FDA Panel Recommends Darvocet & Darvon Recall
February 2009 – An advisory committee to the U.S. Food and Drug Administration (FDA) has recommended that the FDA recall Darvon, a popular painkiller also sold in combination with acetaminophen under the brand name Darvocet.
The FDA panel recommended a recall after it concluded that the substantial risk of life-threatening side effects with Darvon and Darvocet, which include addiction, overdose and suicide, far outweigh the benefits of the drugs. While the FDA is not required to follow the advisory panel’s advice and issue a Darvon and Darvocet recall, the FDA usually complies with their advisory panel’s recommendations.
Darvon and Darvocet are prescription narcotics containing the chemical propoxyphene. Approved by the FDA to treat mild to moderate pain, Darvon and Darvocet are often prescribed to manage post-surgical pain.
The FDA advisory panel initiated its investigation into the safety of Darvon and Darvocet in response to a petition by the consumer advocacy group Public Citizen, which requested that a Darvon and Darvocet recall be issued to phase the drugs off the market. Public Citizen’s petition, which was originally filed with the FDA in February 2006, indicates that more than 2,000 accidental deaths have been linked to Darvon and Darvocet since 1981. The recall petition also points out that Darvon and Darvocet are physically addictive and are no more effective than other safer painkillers, like ibuprofen and acetaminophen.
In 2008, Public Citizen filed a lawsuit against the FDA alleging that the agency was violating the law by failing to act on the Darvon and Darvocet recall petition filed in 2006. According to data collected by the FDA for the hearing, the FDA has received more than 3,000 reports of serious problems with Darvon and Darvocet, with most involving suicides, addiction and overdoses.
Darvon & Darvocet FDA Recall Attorney
If you or a loved one have taken Darvon or Darvocet and suffered a serious side effect, such as overdose, suicide, or addiction, you may be entitled to compensation for your injuries. Contact our Darvon and Darvocet recall attorneys for a free and confidential case evaluation today!
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