An FDA panel, citing safety risks, voted Jan. 30 to remove a pair of painkillers from pharmacy shelves. According to the Associated Press, the panel of outside experts voted to end sales of Davron and Davrocet because of concerns that their safety risks outweigh their benefits. The FDA is not bound by the decision, but it frequently follows the recommendations of its outside panels.
Davron (propoxyphene) is a opioid painkiller used for mild to moderate pain. Davrocet is a combination of Davron and acetaminophen, the active ingredient in Tylenol, and is now more frequently prescribed then Davron alone. Like all opioids, both drugs carry a high potential for addiction and abuse and are not safe when combined with alcohol. They have also been linked with serious health problems, including heart problems, respiratory disorders and kidney and liver problems. And in the 1970s, studies linked the drug with suicide, prompting an unsuccessful drug recall campaign from watchdog group Public Citizen. Complaints from the same group spurred the current review.
Davron has been on the market since the 1950s and is now among the 25 most commonly prescribed drugs in America, with 20 million prescriptions written in 2007. However, because it is a relatively weak painkiller competing in a field that includes newer, stronger drugs, experts are concerned that its risks are now greater than its benefits. A limited federal study showed about 500 Davron-related deaths in 2007; 20% of these were suicides. In Florida, medical examiners found Davron in the bodies of 341 people who died of any cause and cited it as the cause of death in 85 cases (about a quarter of the total). The British version of the drug was banned outright in 2005.
The FDA may not take such a drastic step; it could choose to strengthen the warnings on Davron’s label or further restrict its use. However, the controversy over this drug dates back more than 30 years — making its risks older than some of the patients taking it. As a Missouri defective drug lawyer, I know that the FDA is currently very reluctant to recall prescription medications, sometimes even when there’s strong evidence that they have serious defects. However, when the doubts about a drug have persisted for so long, it may be time for serious action. Thanks to advancements in medical science, doctors now have a variety of safer or more effective drugs to replace it with.
If it turns out that Davron has been putting patients at serious risk of suicide, heart problems and other serious side effects for decades, its manufacturers could be legally liable to thousands or even millions of families in a defective prescription drug lawsuit. If you believe you or someone you love was hurt by Davron, Davrocet or another potentially dangerous medication, Carey, Danis & Lowe can help. Based in St. Louis, we help clients in Missouri and throughout the nation who have lost a loved one or sustained permanent injuries because of a drug company’s carelessness.
To learn more about your rights at a free consultation, please contact the Lowe Law Firm online today or call toll-free at 1-877-678-3400.
