The FDA says the drug, propoxyphene, puts patients at risk of potentially serious or fatal heart rhythm abnormalities. Since , 10 million people have been prescribed some form of the drug.
As for patients, do not stop taking it, but we urge you to contact your health care professional. Xanodyne Pharmaceuticals Inc. It is sold under various names as a single-ingredient product e. The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval.
These changes, which can be seen on an electrocardiogram ECG , can increase the risk for serious abnormal heart rhythms. FDA has concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. In July , FDA announced an ongoing safety review of propoxyphene, which included evaluating its potential effects on the heart. Dispose of unused propoxyphene in your household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines:.
Additional Information for Healthcare Professionals. Following receipt of a Citizen Petition requesting the withdrawal of propoxyphene-containing products from the United States market, FDA convened an Advisory Committee meeting on January 30, After presentations by FDA, the petitioner, and the company reviewing the efficacy and safety data from the propoxyphene drug applications, the literature and postmarketing safety databases, the committee voted by a narrow margin to against the continued marketing of propoxyphene products.
Those who voted for propoxyphene to remain on the market advised requiring improved labeling, particularly with warnings about use in elderly patients and about use with concomitant opioids or alcohol. Finally, there was general agreement that additional information about the cardiac effects of propoxyphene would be relevant in further weighing the risk and benefit.
In order to determine a safe supratherapeutic dose to incorporate into the Thorough QT study, FDA required the drug manufacturer to first conduct a multiple-ascending dose MAD study. Propoxyphene-containing drugs have been banned in Great Britain since The European Medicines Agency in June recommended their gradual removal from the European Union market after concluding risks, including the risk of fatal overdose, outweighed pain-relieving benefits.
The FDA called upon the pharmaceutical companies to stop making propoxyphene PPX based upon a clinical trial in which electrocardiograms demonstrated that the drug altered the heart's electrical activity, potentially causing serious or life-threatening arrhythmias. Gerald J. Dal Pan, director of CDER's Office of Surveillance and Epidemiology, said that with the new results, "for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart.
Dal Pan said that the cardiac changes aren't cumulative and that "once patients stop taking propoxyphene, the risk will go away. About 10 million Americans took a prescription containing propoxyphene for mild to moderate pain in , the FDA said.
That same year, the agency announced an ongoing safety review of the drug. Darvon, developed by Eli Lilly and Co. It is a little difficult to find out more exact information since the study is not published but lets do a little Scooby Doo-like sleuthing. Propoxyphene is a synthetic derivative of methadone. Methadone causes QT prolongation of questionable clinical significance in palliative care patients.
QT prolongation is a risk factor for ventricular arrhythmias. Never heard of that before? Well all new drugs since have had to pass through one before being approved. Given this increased risk of QT prolongation and the fear of resulting ventricular arrhythmias, the risk of the drug started to overwhelm the very minimal benefit it offered.
Here is a quote from the memo: emphasis mine At the advisory committee meeting, FDA staff shared postmarket data that have been suggestive, but inconclusive, about the risk for propoxyphene-related cardiac toxicity when used at therapeutic doses. No cases of torsades de pointes TdP causally associated with propoxyphene have been reported despite extensive use for many years.
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