Darvon, Darvocet Recall Issued Due to Risk of Potentially Fatal Heart Rhythm Abnormalities
Last Updated on June 26, 2017
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At A Glance
- This Alert Affects
- Patients who have been prescribed Darvon, Darvocet, or generic propoxyphene-containing products.
- Damages
- Studies indicate that propoxyphene, even when taken at the recommended dosage, can increase the risk of abnormal heart rhythms, which have been linked to serious negative effects, including death. Past issues that have been linked to these medications include accidental overdose, suicide, nausea, and vomiting.
- Company(ies)
- Xanodyne Pharmaceuticals and the generic manufacturers of propoxyphene-containing products.
- Additional Details
- Darvon and Darvocet are brand names for propoxyphene, a prescription pain medication used to relieve mild to moderate pain.
- Date
- The Darvocet and Darvon recall was issued on November 19, 2010.
At the request of the FDA, Xanodyne Pharmaceuticals has agreed to issue a Darvon and Darvocet recall after a study indicated that the prescription pain medication puts patients at risk for serious or possibly fatal heart rhythm abnormalities. Manufacturers of generic propoxyphene-containing products have been informed of the recall and were also asked to voluntarily remove their products from the market.
Links to Abnormal Heart Rhythms
The FDA requested a recall of propoxyphene, which is marketed under the brand names Darvon and Darvocet, after reviewing data which revealed that, even when taken in proper doses, the drug significantly impacts the electrical activity of the heart. Since 1978, the FDA has received two previous requests to withdraw propoxyphene from the market; however, it did not issue a recall until November 2010. Until then, the FDA believed that the pain management benefits outweighed the side effects of Darvocet and Darvon.
The significant impact of the drugs on the heart can been seen using an electrocardiogram (ECG) and may increase the risk of dangerous and abnormal heart rhythms, which have been linked to serious adverse events, including sudden death. Other cardiac side effects of Darvon and Darvocet include the interruption of the heart’s transmission of electrical impulses, slowed heartbeats and a decrease in the heart’s ability to contract properly. Small changes in the patient’s heath, including medication changes, decreased kidney function, or dehydration, may impact a user’s risk of developing heart problems.
Suicide Risks
Heart problems are not the only dangerous side effects of propoxyphene. The FDA has received more than 3,000 reports of serious side effects, with most involving suicide, addiction or overdose. In July 2009, the FDA decided to place a black box warning on propoxyphene-containing products to highlight the risk ofsuicides, as well as accidental overdoses.
Darvocet and Darvon Recall Lawsuits
If you have experienced side effects of Darvocet, Darvon or the generic propoxyphene, you may be entitled to compensation in light of the recent recall.
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