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FDA Adds Black Box Warning to Painkillers Darvon and Darvocet Because of Risk of Fatal Overdose

By July 14, 2009July 17th, 2019Dangerous Drugs

The U.S. Food and Drug Administration has required the strongest warning label a drug can have for two painkillers, the Washington Post reported July 8. Darvon (propoxyphene) and Darvocet (propoxyphene with acetaminophen) got the increased warning, the agency said, to reduce the risk of fatal overdoses. The new label will warn patients about the risk of an overdose, and accompanying packaging will include a medication guide emphasizing the risks of not using the drug as directed. In addition, the FDA has ordered a new study of the effects of a propoxyphene overdose on the heart.
The agency’s action came a few weeks after the European Union’s drug regulator voted to phase out Darvon and Darvocet for safety reasons. In the U.S., the activist group Public Citizen petitioned in 2006 to take propoxyphene off the market, saying it is a relatively weak painkiller with too many side effects. In fact, an advisory panel for the FDA voted in 14 to 12 January that the drug should be withdrawn from the U.S. marketplace. The FDA decided not to follow its panel’s advice (which it is free to do) saying the benefits of the drugs outweighed the risks.
According to the Post, the problem with propoxyphene is its effect on the heart. Propoxyphene can decrease the patient’s heart rate and raises the risk of a potentially fatal heart arrhythmia, which has led to fatal overdoses. Because it is also a weak opioid painkiller with potential for addiction, watchdogs may be concerned about its potential for overdoses among drug abusers. The FDA has recorded 91 cases of fatal overdose since 1969, but overdoses are widely thought to be underreported. In the form of Darvocet, which combines propoxyphene with acetaminophen, overdose also carries the risk of fatal liver poisoning.
Darvon has been on the U.S. market since 1957 — and that’s what concerns me, as a dangerous prescription drug attorney. Though it’s not nearly as popular as prescription painkillers like Vicodin, propoxyphene is prescribed about 22 million times a year. Even if only a tiny fraction of patients overdose each year, that’s a huge number of people over the decades who may have been killed by a drug they trusted to help them. That means the pharmaceutical companies that make and sell Darvon and Darvocet could face thousands of pharmaceutical injury lawsuits from the families of people who were wrongfully killed.

Based in St. Louis and Belleville, Ill., the Lowe Law Firm represents people from around the United States who were seriously injured by a pharmaceutical product that was supposed to help. Our defective drug lawyers hold drug companies legally responsible for making and selling products with serious safety flaws, or marketing products in a way that hides their serious risks. In a lawsuit, victims of pharmaceutical injuries can win compensation for the costs, injuries, illnesses, pain and disabilities that the drug caused for them, including the wrongful death of a loved one.
If you or a loved one developed serious side effects after taking a prescription drug, Carey, Danis & Lowe would like to help. To learn more at a free, confidential consultation, please contact us online or call us toll-free at 1-877-678-3400.