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Darvocet & Darvon Pulled by FDA – Why?

Posted Nov 20 2010 3:00pm

The FDA sought the withdrawal after receiving new data showing that the drug put patients at risk for potentially fatal heart rhythm abnormalities, the agency said. “These new heart data significantly alter propoxyphene’s risk-benefit profile,” the FDA’s John Jenkins said in a statement. “The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”
Source: washingtonpost.com/wp-dyn/content/article/2010/11/19/AR2010111906786.html

Darvon and Darvocet are not uncommonly used pain medications. Patients with side effect issues with Vicodin are put on it pretty commonly. The key ingredient in both is propoxyphene, a relatively weak narcotic.

Apparently over the last few years studies in Europe have indicated potential heart arrhythmias. It was pulled in Great Britain six years ago. Should it have been pulled in the US sooner? I am sure lawyers looking to line their pockets with cash will be saying so. On the other hand, when you have a drug that has been on the market for such a long time, how much data do you need to pull it? That all depends upon the data and we are not looking at that data. I have never seen a patient develop an arrhythmia problem on it however.

Best Regards,

John Di Saia MD

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