Darvon ban
From Drug Rehab Wiki
In November 2010, the FDA banned both Darvon and Darvocet and their generic forms because of their ability to create serious, even fatal heart trouble. The ban comes after years of scrutiny of the medication.
Originally released in 1957, propoxyphene was marketed under the names of Darvon and Darvocet. Darvon contains the drug in its true form, while Darvocet contains the additive, acetaminophen. Both drugs are manufactured by Xanodyne Pharmaceutical, Inc. Propoxyphene is part of the opioid family of painkillers that works by binding opioid receptors in the nervous system and GI tract.
The FDA has had two requests to take the drug off the market since 1978. Up until 2009, however, the organization felt that the benefits outweighed the possible health risks. After a meeting in January 2009, though, the FDA mandated that the potentially deadly side effects be made known to public via a warning on the label. The agency also ordered that Xanodyne conduct further studies into the harmful side effects of the drug.
Upon reviewing the results of the study, the FDA decided to prohibit the drug entirely. Results showed that, even when taken as directed in normal doses, propoxyphene alters electrical activity of the heart, which could cause a perfectly healthy person to drop dead. Other factors could contribute to damage, too. Even those who have taken the drug for a prolonged period of time were at risk because subtle variances in their health such as dehydration or a change of medications increased the risk of side effects.
Public reaction to the ban has been mixed. Some experts argue that the bar has been too long in coming. In fact, the drug has already been outlawed in many areas overseas – it has been six years since Great Britain called for its removal while the rest of Europe took it off the market over a year ago.
Sidney Wolfe, who works for Public Citizen’s Health Research Group says that the FDA is partially responsible for the more than 1000 deaths that have occurred as a result of drug because it failed to act after the UK banned it. Still others such as Diane Zuckerman of the National Research Center for Women and Families are praising the FDA’s concern for public health and thanking it for intervening.
