The United States Food and Drug Administration (FDA) issued a massive request last month when it requested that the manufacturers of propoxyphene, known as PXP, a pain reliever, to stop selling drugs that contain PXP. PXP was introduced in 1957 under the trade name of Darvon. Derivatives of Darvon, including Darvon Compound and Darvocet, quickly followed and added other analgesics to the parent drug. When the product recall occurred, an estimated 10 million Americans took drugs containing PXP. Alone, PXP was not very effective in pain-relief and seemed to have an addictive risk.
The Darvocet product recall came after reports that PXP could cause dangerous disturbances in heart rhythm. Individuals critical of PXP have argued for over 20 years that the recalled drug was unsafe for many reasons. The FDA vote was 14-12, reflecting the controversy surrounding the issue. The United Kingdom and the European Union had already banned PXP sales several years prior to the recall. PXP is not the only recently recalled drug with suspected cardiac side effects. In September 2004, Vioxx was recalled based upon heart problems that appeared after 18 or more months of use of the drug. This product recall was despite a spirited defense by its manufacture that the drug was safe. And since that, the FDA has issued new warnings of cardiac risks associated with diabetes drug Avandia. Again, the panel reviewing the dangers of Avandia was deeply divided over whether to withdraw or restrict use of the agent.
While the FDA conducts extensive review of all laboratory and clinical studies to assess the safety of new drugs, the agency depends on the integrity of scientists who conducted the original studies. The FDA unfortunately does not have the capacity to test new drugs independently. The agency must consider other options to review drugs and avoid subsequent product recalls.
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