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FDA Approves Lyrica CR (pregabalin) Extended-Release Tablets for Neuropathic Pain Conditions

Posted 17 Oct 2017 by Drugs.com

October 12, 2017 - Pfizer Inc. (NYSE: PFE) announced today that the United States Food and Drug Administration (FDA) has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). Lyrica CR did not receive approval for the management of fibromyalgia. “Lyrica CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” said James M. Rusnak, MD, PhD, Chief Development Officer, Internal Medicine, Pfizer Global Product Development. “It provides an important option for patients and health care providers managing these often debilitating pain conditions.” The efficacy and safety of Lyrica CR in PHN was established in a randomized placebo-controlled clinical trial conducted in a t ... Read more

Related support groups: Lyrica, Neuropathic Pain, Pregabalin, Diabetic Neuropathy, Postherpetic Neuralgia

Number of Americans With Epilepsy at Record Level

Posted 10 Aug 2017 by Drugs.com

THURSDAY, Aug. 10, 2017 – More Americans than ever are living with epilepsy, federal health officials reported Thursday. According to the new report, 1.2 percent of the population – about 3 million adults and 470,000 children – were being treated for epilepsy or had experienced recent seizures in 2015, the researchers from the U.S. Centers for Disease Control and Prevention said. The number of adults with active epilepsy rose from 2.3 million in 2010. Epilepsy among children rose by 20,000 between 2007 and 2015, according to the report's coauthor, Rosemarie Kobau, the head of the CDC's epilepsy program. "The increase is probably because of population growth," Kobau said. "We don't know if other factors are involved." The report, published Aug. 11 in the CDC's Morbidity and Mortality Weekly Report, offers epilepsy estimates for every state for the first time, which shows the condition ... Read more

Related support groups: Klonopin, Gabapentin, Seizures, Clonazepam, Ativan, Lyrica, Valium, Topamax, Lorazepam, Neurontin, Epilepsy, Diazepam, Topiramate, Dilantin, Pregabalin, Seizure Prevention, Zonisamide, Diamox, Phenytoin, Zonegran

Doctors May Be Over-Prescribing Seizure Drugs to Treat Pain

Posted 3 Aug 2017 by Drugs.com

WEDNESDAY, Aug. 2, 2017 – Physicians might be relying too heavily on "off-label" use of epilepsy drugs as an alternative to prescribing narcotic painkillers, two experts in internal medicine contend. Doctors are prescribing the anti-seizure drugs gabapentin (Neurontin) and pregabalin (Lyrica) to treat pain more frequently, partly in response to the opioid epidemic in the United States, said Dr. Allan Brett. He's a professor of clinical internal medicine with the University of South Carolina School of Medicine in Columbia. However, the drugs might not be doing any good for many people suffering from chronic pain, Brett said. That's because the medications are only FDA-approved to treat certain types of pain. Yet, "increasing numbers of patients [are] being prescribed either of these drugs for any kind of pain symptoms," he said. Brett and co-author Dr. Christopher Goodman, an assistant ... Read more

Related support groups: Pain, Suboxone, Oxycodone, Back Pain, Tramadol, Hydrocodone, Methadone, Percocet, Klonopin, Gabapentin, OxyContin, Vicodin, Norco, Fentanyl, Clonazepam, Ativan, Morphine, Lyrica, Valium, Chronic Pain

Drug No Better Than Placebo for Lower Back, Leg Pain

Posted 23 Mar 2017 by Drugs.com

WEDNESDAY, March 22, 2017 – The widely prescribed pain drug pregabalin (brand name: Lyrica) may be no better than a placebo when it comes to treating the back and leg pain known as sciatica, a new clinical trial suggests. The study, published March 22 in the New England Journal of Medicine, found that sciatica patients improved to the same degree whether they were given pregabalin or placebo capsules. Sciatica refers to pain that radiates along the sciatic nerve, which branches from the low back through the hips and down each leg, according to the U.S. National Institutes of Health. The pain typically shoots down the back of the leg, and some people also have numbness, tingling or muscle weakness. The problem is caused by compression of the sciatic nerve – possibly from a herniated spinal disc. Pregabalin is prescribed to treat various forms of nerve-related pain. In the United ... Read more

Related support groups: Back Pain, Lyrica, Ibuprofen, Naproxen, Sciatica, Advil, Aleve, Pregabalin, Herniated Disc, Motrin, Scoliosis, Vicoprofen, Advil PM, Treximet, Advil Cold and Sinus, Naprosyn, Vimovo, Naprelan '375', Aleve PM, Naprelan

Opioid Painkillers Raise Deadly Heart Risks for Some: Study

Posted 14 Jun 2016 by Drugs.com

TUESDAY, June 14, 2016 – While the dangers of overdose among patients prescribed powerful opioid painkillers such as Oxycontin and fentanyl are well known, a new study found unexpected heart risks with the medications. Patients who had just been prescribed an opioid painkiller had a 64 percent higher risk of early death when compared to patients who were given an alternative pain medication. But much of that increased risk was related to the onset of breathing difficulties during sleep, followed by heart rhythm irregularities and other cardiovascular complications. "We were not surprised by the increased risk for overdose deaths, which is well known," noted study author Wayne Ray, from the department of health policy at Vanderbilt University School of Medicine in Nashville, Tenn. "However, the large increase in cardiovascular death risk is a novel finding," Ray said. "[And] it suggests ... Read more

Related support groups: Pain, Oxycodone, Back Pain, Percocet, Gabapentin, OxyContin, Fentanyl, Lyrica, Chronic Pain, Neurontin, Heart Disease, Arrhythmia, Sciatica, Tegretol, Roxicodone, Pregabalin, Carbamazepine, Endocet, Duragesic, Scoliosis

Pain, Epilepsy Drug Lyrica May Increase Birth Defects Risk, Study Suggests

Posted 18 May 2016 by Drugs.com

WEDNESDAY, May 18, 2016 – The widely prescribed drug pregabalin (Lyrica) may slightly increase the risk for birth defects, a new study suggests. In a small study, researchers found that among women taking Lyrica during the first trimester of pregnancy, 6 percent had infants with major birth defects. In women who weren't taking the drug, 2 percent had a baby with a major birth defect, the study found. "These results should be taken with caution," said study senior author Dr. Thierry Buclin, from the Swiss Teratogen Information Service and the division of clinical pharmacology at the Lausanne University Hospital, in Switzerland. "It's a warning, but it cannot be taken as a certainty." Lyrica is prescribed for a range of health problems, including epilepsy, fibromyalgia and anxiety. The new study findings should be investigated further, Buclin said. "We should not unduly alarm ... Read more

Related support groups: Birth Control, Anxiety, Generalized Anxiety Disorder, Contraception, Anxiety and Stress, Fibromyalgia, Seizures, Lyrica, Social Anxiety Disorder, Epilepsy, Pregabalin, Delivery, Performance Anxiety, Premature Labor, Hydrocephalus, Labor Pain, Brain Anomalies incl Congenital, Cesarean Section, Labor and Delivery including Augmentation, Apnea of Prematurity

New Drug Shows Promise for Restless Legs Syndrome: Study

Posted 12 Feb 2014 by Drugs.com

WEDNESDAY, Feb. 12, 2014 – For relieving symptoms of restless legs syndrome and slowing its progression, the drug pregabalin (Lyrica) outperformed the current standard medication in a head-to-head comparison, a new study found. Pramipexole (Mirapex), which is commonly used to treat this neurological disease, makes many people worse, said lead researcher Richard Allen, an associate professor of neurology at Johns Hopkins University School of Medicine in Baltimore. Lyrica works just as well and doesn't worsen the condition, Allen said. People with restless legs syndrome – now also known as Willis-Ekbom disease – feel throbbing, creeping or other unpleasant sensations in the legs and an uncontrollable urge to move them. Symptoms occur primarily at night, and most people with restless legs syndrome have trouble falling asleep and staying asleep. Moving the legs relieves the discomfort; ... Read more

Related support groups: Lyrica, Restless Legs Syndrome, Pregabalin

Epilepsy Drugs in Pregnancy May Affect Infants' Fine Motor Skills

Posted 25 Sep 2013 by Drugs.com

WEDNESDAY, Sept. 25 – Young children exposed to epilepsy drugs in the womb are at increased risk of having impaired fine motor skills, according to a new study. Exposure to the drugs in breast milk, however, does not appear to pose a threat. Researchers looked at data collected from Norwegian mothers about their children's language, behavior, and motor and social skills at the ages of 6 months, 18 months and 36 months. The women also provided information on breast-feeding during the first year for the study, which was published online Sept. 23 in the journal JAMA Neurology. Of the children in the study, 223 were exposed to one or more epilepsy drugs in the womb. At age 6 months, 11.5 percent of infants whose mothers took epilepsy drugs during pregnancy had impaired fine motor skills (which involve small muscle movements) compared with less than 5 percent of those who were not exposed ... Read more

Related support groups: Klonopin, Seizures, Clonazepam, Ativan, Lyrica, Valium, Lamictal, Topamax, Lorazepam, Depakote, Epilepsy, Diazepam, Keppra, Lamotrigine, Topiramate, Tegretol, Dilantin, Pregabalin, Trileptal, Carbamazepine

Drugs May Help Relieve Restless Legs Syndrome

Posted 4 Mar 2013 by Drugs.com

MONDAY, March 4 – People suffering from restless legs syndrome may find some relief by taking one of several drugs approved to treat the condition, a new review confirms. The medications, which include Requip (ropinirole), levodopa, Neurontin (gabapentin) and Lyrica (pregabalin), appear to reduce symptoms of the syndrome in more than 60 percent of patients, researchers report. The first two drugs raise dopamine levels in the body, and the last two drugs reduce the amount of calcium reaching brain cells and trigger the production of other chemicals that help reduce pain. Dopamine is a brain chemical that regulates movement and mood. "Physicians and patients now have better information on the effectiveness and harms of two types of drug treatments for patients with at least moderately severe restless legs symptoms in which to guide treatment choices," said review author Dr. Timothy Wilt, ... Read more

Related support groups: Gabapentin, Lyrica, Restless Legs Syndrome, Neurontin, Pregabalin, Requip, Ropinirole, Levodopa, Gralise, Horizant, Requip XL, Requip Starter Kit, Gabarone, Repreve, ReQuip Follow on Pack, Dopar, ReQuip Starter Pack, Larodopa, Fanatrex

Lupin Receives FDA Approval for Generic Lyrica

Posted 6 Jul 2012 by Drugs.com

MUMBAI and BALTIMORE, July 5, 2012/PRNewswire-FirstCall/ --Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received final approval for its Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg from the United States Food and Drugs Administration (FDA) to market a generic version of C.P. Pharmaceuticals C.V., Lyrica (pregabalin) capsules. Lupin's Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg are the AB-rated generic equivalent of Lyrica capsules, which is indicated for neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and fibromyalgia. Lyrica Capsules had annual U.S sales of approximately $1.8 billion for the twelve months ending March 2012 (IMS ... Read more

Related support groups: Lyrica, Pregabalin

FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review

Posted 21 Jun 2012 by Drugs.com

NEW YORK--(BUSINESS WIRE)--Jun 21, 2012 - Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the use of Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury. Lyrica received a priority review designation for this new indication from the FDA. More than 100,000 patients – approximately 40 percent of the 270,000 patients with spinal cord injury in the United States - suffer from this chronic, complex pain condition. Neuropathic pain associated with spinal cord injury can be severely debilitating and may significantly hinder rehabilitation and the ability to regain function. “This milestone represents an important opportunity for physicians to more effectively manage the debilitating neuropathic pain that often accompanies spinal cord injury,” said clinical study investigator Diana Cardenas, MD, MHA, prof ... Read more

Related support groups: Lyrica, Pregabalin, Neuropathy

Epilepsy Drugs Don't Raise Suicide Risk, Study Shows

Posted 5 Aug 2010 by Drugs.com

WEDNESDAY, Aug. 4 – In 2008, the U.S. Food and Drug Administration required epilepsy medications to bear a warning label about an increased risk of suicidal behaviors. The move came after an agency review of 199 studies that found patients taking the drugs showed about twice the risk of suicidal behavior. But now a study of more than 5 million patients contradicts the FDA's findings. It suggests that the increased risk of suicide has more to do with the conditions for which these drugs are prescribed than the medications themselves. For the study, researchers in Spain and the United States evaluated the health records of primary care patients in England. They found that people with epilepsy who currently use an antiepileptic drug are at no greater risk of suicide-related events than those who aren't taking the medications. "In our opinion, in the long term, it is not the drugs ... Read more

Related support groups: Gabapentin, Lyrica, Lamictal, Topamax, Neurontin, Depakote, Keppra, Lamotrigine, Topiramate, Tegretol, Pregabalin, Trileptal, Carbamazepine, Depakote ER, Levetiracetam, Oxcarbazepine, Zonisamide, Divalproex Sodium, Tegretol XR, Zonegran

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Neuropathic Pain, Fibromyalgia, Diabetic Neuropathy, Diabetic Nerve Damage, Neuralgia, Persisting Pain, Shingles, Postherpetic Neuralgia, Generalized Anxiety Disorder, Epilepsy, view more... Dercum's Disease, Pain, Peripheral Neuropathy, Spondylolisthesis, Occipital Neuralgia, Reflex Sympathetic Dystrophy Syndrome, Restless Legs Syndrome, Syringomyelia, Small Fiber Neuropathy, Migraine Prevention, Migraine Prophylaxis

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