Darvon and Darvocet: Too Risky to Prescribe?
Public Citizen, a consumer advocacy group, has recently sued the FDA over the organization's failure to respond to a petition addressing the risks of prescribing Darvon, Darvocet, and other medications containing propoxyphene. Public Citizen filed a lawsuit in the U.S. District Court in Washington, DC alleging the FDA's failure to respond to their petition to ban the drug within the six months mandated by law.
Darvon and Darvocet both contain propoxyphene and are used as painkillers. Public Citizen noted numerous medical studies supporting the theory that these drugs pose a danger as long as they remain on the market. The petition was filed February 28, 2006, but the FDA has not yet issued a decision regarding the removal of the drug from the market.
Darvon and Darvocet have been linked to over 2,000 deaths since 1981 and have recently been banned in the United Kingdom because of the number of accidental deaths and suicides associated with propoxyphene use. Despite the risks, propoxyphene is one of the most commonly prescribed generic drugs. Over 22 million prescriptions for drugs containing propoxyphene were written in 2007.
According to Public Citizen, propoxyphene is habit forming and may cause drowsiness and dizziness. The organization points to studies which have shown that Darvocet, a propoxyphene-acetaminophen compound, is no more effective in relieving pain than acetaminophen alone, yet poses a higher risk for dangerous complications and side effects.
Public Citizen is asking the court to rule the FDA's delay unlawful and order the FDA to issue a decision on the petition.
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