Darvon and Darvocet withdrawals continue to affect the pharmaceutical market
November 23, 2010 at 11:22 am 1 comment
On Monday, Cornerstone Therapeutics Inc, withdrew three of its generic products per FDA recommendation. Cornerstone’s affected products include Balacet 325 CIV, Propoxyphene Napsylate and Acetaminophen Tablets CIV and Propoxyphene Napsylate and Acetaminophen Tablets CIV. (link)
Last week, the FDA ordered Xanodyne Pharmaceuticals to withdraw the name-brand versions propoxyphene, a drug used to treat mild to moderate pain. Issues arose with propoxyphene after a study revealed that the drug places patients, from healthy to those weakened by illness, at risk for serious to sometimes fatal arrhythmias.
Propoxyphene was first approved in 1957. Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug. (link) The efficacy and safety of propoxyphene, first approved by the FDA in 1957, was the subject of a January 2009 FDA advisory committee meeting. After considering the data submitted with the drug’s original application and subsequent medical literature and post-market databases, the committee voted 14 to 12 against continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac events would be relevant in weighing its risks and benefits, based on the release. (link) News of the withdrawals came as no shock to the European markets as they had ordered the withdrawal of propoxyphene in 2009.
American Council on Science and Health Doctor Gilbert Ross is happy with this withdrawal.
I do, however, agree that Darvon needed to be removed from the market–let’s just say public health will not suffer as a result of its withdrawal. LINK
If you or someone you know is currently taking Darvon, Darvocet, or a some generic form, please advise them to contact their doctor immediately to discuss their situation. If you have been injured while taking Darvon, Darvocet, or any generic, please CONTACT us immediately for a free case consultation. The Ronan Law Firm has over 25 years of litigation experience. The Ronan Law Firm has successfully represented clients all across the nation in pharmaceutical cases such as Vioxx, Fen-Phen, Avandia and more. Why let uncertainty prevent you from proper recovery for your injury? CONTACT the Ronan Law Firm with any questions or concerns that you may have.
Entry filed under: Darvocet, Darvon. Tags: acetaminophen, arrythmia, Avandia, Balacet 325 CIV, Cornerstone Therapeutics, Darvocet, Darvon, Fen-Phen, generic pharmaceutical, heart, irregular heart beat, litigation, pain reliever, pharmaceutical litigation, Propoxyphene, Propoxyphene Napsylate and Acetaminophen Tablets CIV and Propoxyphene Napsylate and Acetaminophen Tablets CIV, Vioxx, xanodyne, xanodyne pharmaceuticals.
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Terence Mix | November 27, 2010 at 1:52 am
The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?
This history is not unique. On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing Meridia from the American market, 9 months after the weight-loss drug was removed by the European Union. Earlier, the FDA had only strengthened the warning on the drug’s labeling, cautioning its users about the risk of heart attacks and strokes. On September 23, 2010, the FDA decided to allow Avandia to remain on the market, while the European Medicines Agency decided to pull the plug on the drug in Europe. These decisions are somewhat reminiscent of the history involving the drug, Cylert, which was withdrawn by the FDA in 2005 because it was causing severe liver damage to children taking it for ADHD – eight years after it was withdrawn by Great Britain.
This pattern of increasing warnings while other countries are removing drugs that do not belong on the market is only a small sample of why our FDA and its oversight of drugs is no longer the gold standard of the world. Meanwhile, thousands of Americans are dying unnecessarily. As many as 230,000 per year die in the United States as a result of an adverse reaction to prescription and/or nonprescription drugs – a number that can be cut in half.
Changes need to be made and they need to happen now. And it has got to start by eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial entity, such as the National Institutes of Health.
For everyone who is in agreement with taking some action, I would urge you to go to the website, http://www.FDAreformpetition.com and sign my petition to Congress demanding a change. Only if the citizens of this country speak in a strong and unified voice will we catch the attention of Congress and impress upon it the need for such a change.