the documents suggest, Parke-Davis made aggressive plans to pursue these new markets. The company developed promotional strategies that touched every corner of medicine.

    David Waterbury, assistant attorney general in Washington state who is leading the 47-state investigation into whether Parke-Davis's marketing led Medicaid programs to pay for Neurontin unnecessarily, said he is concerned Parke-Davis aggressively ''put out misinformation into the general medical culture.''

    Beginning in August 1994, the company recruited hundreds of physicians, particularly those who prescribed competing drugs to patients, to participate in teleconferences about Neurontin. The company also targeted continuing medical education courses for doctors and hired Medical Education Systems in Philadelphia in 1997 to draft a series of 12 scientific articles on anticonvulsant therapy, including expanded uses, monotherapy, bipolar disorder, and migraine.

    Medical Education Systems contacted faculty members considered authorities in their field and chosen by Parke-Davis, and paid them $1,000 each to author the articles. The Globe could not determine whether all 12 articles were published, but some were, including articles on gabapentin's role in the treatment of pain, mania, and mood and anxiety disorders. At least three of the articles gave no hint to readers that Parke-Davis had paid for them, and even had a hand in reviewing drafts - the sort of disclosure many scholarly journals routinely require.

    On June 20, 1997, Medical Education Systems senior editor Mary Anderson wrote to Allen Crook, Parke-Davis product segment manager, about one of these articles, a discussion of the role of gabapentin and another drug in the treatment of mood and anxiety disorders. ''Please make any comments directly on the manuscript and return it to me,'' she directed.

    Dr. Mark Pollack, the psychiatrist at Massachusetts General Hospital who wrote the article published in CNS Spectrums in 1997, said he can't remember whether Medical Education Systems told him about Parke-Davis's role. ''It was my article and I wrote it,'' said Pollack, who is a consultant for Pfizer and other companies. ''It would not have gone out with my name on it if it wasn't true. The standards for disclosure are changing; now we're ask to list all of our relationships with industry.'' Dr. Andrew Stoll, director of the psychopharmacology research lab at McLean Hospital in Belmont, said he first heard of Neurontin in 1995 when a severely bipolar patient brought in an article.

    The drug didn't work for the patient, but Stoll began trying it with others. Soon he was working for Parke-Davis, speaking to other doctors about the drug's promise. He stopped doing so after two recent studies called into question Neurontin's usefulness for bipolar patients, and he no longer prescribes it as much, he said.

    One of his patients, Erica, a 22-year-old student, tried it soon after she was diagnosed with severe bipolar illness, characterized by rapid swings from mania to depression, three years ago. She didn't want to take lithium, which can cause massive weight gain and seizures, so she tried Neurontin. But the drug caused terrible mood swings and put her in the hospital for five days. Doctors said such a dramatic side effect is rare, but underscores why studies on large numbers of patients are necessary to determine a drug's impact. Erica, who did not want her last name published, said she's now resigned herself to using lithium - and has gained 50 pounds.

    ''Its share of the market, its sales, really exceed its efficacy,'' said Dr. Jerrold Rosenbaum, Mass. General's chief of psychiatry. ''The question is, was the company denying investigators access to negative data when they asked for it?''

    Still, most doctors say they don't believe the off-label use of Neurontin hurt patients, mostly because the drug is so mild.

    Dr. Alec Bodkin, chief of the clinical psychopharmacology research program at McLean, said Neurontin is still so widely used in psychiatry because ''it's the ideal placebo'' - a harmless medication on which patients improve because of the belief it is helpful.

    ''We have utterly underused the placebo in our branch of medicine, in all of medicine, and we should make the best use of that,'' Bodkin said. ''So, no, I don't think this is any kind of an outrage, unless the patients could have been taking something more effective instead.''

    Liz Kowalczyk can be reached at kowalczyk@globe.com.

    This story ran on page A1 of the Boston Globe on 11/25/2002.
    © Copyright 2002 Globe Newspaper Company.



  13. #13
    debbies2 is offline New Member
    Join Date
    Aug 2004
    Location
    USA.
    Posts
    1

    Default

    Cindy, My friend asked me to do some research on Neurotin as they stopped her abruptly from taking it.. Saying it wasen't helping her restless legs and are going to try topamax when she goes in for her monthly appointment.. She has been on neurotin for 4 years, She had great concern about stopping it perhaps with some withdrawals or side affects.. The Dr told her no... She stopped taking the drug about a week ago and has been sick, upset stomach, diaharea, and other symptoms...Her appointment isn't for another two weeks, What type of Dr would do this I have no idea..I told her I would get online and try to find out what I could for her, She suffers with mood swings and I think severe depression as well.
    If you can give me any information for her it would be greatly appreciated. Thank you so much, I am new at this and just signed up today to be able to get some advice.Thanks again to any and all who can possibly help.
    Debbie

    debbie krone

  14. #14
    CREATIVE is offline New Member
    Join Date
    Sep 2004
    Location
    .
    Posts
    1

    Default

    I HAVE BEEN ON NEURONTIN FOR JUST 2 DAYS NOW AND WAS VERY SURPRISED TO READ THE POSTINGS HERE ... THIS IS WHAT I HAVE EXPERIENCED SINCE MY FIRST DOSE ( OF ONLY 300 MG A DAY ! ) I TAKE IT AT NIGHT ... IT DOES NOT MAKE ME IMEDIATELY SLEEPY , I TOSS AND TURN FOR A WHILE , BUT I DO SLEEP WELL WITH IT ONCE I FALL ASLEEP , AND WAKE UP FEELING PUFFY UNDER THE EYES AND KINDA SWOLLEN , I FEEL "HIGH" , DROWSY FOR THE FIRST 20 MINS , IS VERY VERY HARD TO WAKE UP , BUT ONCE I GET GOING , STILL FEEL KINDA HIGH AND GET A "FLOATING " FEELING THAT I AM NOT SURE IF IM COMFORTABLE WITH YET , BUT IT HAS SEMED TO STOP THE PAIN FOR THE MOST PART OF THE FIBROMYALGIA THAT I HAVE SUFFERED WITH FOR 10 YRS OR SO . HOWEVER , I HAVE THE FEELING OF BLOOD RUSHING TO MY HEAD AT TIMES . MY EXPERIENCE HAS BEEN THAT IT SEEMS TO BE A VERY POWERFUL DRUG AND I CANT EVEN BEGIN TO UNDERSTAND HOW SOME OF YOU CAN TAKE 1200 - 1500 MG A DAY ??? I AM SENSITIVE TO CODEINE AND PAIN KILLERS , AND I WOULD THINK FROM THIS WAY THIS STUFF MAKES ME FEEL IT WOULD BE CATAGORIZED UNDER ADDICTIVE ? THE FIRST DAY I MIS UNDERSTOOD MY DOC AND TOOK 300 MG 2 TIMES A DAY AND FELT " REALLY REALLY WEIRD.
    IS ALL THIS UNUSUAL ? ANY RESPONSE IS APPRECIATED .
    PS , ALSO HAVE COME DOWN WITH A SINUS INFECTION ALL OF A SUDDEN , IS THIS A SIDE AFFECT ?

  15. #15
    painweaner is offline New Member
    Join Date
    Sep 2004
    Location
    .
    Posts
    1

    Default

    does anyone have info on neurontin and hair loss in women?

  16. #16
    Felicity is offline New Member
    Join Date
    Oct 2004
    Location
    .
    Posts
    7

    Default

    To Creative:
    When I first started taking Neurontin three years ago I remember the same feelings, I think it took about a week and a half maybe two to feel normal taking it. I now take 300mgs three times a day and I can't even tell. After reading this discussion I'm gonna have a serious talk with my doctor about it. I had no idea it was so dangerous. I also have fibromyalgia and it helps me tremendously with the pain. I'm at a loss here I don't know what else to take for the pain as I've tried just about everything. Does anyone have any suggestions?

  17. #17
    Beverly4 is offline New Member
    Join Date
    Oct 2004
    Location
    USA.
    Posts
    1

    Default



    Hi! My name is Beverly and I'm new here.

    I've been taking 100 milligrams of Neurotin every night for the past two months. My doctor prescribed it for nerve pain when he found out I had Shingles. During the past couple of weeks I became really nauseated so I called my Pharmacist and asked him if this drug could be causing it and he said it most definitely could so I stopped taking it. I've had Shingles for almost 3 months and both my pinkie and ring finger on my right had hurt really bad/I can't even bend them of straighten my ring finger out. Anyway I still have the nausea and I really need to take the Neurotin but I'm afraid it will make me feel even more nauseated than before.

    Has anyone on here ever taken Neurotin for Shingles and if so did you experience any side effects?

    All replies would be appreciated.

    Thank you.

    Beverly

  18. #18
    astraleilani is offline New Member
    Join Date
    Nov 2004
    Location
    USA.
    Posts
    3

    Default

    quote:Originally posted by ivebeenhurtin

    I read online that Neurotin is also used to treat Fibromyalgia as well? Is this true? Also why do so many medications have sexual side effects? I suffer from Chronic Migraines, Chronic Refractive Headaches, Fibromyalgia, Degenerative Disk Disease and Stenosis of L4-L5. My husband doesn't understand why my sexual responce isn't the same any more and blame himself, even though I have showed him the side effects of my medications. [?]What can I do to help this proglemm or make my husband understand that it is not Him???

    [?]Another questiion is...Is all my coditions possible related to just one? Does anybody else here have a combination of these conditions???

    Thanks for any help u can give,
    I be hurting![?]

    Lord please help me to get through my every day. If there is no help than please jus take me away!

    ---------------------------------------------------
    I also have:
    Fibromyalgia with constant, chronic pain,
    Spastic colon (or inflamatory bowel syndrome)with diharea(sp?),
    Manic depressive/bipolar (along with other mental health diagnosises)

    I take neurontin for my nerves and anxiety. (I didn't know that they also use it for pain, but it does make sense because I know other psychotropic drugs like Elavil can also relieve pain.)

    I have been told that alot of these problems and diseases go hand-in-hand. Although they don't know exactly what causes Fibro, they do say that it gets worse during stressful periods. I do notice that when I get more depressed, I hurt more. [V][|)] I also have problems with my spastic colon and suffer with the dihareah(sp?) even more.
    My mom had and one of my sisters currently has Degenerative Disc Disease. My other sister and I both have Fibromyalgia. All of us have mental health issues.

    I've been on Neurontin for 4 years, and started it because my anxiety got really bad after I had my son. I do experience the decrease in stimulation, however I attribute much of it to my c-section, as I felt decreased stimulation before I started neurontin/ Also, I found studies that were done with people who had surgeries done on the stomach that reported that when the stomach was cut, nerves sometimes were damaged that caused the decrease in stimulation. Four years after my c-section I [u]still</u> have no feeling right above, below and around the scar.
    I will tell you one thing that did help with the stimulation for me... I got my hood peirced (no, it [u]didn't</u>hurt that bad). My small ring rubs at the right spot during sex and I have recovered much of the sensation I have lost.
    As for speaking with your husband, search the internet for all the information you can... and sit down with him and talk it all over. Try speaking with more people about the problems... He may realize after hearing from more people that it's not him. At first, after my c-section, I had difficulty discussing my sexual problems with my husband... I found that speaking kinda bluntly and laying it [u]ALL</u> out worked best. I had to drop ALL my inhibitions about sex to work things out with him. There are still times that he takes things personally and blames himself for me not being stimulated.
    If you want to email me directly to speak bluntly about this, please do. As this is a public forum, I don't feel some terms and to-the-point discussion is appropriate.


    Astra Leilani

  19. #19
    astraleilani is offline New Member
    Join Date
    Nov 2004
    Location
    USA.
    Posts
    3

    Default

    quote:Originally posted by JodyC

    After being prescribed Neurontin my wife experienced greatly increased libidio, as well as, psychotic mania, mood swings, aggression, suicidal ideation, and had three attempted suicides. Not the nicest drug around. The prescribing psychiatrist refused to acknowledge that here bizarre symptoms were related to Neurontin, but of course, he was being funded by Pfizer.

    I have the mood swings to begin with (as I am manic depressive/bipolar). Because of stressful situations I was in, I started feeling the aggression and had [u]real bad</u> anger problems in the months after my son was born. The first thing they tried was Seraquel.. [u]BOY WAS THAT A DISASTER!!!</u> I [u]couldn't</u> be angry, I wasn't AWAKE long enough at a time to become angry. I took myself off of it and asked to try something else.
    Then they upped my neurontin, and the anger problems decreased. Also, I got changed from Tegretol to Trileptol, which gave me even more relief of my mood swings, depression, anxiety and anger problems.
    There could be other factors involved with the symptoms your wife was experiencing, and not just the neurontin...

    Someone else mentioned having to take blood tests to check your liver functions and enzymes.. After I got changed to the Trileptol, I haven't had to take a blood test. I now take Trileptol 600mg twice a day, Effexor 300mg twice a day, Neurontin 300mg twice a day and Trazadone 100mg at bedtime. This combination works for me, however I know that not all drugs work the same for everyone.

    I believe most people on neurontin are also on other psych meds, like me. We need to check to make sure which drugs are the ones that require blood tests. I know for sure that Tegretol and Lithium do effect your liver, the same way that taking too much tylenol does.


    Good luck finding the right combination.

    Astra Leilani

  20. #20
    astraleilani is offline New Member
    Join Date
    Nov 2004
    Location
    USA.
    Posts
    3

    Default

    quote:Originally posted by JLM

    This article was originally in Boston Globe. Look at what the head of psychopharmacologist at Harvard had to say. Dr. Bodkin...

    *****snip*****
    But it wasn't marketing alone that pushed Neurontin to become number four in sales among Pfizer's many drugs. It was also physicians, who, particularly in psychiatry, have a long history of prescribing drugs ''off-label'' if anecdotal reports indicate patients might benefit.
    Doctors say Neurontin, which has few serious side effects, appeared at a time when patients with bipolar and anxiety disorders were desperate for new nonaddictive medications that didn't cause them to put on weight. Antiepileptic drugs traditionally have worked for a variety of disorders, from mental illness to pain, so it made sense for doctors to try Neurontin for these conditions.
    This freedom to prescribe drugs for unapproved uses is a cornerstone of medicine, physicians said, a form of experimentation that has led to many important discoveries. And in the end, that could be true in the case of Neurontin, where evidence is building that the drug helps ease some patients' excruciating neuropathic pain, physicians said.
    Henry Esterman of West Roxbury, who took it for nerve pain in his lower back related to diabetes, said he was ''very grateful for it. The pain was unbearable, and nothing else touched it.''

    And even for psychiatric disorders, doctors contend Neurontin works for some patients and can boost the effectiveness of other medications. It seems to help some anxious people sleep and is given to patients with anxiety disorders who complain about the side effects of antidepressants or who are substance abusers and can't take the addictive benzodiazepines. A new study shows effectiveness in treating social phobia.
    Even the doctors admit it's a mix-and-match situation when it comes to mental health! I don't see what's wrong with trying drugs for different diagnosises. If a drug can potentially work for a different thing than what it is listed for, then the ONLY way to find out is to [u]TRY IT.</u>
    They have known for years that drugs made for seizure patients work for mental health problems such as manic-depression/bipolar disorder and anxiety. So, when a new drug comes out for epileptics, I can understand doctors automatically trying it for the other "off-label" uses.



    Astra Leilani

  21. #21
    Teekai is offline New Member
    Join Date
    Nov 2004
    Location
    .
    Posts
    1

    Default

    My Neurologist has prescribed Neurontin...however, the (nerve) pain that I get only happens (sporadically) anywhere from once a month; every 6 months...etc. I don't want to take this (Neurontin) daily since the last time I have had an this terrible pain in my leg has now been 5 months...
    I take a pill when I am scared to fall asleep..(only once it's has happened during the day...other times during the night) and feel that I might get this excruciating (knife-like) pain.
    My question: Has anyone taken this pill (300mg) as infrequent as me?
    I have taken approximately 4 pills in the last 5 months.
    What I have done since visiting my Neurologist is 15-20 minutes of stationary bicyling followed by 10 minutes of stretching...When this pain originally started about 7 years ago, I agressively did water arobics with hardly any stretching...No doctor ever told me to "stretch" after exercises...and the present neurologist really doesn't confirm that the pain I get is from my back.

  22. #22
    CaliKym is offline New Member
    Join Date
    Nov 2004
    Location
    .
    Posts
    1

    Default

    I went into drug rehab for an addiction to prescription pills and they put me on Neurontin as soon as I walked in the door...
    I am now over 60 days clean YEAH!!!!!!!!!!!
    I now see a psyciatrist who is an addictionologist,and he has me still on the Neurontin I am on 2100mg.....My concern is what I am reading about its effects on the liver..WHen I was in treatment they said my liver enzymes were high...SO why would they of put me on this???????????????????????

    Kymberley

  23. #23
    Casey55 is offline Member
    Join Date
    Nov 2004
    Location
    USA.
    Posts
    131

    Default

    Beverly,

    You are on the lowest dose of Neurontin there is. I just looked up Neurontin for shingles and it suggested working up to 900 -1,800 mg daily, divided into three doses. I can't image 100 mgs would be doing anything for you, which it sounds like it is not. I would call your doctor and see why he hasn't been slowly increasing you up to the recommended dose for shingles. It sounds like are in a lot of pain and discomfort. Neurontin is a great drug for this, but you need more for it to work.

    Nausea can be a common side effect for many drugs. Since it seems like you really need the Neurotin, you could see if your doctor will prescribe an anti-nausea medicine you can take before each dose. Phenegan and Compazine are two good ones. Maybe that would allow you to stay on the Neurontin.

    http://www.drugs.com/forum/forum.asp?FORUM_>>=27

    Good luck, let us know how you make out.
    Casey







  24. #24
    Casey55 is offline Member
    Join Date
    Nov 2004
    Location
    USA.
    Posts
    131

    Default

    I have been on Neurontin as a mood stabilizer for two years and it has worked wonderfully. It doesn't do anything for my anxiety, but I have something else I can take for that on an as needed basis. Just as Astra said, everyone's reactions to drugs are different and absolutely, combinations of medicines taken with it can affect its effectiveness for any of the number of things it is now used for.

    The first time I tried Neurontion for a mood stabilizier, and it didn't help. The second time, I took it with Wellburtin XL and it worked great. So you can see how the combination of meds you are taking can affect its effectiveness for whatever you are taking it for.

    You won't see these different psychiatric uses for Neurontin when you look it up is because they can only report the information for which a medicine was actually tested for. That is the reason you only see Neurontin reported for use of partial seizures and shingles. What happens, once many drugs hit the market, people taking them for the approved reason, some people taking them start to notice another symptom they have for something else is getting better too. There are several drugs, prescribed for something other than depression, but people taking it for its original use, who are also depressed, may notice the depression getting better too. As doctors become aware of this, through shared information reported in JAMA and NEJM etc. it becomes known that the drug can also work for something else. The drug does not have to be approved by the FDA for the other uses in order to be used to other things. As long as it is approved, doctors can use them for other things it seems to help as well. It costs millions of dollars and take many many years, and clinical trials and studies before a drug can be approved by the FDA for a particular use. Since people are reporting it working for other things, there is no reason it has to go back and be tested again for that, it is already approved and so doctors can RX it for other things it seem to help as well.

    The SSRI's (selective seratonin reuptake inhibitors)are a good example of this. The first SSRI to come on the market was Prozac. It was tested and approved for depression. The next SSRI to come out was Luvox and it was tested, approved and marketed for OCD. Since both are SSRIs, it can be assumed that each of those meds can work for what the other is approved for as well. Paxil, Zoloft, Celexa and Lexapro, all SSRIS have since come out, approved for one thing but can work for both. It would be too costly for these drug manufactures to test it for both when it really isn't necessary. Since SSRI have become so widely used, it has been determined they work for other psychiatric disorders as well such as social anxiety.

    There are many many drugs, approved for one use, say heart medicine, high blood pressure medicine, Schizophrenia, on and on, that are being used for other conditions as well.

    Casey

  25. #25
    Myki is offline Junior Member
    Join Date
    Dec 2004
    Location
    USA.
    Posts
    25

    Default

    Hi everyone. Been reading this thread. Lets face it there are dangers with any drug you put in your mouth...just look at over the counter medications.
    for myself..neurontin has been a blessing. I have vit b12 neuropathy affecting both hands and feet. My hands are the worst...anything i touch or touch them feels like boiling hot water on them. Not touching anything they feel like fingers being pulled into palm with sharp shearing burning pain..difficult to move. Neurontin was only thing that helped. I take 600mg in morning..3pm and 600mg at bedtime and can now move fingers without wanting to scream.

  26. #26
    JLM
    JLM is offline New Member
    Join Date
    Aug 2004
    Location
    .
    Posts
    4

    Default

    Released by FDA: 7/1/02. Posted by FDA: 7/18/02

    O. Lucy Castro
    Director, Worldwide Regulatory Strategy
    Pfizer, Inc.
    235 East 42'a Street
    New York, New York 10017-5755

    Re: NDA #s 20-235, 20-882
    Neurontin® (gabapentin)
    MACMIS # 10738

    Dear Ms. Castro:

    Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a model (#NE 102254) for Neurontin (gabapentin) that is in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations because it makes representations about Neurontin which are false or misleading.

    On one side, the model has a presentation of the human brain with full presentation of the hippocampus; the cerebellum, lower medullary structures leading to the spine, and the cerebrum with a prominent mention of the product name below. On the opposite side of the model is a heading "Mechanism of Action," under which are illustrations of cellular activity resulting from the administration of Neurontin and another prominent mention of the product name. The cellular activities within this " Mechanism of Action" include: a decrease in "Action potential frequency," an increase in "GABA synthesis," and increase in "GA-BA release," and the "Regulat[ion] of intracellular Ca++,"

    Specifically, DDMAC has the following objections:

    The presentation on the model of illustrations of cellular activity resulting from the administration of Neurontin ("Mechanism of Action"), in conjunction with the presentation of the human brain, and the prominent display of the name Neurontin makes representations about how Neurontin acts in the human brain. This presentation along with the depiction of the human brain and the prominent display of the name "Neurontin" suggest that the mechanism of action of Neurontin has been established in the human brain. This suggestion of proof of the mechanism of action is false. Specifically, it is contrary to the language in the approved product labeling that states that "[t]he mechanism by which gabapentin [Neurontin] exerts its anticonvulsant action is unknown."

    Furthermore, the full presentation of the aforementioned areas of the human brain accompanied by purported "Mechanism of Action" and the prominent display of the name "Neurontin" is misleading because it suggests that Neurontin is useful for a broader range of CNS conditions than has been demonstrated by substantial evidence (i.e., it can be used for the treatment of any specific or nonspecific brain disorder thought to involve the GABA-ergic neurotransmitter system that can originate in these parts. of the brain). Most obviously, the solo and prominent mention of the name Neurontin suggests that Neurontin can be used as monotherapy for various CNS disorders, notwithstanding that with respect to brain disorders, Neurontin is only indicated as "adjunctive therapy in the treatment of partial seizures with or without secondary generalization in patients over 12 years of age with epilepsy" and as "adjunctive therapy in the treatment of partial seizures in pediatric patients age 3-12 years."

    To address these objections, DDMAC recommends that Pfizer do the following:

    1. Immediately discontinue the use of this model and any other promotional material with the same or similar issues.

    2. Respond to this letter within ten days. Your response should include a statement of your intent to comply with the above, a list of all promotional materials with the same or similar issues, and your methods for discontinuing these promotional materials.

    If you have any questions or comments, please contact the undersigned by facsimile at (301) 5946771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD-42, rm. 1713-20, 5 600 Fishers Lane, Rockville, MD 20857. DDMAC reminds you that only written communications are considered official.

    In all future correspondence regarding this particular matter, please refer to MACMIS >> # 10738 in addition to the NDA number.



    Sincerely,

    Lisa L. Stockbridge, Ph.D.
    Regulatory Reviewer
    Division of Drug Marketing,
    Advertising and Communications


    AHEM, the scientific evidence of the usefullness of Neurontin is sorely lacking. It might be a great placebo thou.

    Regarding FDA approval process: Its actually quite EASY to get ADDITIONAL indications if good data is there, becuase the companies do NOT have to repeat a lot of the expensive toxicology studies they have to do the first go round. And its actually to their ADVANTAGE to do it, because then they can LEGALLY market for that indication. The reason they don't do it, is lack of good data, and then they just illegally push to the doctors. It only takes TWO positive studies to get a drug approved, nevermind the fact that the other 10 you did showed no benefit. That's especially the case with the majority of the SSRI's.

  27. #27
    luddite1965 is offline New Member
    Join Date
    Nov 2005
    Location
    .
    Posts
    3

    Default

    Hello all.
    This is my first post here.
    Thanks for the topic of neurontin and everyone's efforts to experiment and share.
    In case i forget, my specific question is: for those who benefit from neurontin, do people develop a tolerance to it over the longer term?
    I have been on 600mg at night to help the quality of my sleep for 3 years, so i wonder if i might have lost most its original benefit.
    Thanks in advance to anyone who can answer that question for me,

    Geoge

    P.S.
    1. I am reassured and inspired by others' efforts and struggles.
    2. I have CFS/FM for 18 years, and am unusually insensitive to drugs.
    3. My prioritized complaints are sleep disorders, fatigue, cognition, pain.
    4. My current sleep regimen is 3mg sl melatonin and 25mg benadryl (which are the only 2 things that ever helped me get to sleep) plus 600mg neurontin and 200mg celebrex to help deepen my sleep quality.
    5. The only drug that ever dramatically helped my sleep quality was klonopin (and restoril for a while), which i replaced 3 years ago with neurontin 600mg because of the issue of long-term tolerance and benzo's.
    6. I'm up to 400mg of experimenting with lyrica (suggested replacement for neurontin) as i type this, feeling no benefit except some dizziness; yet neurontin does still seem to help my sleep quality.
    7. Thanks again for listening and sharing.
    8. The expression "vitamin G" has me rolling on the floor laughing my ass off.

  28. #28
    rosetaz is offline New Member
    Join Date
    Nov 2005
    Location
    USA.
    Posts
    4

    Default

    quote:Originally posted by painweaner

    does anyone have info on neurontin and hair loss in women?
    I have not heard of any hair loss with Neurontin but many people have hair loss with Topamax.

    I've been taking Neurontin for about a year. The only negative side effect that I hate is the weight gain. I seem to have no feeling of fullness and can easily overeat. This is not me. I have always filled up fast. I think mostly I hold a lot of water since I am watching my diet.

  29. #29
    Casey55 is offline Member
    Join Date
    Nov 2004
    Location
    USA.
    Posts
    131

    Default

    I have been on Neurontin for almost 3 yrs.

    I see many of you reporting weight gain and sexual side effects on Neurontin.

    I have had neither, in fact I have lost 50 lbs while on it. I looked it up on several sites and the only indication for weight gain is in children and I don't find sexual side effects reported anywhere.

    I take it for a mood stabilizer. It is often given along with an antidepressant. I was just wondering how many of you reporting the above side effects are also on an antidepresant with it.

    If you are and it is one of the SSRI's, they are notorious for weight gain and sexual side effects. Or are there any other meds your are on that could be causing these side effects?

  30. #30
    mcm
    mcm is offline New Member
    Join Date
    Nov 2005
    Location
    .
    Posts
    1

    Default

    I started using neurontine after seeing a neurologist.My symptoms were extreme leg pain that would wake me at night and first thing in the morning.WhenI put my feet on the ground I would shreek with the pain.I felt high on the medication peaking at 2 hours after taking it.I liked the feeling of well being but I also felt there was a potential for addiction.It did help the pain immensely and seemed to heal the inflammed nerve endings.Then I started chiropractic treatments with corrective adjustments.Slowly I titrated the medication dose and within 7 months discontinued the med.Three years later I'm still receiving chiropractic treatments,off all meds and can function as a whole human being!

Page 1 of 2 12 LastLast

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22