The Darvon Recall—What Took So Long?

December 8th, 2010. By janem

Darvon is over 50 years old—long enough to do some serious damage. Reports of adverse events, such as destroying people’s lives, were pouring in since 1979—back in the day when Ralph Nader was banging on FDA’s door to ban the painkiller, when Darvon was cited in 589 overdose deaths in 23 US cities. Nader’s Health Research Group called Darvon the “deadliest prescription drug in the United States” and Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group, said “Propoxyphene [Darvon] has one of the worst benefit-to-risk ratios I have ever seen for a drug,” yet the FDA did nothing.

What took the feds so long to recall Darvon and its evil cousin Darvocet? Rather than a recall, FDA just required that the manufacturer conduct an “educational campaign” to limit Darvon’s use. As if that would do any good: pharmaceutical companies aren’t educators, they are profiteers. Why didn’t the FDA slap a black box warning on the drug in ’79? I wonder if any of those decision-makers have any pangs of guilt, knowing how many OD’s they could have prevented. And now Darvon side effects have become as serious as a heart attack.

It wasn’t until a recent study confirmed that Darvon and Darvocet were associated with heart problems that the meds were yanked from North America’s shelves (the UK and other countries were way ahead—the UK started withdrawing Darvon in 2005 and again in 2009).

I think that one reason the FDA sat on it laurels for so long was because up until a few years ago, most people were prescribed Darvon for depression and overdoses were regarded as accidental suicides. Nothing wrong with the drug, just the patient. Then it become popular as a pain killer; so popular that by 2009, 10 million people had been prescribed some form of Propoxyphene, either Darvon or Darvocet.

Guaranteed there will be a lot of lawsuits now. And perhaps those families who lost a loved one to an “accidental overdose” (like victims of the Fentanyl Patch) will also come forward.

Tags: darvocet, darvon, darvon_darvocet

This was posted on Wednesday, December 8th, 2010 at 6:40 pm and is filed under Emerging Issues . Feel free to respond, or trackback. Read our comments policy.