Mesothelioma Legal Advice

It has recently come to light that the U.S. Food and Drugs Administration has sought manufacturers to voluntarily issue a Darvon recall and Darvocet recall. Darvon, which is also made available as Darvocet, is a medication containing the drug propoxyphene which was manufactured by Xanodyne Pharmaceuticals, Inc. Darvon, used to alleviate mild to moderate post-surgical pain, was first introduced in 1957.

Consumer advocacy group, Public Citizen, first filed an appeal to prohibit the use of the propoxyphene in 1978 but nevertheless, sales proved strong for Darvon and Darvocet. Likewise, another appeal was made by the organization in 2006 which was acted upon by the FDA by calling on an expert advisory committee in 2009 and has gotten a vote of 14-12 to ban the drug. Despite the ruling of the panel, the FDA decided to repeal the vote and requested Xanodyne to conduct a study that would see how propoxyphene affects the heart. Results of these tests prompted the FDA Darvon recall request.

An electrocardiogram (ECG) was used in the clinical trials that measured the heart’s activity. The electrical activities of the heart was discovered to be affected by propoxyphene, even when the prescribe dose was taken. Indicative of heart problems, the drug may be a cause for symptoms like decreased or difficulty breathing, convulsions, low blood pressure, decreased heart function and irregular heartbeat (arrythmia). Cardiac arrest and sudden death may be likely in the event of complications suddenly arising from the use of Darvocet.

“These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks,” said Dr. John Jenkins, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research (CDER).

Since the side effects of Darvon are not cumulative, individuals who have been taking the drug for a long period of time should not worry too much. Ending the use of the drug should make the symptoms go away but seeking the advice of your doctor is still important before trying another medication.

Millions are affected by the Darvon recall as the medication has been around for a long period of time and is often the popular choice drug. Further digging regarding the withdrawal of the product should be on your to-do list especially if you are one of those who have been taking the drug. Information is available in the Darvon Darvocet Recall Center.