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FDA issues draft guidance on abuse-deterrent opioids

Posted 9 Jan 2013 by Drugs.com

January 9, 2013 – The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies. “The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation,” said FDA Commissioner Margaret A. Hamburg, M.D. “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.” Opioids can ... Read more

Related support groups: Pain, Suboxone, Oxycodone, Methadone, Hydrocodone, OxyContin, Vicodin, Morphine, Opiate Dependence, Norco, Fentanyl, Lortab, Opiate Withdrawal, Codeine, Opana, Subutex, Dilaudid, Opana ER, Nucynta, Roxicodone

FDA Medwatch Alert: Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets

Posted 28 Dec 2012 by Drugs.com

Qualitest/Endo Health Mylan UPDATE 12/21/2012: Mylan announced a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573). The three lots, manufactured by Qualitest Pharmaceuticals, were repackaged and distributed by Mylan in unit dose (CD100) under the UDL Laboratories label. The lot numbers are Lots 3037841, 3040859 and 3042573. [Posted 12/07/2012] ISSUE: Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased ... Read more

Related support groups: Vicodin, Norco, Lortab, Acetaminophen/Hydrocodone, Lorcet 10/650, Vicodin ES, Lortab 10/500, Vicodin HP, Lorcet Plus, Anexsia, Lortab 5/500, Lortab 7.5/500, Xodol, Lorcet HD, Hy-Phen, Maxidone, Zydone, Anolor DH5, T-Gesic, Liquicet

FDA Medwatch Alert: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets

Posted 7 Dec 2012 by Drugs.com

ISSUE: Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or ... Read more

Related support groups: Pain, Vicodin, Norco, Lortab, Acetaminophen/Hydrocodone, Lorcet 10/650, Vicodin ES, Lortab 10/500, Vicodin HP, Lorcet Plus, Anexsia, Lortab 5/500, Lortab 7.5/500, Xodol, Lorcet HD, Hy-Phen, Maxidone, Zydone, Anolor DH5, T-Gesic

Painkiller Abuse by Kids Way Up, Study Finds

Posted 17 Oct 2012 by Drugs.com

WEDNESDAY, Oct. 17 – The rate of prescription painkiller abuse among American youth is 40 percent higher than in previous generations, and it is now the second most common type of illegal drug use after marijuana, according to a new study. The current generation's abuse of prescription pain medications such as vicodin, valium and oxycontin is "higher than any generation ever measured," study author Richard Miech, a professor of sociology at the University of Colorado, Denver, said in a university news release. The researchers analyzed data from the National Survey on Drug Use and Health from 1985 to 2009, and found that prescription painkiller abuse led to: A 129 percent increase in emergency department visits between 2004 and 2009. A more than 500 percent increase in the number of people seeking treatment for addiction to prescription opioids between 1997 and 2007. A threefold ... Read more

Related support groups: Suboxone, Oxycodone, Methadone, Hydrocodone, OxyContin, Vicodin, Morphine, Norco, Fentanyl, Lortab, Codeine, Opana, Subutex, Dilaudid, Opana ER, Nucynta, Roxicodone, Butrans, MS Contin, Hydromorphone

FDA Medwatch Alert: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Watson Laboratories): Recall - Potential for Oversized and Superpotent Tablets

Posted 24 Sep 2012 by Drugs.com

ISSUE: Watson Laboratories, Inc. notified the public of a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg (Lot Numbers 519406A and 521759A, both with the expiry date April 2014, distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide). A complaint was received for tablets that were thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or Acetaminophen. Unintentional ingestion of excessive amounts of acetaminophen may potentially result in an adverse event, including liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more ... Read more

Related support groups: Pain, Vicodin, Norco, Lortab, Acetaminophen/Hydrocodone, Lorcet 10/650, Vicodin ES, Lortab 10/500, Vicodin HP, Lorcet Plus, Anexsia, Lortab 5/500, Lortab 7.5/500, Xodol, Lorcet HD, Hy-Phen, Maxidone, Zydone, Anolor DH5, T-Gesic

'Doctor Shopping' Tied to Fatal Prescription Drug Overdoses

Posted 16 Sep 2012 by Drugs.com

FRIDAY, Sept. 14 – People who visit multiple doctors and pharmacies to get medications are at greater risk of dying from a prescription drug overdose, according to a new study. Drug-monitoring programs might help identify patients who engage in what's known as "doctor shopping" or "pharmacy shopping," the researchers said. "These programs currently exist in most states, and efforts are under way to create one large program that would compile the controlled-substance prescription data from all participating states," Marie Abate, a professor at the West Virginia University School of Pharmacy and faculty affiliate in the university's Injury Control Center, said in a university news release. One such program, the West Virginia Controlled Substance Monitoring Program (CSMP), collects information on every controlled-substance prescription filled in the state. The study authors examined the ... Read more

Related support groups: Suboxone, Oxycodone, Methadone, Hydrocodone, OxyContin, Vicodin, Morphine, Norco, Fentanyl, Lortab, Codeine, Opana, Subutex, Dilaudid, Opana ER, Nucynta, Roxicodone, Butrans, MS Contin, Hydromorphone

FDA Medwatch Alert: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets

Posted 11 Sep 2012 by Drugs.com

ISSUE:  Today, Qualitest, a subsidiary of Endo Health Solutions,issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. BACKGROUND: Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. The affected lot, C1440512A, was distributed between May 14 and Aug. 3, 2012 to wholesale ... Read more

Related support groups: Pain, Vicodin, Norco, Lortab, Acetaminophen/Hydrocodone, Lorcet 10/650, Vicodin ES, Lortab 10/500, Vicodin HP, Lorcet Plus, Anexsia, Lortab 5/500, Lortab 7.5/500, Xodol, Lorcet HD, Hy-Phen, Maxidone, Zydone, Anolor DH5, T-Gesic

Teens Who Drink, Smoke More Likely to Abuse Painkillers Later: Study

Posted 21 Aug 2012 by Drugs.com

TUESDAY, Aug. 21 – Teenagers who smoke or drink are two to three times more likely to abuse prescription painkillers later on in life, new research shows. Researchers from Yale University analyzed information collected from young adults aged 18 to 25 from the 2006-2008 U.S. National Survey on Drug Use and Health. About 12 percent of the young adults surveyed said they currently abused prescription opioids. Of those, 57 percent had abused alcohol as teens; 56 percent smoked cigarettes and 34 percent used marijuana. About 3.5 million young adults abuse prescription opioids, "and this number is growing," study lead author Dr. Lynn Fiellin, associate professor of medicine at Yale, said in a university news release. Gender was also associated with risk of opioid abuse, the investigators found. Among men, use of cigarettes, alcohol and marijuana when they were teenagers was associated with a ... Read more

Related support groups: Suboxone, Oxycodone, Methadone, Hydrocodone, OxyContin, Vicodin, Morphine, Norco, Fentanyl, Lortab, Codeine, Opana, Subutex, Smoking, Dilaudid, Opana ER, Nucynta, Roxicodone, Butrans, MS Contin

Teach Prescribers About Dangers of Long-Acting Pain Meds: FDA

Posted 9 Jul 2012 by Drugs.com

MONDAY, July 9 – As part of its efforts to curb the abuse of narcotic painkillers, the U.S. Food and Drug Administration is requiring drug makers to educate doctors about the risks of long-acting and extended-release forms of the drugs. "Prescription-drug abuse is our nation's fastest-growing drug problem," FDA commissioner Dr. Margaret Hamburg said during a Monday afternoon press conference. Commonly prescribed drugs that come in longer-acting forms include oxycodone, morphine and fentanyl. The continuing-education programs will be based on FDA-created blueprints. The agency expects the more than 20 companies that make these drugs to provide grants to firms that specialize in medical continuing education. These firms will, in turn, develop and administer the programs under FDA supervision and provide them to doctors for free. Although all opioid painkillers carry risk of abuse, ... Read more

Related support groups: Pain, Suboxone, Oxycodone, Methadone, Percocet, Hydrocodone, OxyContin, Vicodin, Morphine, Norco, Fentanyl, Lortab, Codeine, Opana, Subutex, Dilaudid, Opana ER, Nucynta, Roxicodone, Butrans

Methadone for Pain Relief Leading Cause of Fatal Overdoses: CDC

Posted 3 Jul 2012 by Drugs.com

TUESDAY, July 3 – Although methadone accounts for only 2 percent of the painkiller prescriptions in the United States, it is tied to more than 30 percent of painkiller overdose deaths, according to a government report released Tuesday. "There have been about 4 million prescriptions for methadone each year, and about 5,000 Americans die from methadone overdoses each year," said Dr. Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention. Methadone is riskier than other opioid painkillers because it builds up in the body and may alter breathing or heart rhythm, the report explained. Since the 1960s, methadone has been used safely as a heroin substitute in treating drug addiction. Its use as a painkiller has grown since the 1990s, the report indicated. Now, methadone is overused for pain, Frieden said. Abuse of methadone for nonmedical purposes has also led to ... Read more

Related support groups: Pain, Oxycodone, Methadone, OxyContin, Vicodin, Opiate Dependence, Norco, Lortab, Opiate Withdrawal, Roxicodone, Diskets, Acetaminophen/Hydrocodone, Methadose, Lorcet 10/650, Vicodin ES, Lortab 10/500, Lorcet Plus, Vicodin HP, Anexsia, Opioid Overdose

Tylenol Overdose Can Be Deadly for a Child

Posted 10 Jun 2012 by Drugs.com

FRIDAY, June 8 – Overdoses of the pain and fever drug acetaminophen (brand name Tylenol) are a leading cause of acute liver failure in children, and more public education is needed to warn parents and others of this danger, experts say. Acetaminophen is a widely available over-the-counter medication, but repeated doses above the recommended level, or overdoses due to errors or intentional consumption, can lead to acute liver failure and even death in children, according to Dr. Rod Lim, of the Children's Hospital at the London Health Sciences Center in Ontario, Canada, and colleagues. Writing in the June 4 issue of the Canadian Medical Association Journal, they cite a case study of parents who mistakenly gave their 22-day-old baby boy too much acetaminophen after a circumcision. The mistake was discovered, and the child recovered after receiving intravenous treatment with ... Read more

Related support groups: Percocet, Vicodin, Norco, Tylenol, Lortab, Acetaminophen, Fioricet, Paracetamol, Endocet, Excedrin, Darvocet-N 100, Tylenol PM, NyQuil, Acetaminophen/Hydrocodone, Ultracet, Tylenol with Codeine, Percocet 10/325, Roxicet, Tylenol with Codeine 3, Panadol

Mental Health Woes Raise Odds for Prescription Painkiller Abuse

Posted 10 Jun 2012 by Drugs.com

FRIDAY, June 8 – Teens and young adults with mental health disorders are at increased risk for long-term use of presciption painkillers such as Vicodin and Oxycontin, according to a new study. Researchers examined data from more than 62,000 young people, aged 13 to 24, in the Western, Midwestern and Southwestern United States. Those with mental health disorders were more likely to be prescribed opioids for chronic pain and 2.4 times more likely to become long-term opioid users than those without mental health disorders. Long-term opioid use was more common among males, older youth and those who lived in poorer communities with more white residents. Long-term use was defined as using opioids for more than 90 days within a six-month period, with no gap in use of more than 30 days. The study appeared June 6 in the Journal of Adolescent Health. "There are a number of reasons adolescents ... Read more

Related support groups: Oxycodone, Methadone, Hydrocodone, OxyContin, Vicodin, Morphine, Norco, Fentanyl, Lortab, Codeine, Opana, Subutex, Dilaudid, Opana ER, Nucynta, Roxicodone, Butrans, MS Contin, Hydromorphone, Buprenorphine

Many Americans Taking Too Much Acetaminophen

Posted 2 Jun 2012 by Drugs.com

FRIDAY, June 1 – Many U.S. adults are at risk for overdosing on over-the-counter pain relievers containing acetaminophen, according to a new study. Acetaminophen (Tylenol) is the most commonly used over-the-counter pain medication in the United States, and acetaminophen overdose is the leading cause of acute liver failure, according to researchers from Northwestern University in Evanston, Ill.. The researchers interviewed 500 adult patients at outpatient general medicine clinics in Atlanta and Chicago. More than half had used acetaminophen in the past six months and 19 percent said they were heavy users, which means they took acetaminophen every day or a couple of times a week. The study authors then assessed whether the patients understood the recommended dosage of acetaminophen products and if they were able to take them safely. The results showed that nearly a quarter of the ... Read more

Related support groups: Percocet, Vicodin, Norco, Tylenol, Lortab, Acetaminophen, Fioricet, Paracetamol, Endocet, Excedrin, Darvocet-N 100, Tylenol PM, NyQuil, Acetaminophen/Hydrocodone, Ultracet, Tylenol with Codeine, Percocet 10/325, Roxicet, Tylenol with Codeine 3, Panadol

Patients May Receive Too Much Acetaminophen in Hospital

Posted 23 May 2012 by Drugs.com

WEDNESDAY, May 23 – Roughly 2.5 percent of admitted hospital patients may receive more than the safe daily cumulative dose of the pain-reliever acetaminophen, best known as Tylenol, on at least one day, according to a new U.S. study. Patients on more than one drug containing acetaminophen often consume more than the recommended 4 grams per day of the drug, the researchers from Thomas Jefferson University Hospital in Philadelphia found. Together, two tablets of extra-strength Tylenol contain 1 gram of acetaminophen, commonly used to relieve pain and reduce fever. Over the course of two years, researchers led by Dr. Jesse Civan examined 46,000 hospital admissions and the medications those patients were given. They found that on at least one day of hospitalization, roughly 1,100 patients received more than 4 grams of acetaminophen in the form of Tylenol, Percocet and similar drugs. The ... Read more

Related support groups: Percocet, Vicodin, Norco, Tylenol, Lortab, Acetaminophen, Fioricet, Paracetamol, Endocet, Excedrin, Darvocet-N 100, Tylenol PM, NyQuil, Acetaminophen/Hydrocodone, Ultracet, Tylenol with Codeine, Percocet 10/325, Roxicet, Tylenol with Codeine 3, Panadol

Kids Most Likely to Start Abusing Painkillers at 16: Study

Posted 7 May 2012 by Drugs.com

MONDAY, May 7 – Among U.S. adolescents, misuse of prescription painkillers peaks at age 16, earlier than thought, a new large survey analysis reveals. "What our findings suggest is that if we wait until the last year of high school or college to take some kind of action that could prevent the misuse of opioid painkillers, it'll be a case of too little, too late," cautioned study co-author James Anthony, a professor of epidemiology and biostatistics in the department of epidemiology and biostatistics at Michigan State University in East Lansing. Many experts consider "extramedical" painkiller abuse – taking pain drugs such as OxyContin (oxycodone) and Vicodin (hydrocodone) to get high rather than to relieve extreme pain – the country's most serious drug challenge. Some kids had already misused these drugs by age 13 or 14, or eighth grade, the researchers found. Anthony and his ... Read more

Related support groups: Pain, Suboxone, Oxycodone, Methadone, Percocet, Hydrocodone, OxyContin, Vicodin, Morphine, Norco, Fentanyl, Lortab, Codeine, Opana, Subutex, Dilaudid, Opana ER, Nucynta, Roxicodone, Butrans

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