Potentially Dangerous Drug Darvocet Gets Black Box Warning

July 7, 2009
By Gabriel Mejia, Esq. on July 7, 2009 4:31 PM | | Comments (0)

The U.S. Food and Drug Administration (FDA) announced today that it will require manufacturers of drugs containing propoxyphene, such as Darvocet and Darvon, to include boxed warnings on their products which emphasize the risk of death and injury from overdose associated with the drug. This action comes after a British study and other data linked propoxyphene and fatal overdoses. The FDA is also requiring that manufacturers provide information with the drug stressing the importance of taking the medication as directed.

According to reports, the FDA refused to order a phased withdrawal of the potentially fatal drug from the market, despite an advisory panel's decision in favor of removing the product from circulation. Rather, the FDA decided to require further safety studies of the product to determine the effects of propoxyphene at higher than recommended doses.

Critics of the drugs argue that propoxyphene, a member of the group of drugs known as opioids and used to treat mild to moderate pain, poses a greater risk of addiction and fatal overdose than warranted by its arguable benefits. An estimated 21 millions prescriptions for propoxyphene-containing drugs were written in 2007 and reports indicate that 503 deaths were associated with the drug Darvon including 20% from suicides.

Gabriel Mejia is a Coral Springs personal injury attorney handling accident and injury cases in Florida for Law Offices Cytryn and Velazquez, P.A.

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