Food and Drug Administration Bans Darvon and Darvocet

Darvon and Darvocet brand and generic drugs containing propoxyphene were banned today by the Food and Drug Administration in the US because of serious safety concerns. The UK banned the drugs previously in 2005.
Serious heart-related Darvocet side effects have been demonstrated in healthy people taking these drugs. It is estimated that over ten million Americans take Darvon, Darvocet and other compounds containing prophoxyphene. Propoxyphene-based drugs are analgesics in the opioid category, used to relieve mild to moderate pain and are additionally an anti-tussive and local anesthetic.

Doctors Recommend Against Quick Darvocet Withdrawal

Because of the possible danger of acute withdrawal symptoms, many doctors warn patients not to suddenly stop taking the drug, preferably weaning away from it gradually. Dr. Gerald Dal Pan, MD, MHS, director of the FDA office of surveillance and epidemiology says that patients in the United States should return to their doctors to find different pain relief medications.

Public Citizen, a public interest group, had attempted to have the drug banned in 1978 and again in 2006. Ultimately the FDA took the matter to an advisory committee of their experts who voted 14-12 to ban darvocet; but rather than banning the drug outright they chose to do more studies of the drug’s effect on the heart. In the end, the results of these studies led to the ban.

Risk for potentially critical (or even fatal) heart rhythm abnormalities with Darvocet

John Jenkins, MD is the director of FDA’s office of new drugs. He says that propoxyphene-based drugs put patients at risk of potentially serious or even fatal heart rhythm abnormalities. Public Citizen condemns the FDA, saying that the ban comes too late. They say that if the drug had been banned sooner, at least 2,000 more people not have died. Dr. Jenkins is not so sure; he asserts that it’s not that easy to determine exactly how many people have died because of the darvocet side effects.
However according to Dr. Del Pan, the effectives of the drug are not cumulative. “In other words, the side effects of darvon and darvocet will wear off if you stop taking the drug."
Make sure you keep checking back here, as this story has not yet been fully told. There’s sure to be more information yet to be revealed.