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Popular Painkillers to Be Pulled from Market | 24-7-news.com cialis online

Popular Painkillers to Be Pulled from Market

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Both Darvon and Darvocet can lead to serious complications, some of which can be fatal and result in sudden death. Both of the prescription painkillers are being removed from the market at the request of the Food & Drug Administration (FDA).

Serious side effects of Darvon and Darvocet can include.

• Fatal Abnormal Heart Rhythms,
• Cardiac disorders,
• Arrhythmia,
• Bradycardia,
• Cardiac/Respiratory Arrest,
• Congestive Arrest,
• Congestive Heart Failure (CHF),
• Tachycardia,
• Myocardial Infarction (MI)

Darvon and Darvocet both contains the active ingredient propoxyphene, were first developed by Eli Lilly & Co. 50 years ago. Eli Lilly no longer sells the drug, but generic drug makers, including Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, continued to market propoxyphene. In 2009, more than 10 million prescriptions were written for propoxyphene-containing drugs.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency has since has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death, the FDA said. As a result, Xanodyne Pharmaceuticals has agreed to remove the two painkillers from the market.

For years, Darvocet and Darvon have been the subject of safety concerns. In 2006, the consumer advocacy group Public Citizen asked the FDA to ban Darvon, as well as Darvocet (a combination propoxyphene and acetaminophen), saying the drugs had been associated with the deaths of at least 2,110 people between 1981 and 1999. Dr. Sidney Wolfe, the group’s director, also asserted that propoxyphene was a relatively weak painkiller and posed an unacceptable toxic risk to the millions of patients prescribed it each year.

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