Posted On: February 2, 2009 by Michael A. DeMayo

Ban Painkiller Darvon, Says Food and Drug Administration Advisory Panel

In a 14-12 vote, an advisory panel for the Food and Drug Administration is recommending a ban on the prescription drug Darvon. The painkiller has been used for over 50 years.

First approved in 1957, Darvon is one of the 25 most commonly prescribed medicines. It is primarily marketed these days as Darvocet. In 2007, over 20 million prescriptions for this drug were issued.

Public Citizen, a consumer group, had asked the FDA to withdraw the Drug because its risk of overdose is so high and the amount of pain relief it actually offers is low.

The drug is marketed by Qualitest/Vintage Pharmaceuticals and Xanodyne Pharmaceuticals. Both companies maintain that the drug is effective and safe when used correctly. They also claim that there are other painkillers where the abuse risks and known consequences are far worse.

The FDA’s safety office says it found over 3,000 reports linking Darvon to serious problems, including suicide, drug overdose, and drug dependence. The office said that its findings, however, are “insufficient” for reviewers to make a decisive recommendation. Meantime, the FDA office in charge of handling painkillers says Darvon is a weak pain reliever.

Information from the US government’s Drug Abuse Warning Network found that there were 446 Darvon-related deaths in 2006 and 503 deaths in 2007. 20% of these fatalities were suicides. These figures only referred to about 30% of the country’s population.

Dangerous Drugs
Prescription drugs are not supposed to cause dangerous side effects—although the FDA is known for approving drugs that do have such side effects, as long as they don’t happen too often. Drug manufacturers and doctors are supposed to warn users of potential health complications that can arise from any prescription medications.

Sometimes, a dangerous drug is allowed to enter the marketplace. When injuries or deaths arise as a result of a dangerous drug, the victim and his or family may have grounds to file a dangerous drug lawsuit.

FDA panel recommends ban on the painkiller Darvon, Boston.com, January 30, 2009

Darvon, Drugs.com

Related Web Resources:
Petition to FDA to ban all propoxyphene (DARVON) products; prescription painkiller causes many fatalities (HRG Publication #1762), Public Citizen, February 28, 2006

Read the FDA Advisory Committee's Briefing, January 30, 2009 (PDF)

Drug Abuse Warning Network

If you believe that you were a victim of a dangerous drug, please call our North Carolina drug litigation lawyers at the Law Offices of Michael A DeMayo today.

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