FDA Requires Makers of Darvon, Darvacet, to Issue Strong Warnings

By Rachel Stockton

The death of Michael Jackson has spurred widespread speculation over whether or not any of Jackson’s private physicians will be charged with negligence or worse in the death of the superstar. According to CNN, Jackson consumed approximately 10,000 pills in six months.

Painkillers are also making headlines on other fronts. A special panel urged the FDA in January 2009 to ban Darvon and Darvacet, one of the top 25 of the most prescribed prescription medications. The drug contains the narcotic painkiller propoxyphene, which experts claim is similar to methadone.

Although the FDA usually complies with suggestions put forth by their own panels, in this case, they opted for a compromise. They are requiring that manufacturers of any painkiller containing propoxyphene provide a boxed warning to consumers. They have also asked the makers of this class of drug to provide detailed information on the toxicity of propoxyphene when abused.  

Critics of the drug maintain that it is weak to the point of ineffectiveness, which could potentially lead to abuse of the drug. They are concerned that patients will think that if 2 pills don’t work, they’ll try 5 instead.  

Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research defended the drug, stating that its side effects are milder than other narcotic painkillers, including codeine and hydrocodone.  

This is not the first time the federal government has been asked to ban Darvon, which was initially approved in 1957. In 1978, the Health Research Group, a consumer organization affiliated with Ralph Nadar, asked the Department of Health, Education and Welfare to either ban the drug, or at least restrict sales.  

Joseph Califano, the Secretary of the Department of Health, Education and Welfare at that time, declined to remove the drug from the market. However, in 1979, the makers of Darvon voluntarily agreed to provide warnings to patients on the hazards of abuse and of mixing the drug with alcohol. In 1980, the FDA asked physicians not to allow refills of the medication (New York Times).