subject: Darvocet Recall Makes Lawsuits Against Drugmakers Likely [print this page] Darvocet Recall Makes Lawsuits Against Drugmakers Likely
If you are one of the 10 million patients currently prescribed the painkiller propoxyphene, then you are probably shocked, or at the very least concerned, by the recent news that the FDA is requesting a market withdrawal of the drug. Propoxyphene is best known as the brand name pain relievers Darvon and Darvocet and has been available since 1957 when the FDA approved Darvon, then made by Eli Lilly & Company. Today, Darvon and Darvocet are made by Xanodyne Pharmaceuticals, Inc., and propoxyphene is additionally available under many other brand and generic names, including Dolene, Trycet, Wygesic, Genagesic, Propacet, and Balacet.
The FDA's decision to issue a Darvon recall for the U.S. market was prompted by new research, conducted by Xanodyne, that indicates the drug causes potentially fatal heart problems. When determining the safety of a drug, the FDA uses a relative measure whereby a drug's risks are measured against its benefits. After reviewing the results of the Xanodyne study, the FDA concluded that, "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."
But while the new study provides conclusive evidence that propoxyphene is dangerous, it's safety has been in question for years. The non-profit consumer advocacy group Public Citizen petitioned for the drug to be banned twice, first in 1978 and again in 2006, arguing that it had a thin margin of safety and was responsible for thousands of deaths. Although unable to achieve a propoxyphene ban during either of its campaigns, the group's most recent effort resulted in the FDA updating product labeling for the drug in 2009 to include a stronger overdose warning. In addition, the FDA, claiming it needed more information about propoxyphene's effects on the heart before taking more decisive action, ordered Xanodyne to conduct the research that uncovered the drug's deadly coronary side effects.
Total compliance with the FDA's Darvocet recall could take months, as Xanodyne is the only manufacturer to officially announce its compliance. Other drugmakers are expected to follow suit, however.
It also seems inevitable that in the coming months, many lawsuits will be filed against Xanodyne and the other makers of propoxyphene products. In fact, a class action suit has already been filed in New Orleans district court by a woman who claims Darvocet caused her to suffer two heart attacks. At this stage, it appears that patients who suffered a heart attack or stroke or who developed an arrythmia, atrial fibrillation, irregular heartbeat or other cardiac symptoms while taking propoxyphene have grounds to file a lawsuit against the drug's manufacturer.
If you believe that propoxyphene caused you or a loved one's heart complications, visit your doctor as soon as possible. The FDA has stated that patient risk is eliminated when they stop taking the drug, but you will need to speak to your health care provider about switching to an alternate pain medication, whether another opiod such as codeine or a non-narcotic such as Tylenol or Ibuprofen.
Those who meet the above criteria for a Darvon lawsuit should also consider meeting with an attorney to discuss filing a claim. In the event that propoxyphene did cause your injuries, the drug's manufacturer by law is obligated to compensate you for any resulting losses. As time goes by and more claims are filed against Xanodyne and other companies, the way to proceed with a Darvon/Darvocet recall lawsuit will become clearer. In the meantime, it is in your interest to share all of the relevant facts surrounding your injury with an experienced attorney who can recommend the best course of action.
