FDA’s Negligence of Painkillers’ Side Effects Could Have Caused over 1,000 Deaths
Last Friday, national consumer advocacy group Public Citizen criticized FDA’s negligence about the dangerous side effects of Darvon.
Public Citizen first petitioned FDA for a recall of these painkillers in 1978 and again in 2006 after receiving concerns about the drug’s dangerous side effects. Evidence showed that risks outweighed the limited benefits. Darvon was shown to cause addiction and lead to toxin build-up in the heart. After FDA’s failure to act on the petition to pull the drugs from the market, Public Citizen filed a lawsuit against FDA in 2008.
The FDA did not recall the painkillers until last week, claiming that the agency didn’t receive enough evidence to justify the risks of these drugs until recently. FDA received data the the drugs were associated with heart arrhythmia, which could cause death. The UK banned Darvon and Darvocet in 2005 and Europe banned the drugs a year ago. Public Citizen believes FDA’s delay in recalling the drugs have caused over 1,000-2000 deaths in the US since the ban in the UK.
Darvon has been around for more than 50 years, and since its first introduction to the US in 1957, it has been used as a painkiller for post-surgical pain. More than 22 million people have been prescribed Darvocet, which is currently the most popular form of Darvon.
Dr. Sidney Wolfe, director of Public Citizen’s health research wing, stated that Public Citizen will try to start up an investigation to determine the responsible figures behind FDA’s delay in taking the painkillers off the market. In the meanwhile, product liability lawyers will be looking into the Darvon and Darvocet lawsuits for patients who have suffered injuries from the drugs.
According to Wolfe, the FDA “needed to order a human study to find that ‘the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities’ before deciding whether to ban [the drugs].” It’s mind-boggling to believe that FDA would neglect the serious consequences of these drugs for so many years when there have already been tens of thousands of cases of deaths and near-death. Sure, it is true that all pain medications have dangerous side effects, but is 50 years too long of a wait to realize the seriousness of the complications that arise from the drugs?
Source: Darvon, Darvocet Side Effects Needed Earlier Recall: Public Citizen
Photo Credit: Charles Williams
The FDA reviews a lot of data and rruqiees strong evidence before they will approve a drug for sale, but sometimes negative evidence does not become available until long after a drug is on the market. Some of these drugs may have been on the market for years, if not decades, and were grandfathered into an approved status and remained on the market until further data could be presented that was strong enough to support FDA taking action. This is the case with Darvon, Darvocet or propoxyphene- containing compounds. Propoxyphene is a drug that we, as consulting pharmacists, have known for a long time has risks that outweigh its benefits. That is why following the advice of a well-trained pharmacist is critical since there are other drugs on the market that we caution against using or that should be monitored more closely. Thanks again for your comments.