Friday, November 26, 2010

Darvocet and Darvon pulled from U.S. market

U.S. Food and Drug Administration pulls Darvocet and Darvon off the sector

The Food and Drug Administration has officially made the recommendation that Darvocet be pulled off the market. The maker of the drug has complied. The painkilling drug causes dangerous abnormal heart rhythms. Doctors have been told to quit prescribing Darvocet, though the recommendation also advised individuals with the prescription to continue taking it.

No more Darvocet

The FDA asked that Darvocet and Darvon were removed from the market. The makers did this. Darvocet has the active ingredient Propoxyphene in it. Irregular heart rhythms could be caused by this. As early as 2005, propoxyphene-containing drugs like Darvocet were already being pulled off the market by drug agencies in the European Union and United Kingdom. Doctors can no longer write Darvocet prescriptions while pharmacists were told to stop filling prescriptions.

Darvocet questioned in 2009

The active ingredient in Darvocet was first approved by the FDA in 1957. For years, many wondered about the safety of the drug. This caused an FDA panel to suggest the drug get taken off the market in January 2006. The FDA rejected this recommendation, though, in favor of further study of the drug. Drugmaker Lilly sponsored studies dating back as far as 31 years ago that stated, “cardiac conduction depression may be a factor in some of the (human) cardiac toxicities associated with propoxyphene overdose.”

What the Darvocet ban will cost

FDA drug approval and review procedures are being questioned by numerous as a result of the ban on Darvocet. Prescriptions for Darvocet or propoxyphene are filled a lot in the last two years. The estimated amount filled is 120 million. At approximately $70 per prescription, that means more than $8 billion worth of Darvocet has been sold. It is recommended by the FDA that anybody currently taking Darvocet meet with a health care provider over it. Continue taking the drug until after you've spoken with your doctor.

Citations

LA Times

latimes.com/news/nationworld/nation/sc-dc-1120-fda-darvon-web-20101119,0,6525838.story

Wall Street Journal

online.wsj.com/article/SB10001424052748704170404575624580619320348.html

YubaNet

yubanet.com/opinions/Dr-Sidney-Wolfe-Delayed-FDA-Removal-of-Painkiller-Propoxyphene-Darvon-Darvocet-From-U-S-Market-Has-Cost-More-Than-1-000-U-S-Lives.php



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