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Free & Goss Attorneys

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The Food & Drug Administration has pulled a popular painkiller, which has been on the market for more than half a century, because of serious heart risks, the New York Times reported.

Medical malpractice lawyers frequently report on the health risks associated with dangerous or defective pharmaceuticals. As was the case with the controversial diabetes drug Avandia, the government has known of complaints regarding propoxyphene for years. Sold under the Darvon and Darvocet brands, the painkiller is used by 10 million Americans each year.

Only now is the government taking action –ending 32 years of dispute over the drug, which has been on the market for 53 years. The FDA is urging doctors to switch patients to alternative painkillers, specifically Extra Strength Tylenol or acetaminophen.

Not only has Propoxphene been shown to have very little effect on pain, it has a narrow margin of safety between the recommended dose and a harmful or fatal dose. Still, despite being an addictive opioid, it was the 38th-most prescribed generic drug last year, with 17.5 million prescriptions written.

Sales had declined last year amid renewed safety concerns. But it had remained popular in the United States, despite actions taken by consumer safety agencies oversees amid widespread evidence of the health hazards.

It was banned in Britain in 2005 and by the European Union last year. Those bans were based partly on deaths reported in Florida, where medical examiners do more toxicology work.

The FDA voted 14 to 12 to ban the drug nearly two years ago. It had first considered banning the drug in 1978.

Dr. Sidney M. Wolfe, of the Health Research Group of Public Citizen, which petitioned for the drug’s ban, told the Times that the FDA’s delay was inexcusable.

“I would have praised them if they had done this six years ago,” Dr. Wolfe said, “but it’s hard to praise them when there have been 120 million more prescriptions filled since 2005 and conservatively 1,000 to 2,000 more deaths. It’s inexcusable.”

An increasing number of cases involving dangerous pharmaceuticals has made it clear that neither drug companies nor government regulators can be relied upon to safeguard the public in a timely manner. Consulting an experienced law firm is the best course of action to protect you and your family in cases where a dangerous drug is suspected of causing the serious injury or death of a patient.