Medications Linked to Increased Risk of Heart Rhythm Abnormalities
In November 2010, Xanodyne Pharmaceuticals Inc. voluntarily pulled two of its popular prescription pain medications from the market - Darvon and Darvocet. The Food and Drug Administration (FDA) requested the pharmaceutical company recall the medications in light of a recent study showing that individuals who use propoxyphene are at risk of developing potentially life-threatening heart rhythm abnormalities.
Darvon is the brand-name for propoxyphene (an opioid used to treat patients with mild to moderate pain and commonly prescribed to treat arthritis, among other conditions). Darvocet contains propoxyphene as well as acetaminophen (Tylenol). Since 2009, an estimated 10 million Americans have been prescribed Darvon, Darvocet or a generic version of propoxyphene.
The FDA requested removal of any drug containing propoxyphene from the market after the results of a trial study revealed that the drug has an adverse effect on heart rhythms. The study (conducted by Xanodyne Pharmaceuticals) revealed that even when patients take the recommended doses of propoxyphene, patients still have an increased risk of suffering heart arrhythmia, heart attacks and other serious side effects from the drug.
The study also found that small changes to a patient's health could increase the patient's risk of suffering adverse cardiac events. For example, dehydration, change in medications and/or a change in kidney function can all impact how the patient metabolizes the drug.
According to the study, the effects of propoxyphene are not cumulative, so once patients stop using the drug, they are no longer at risk. Those who have used the drug for years do not have a higher risk of developing irregular heart rhythms than those who have used it for a much shorter period of time.
The FDA also requested manufacturers of the generic versions of propoxyphene voluntarily remove their drugs from the market. Additionally, the FDA has asked physicians to cease prescribing the medications to their patients. However, patients currently taking either one of the drugs or a generic version should contact their doctors before discontinuing use. Depending on how long individuals have been on the drug, they may experience withdrawal symptoms if they discontinue the medication immediately.
Earlier Attempts to Remove Propoxyphene
The FDA first approved Propoxyphene for consumer use in 1957. Since then, several attempts have been made to take medications containing the drug off market shelves. Public Citizen, a non-profit public interest group, tried unsuccessfully to remove propoxyphene from the market. In 2006, the group pressured removal due to the risks of accidental overdose. Public Citizen estimates that more than 2100 people died from accidental overdose of the drug from 1981 to 1999.
In January 2009, the FDA organized an advisory panel to determine whether propoxyphene should remain available to U.S. consumers. The panel voted 14 to 12 in favor of removal, but the FDA chose to ignore the advisory opinion. Instead, in July 2009 the FDA said propoxyphene could remain on U.S. shelves so long as manufacturers included a black-box warning on the medication's packaging. The new warning alerted patients to the danger of overdose if patients took the medication in high doses, combined the drug with other medications, or took it longer or more often than prescribed by their physicians.
In 2009, the FDA also asked Xanodyne Pharmaceuticals to conduct a study on the potential cardiac risks of propoxyphene - the study that ultimately led to pulling Darvon and Darvocet from the market.
Conclusion
Those who suffered adverse effects after using Darvon, Darvocet or a generic version of propoxyphene, may be entitled to compensation. For more information, contacting an experienced drug recall attorney is advised.
