Xanodyne Pharmaceuticals Inc. manufacturer of drug Darvon and Darvocet (brand name drugs) containing propoxyphene (a drug used for reliving pain ) and its all generic versions are all set to withdraw the drug from the U.S. market after the request from the U.S. Food and Drug Administration. Xanodyne Pharmaceuticals Inc and manufacturers of generic versions of propoxyphene containing drugs are also been informed to withdrawal of their respective drugs voluntarily from us market by The US FDA.
Why the drugs containg propoxyphene are being withdrawen from US market.
Propoxyphene (Dextropropoxyphene) is an opoid analgesic which was being used to treat mild to moderate pain, it was observed that patients taking drug were at high risk of getting potentially serious cardiac events, like fatal heart rhythm abnormalities, even at a regular recommended doses of propoxyphene brings about significant changes in the electrical activity of the heart. These changes, are reflected well in an electrocardiogram (ECG), these changes in electrical activity of heart increases the risk of serious and abnormal heart rhythms which are linked to serious adverse effects, including sudden death, even the patients taking drug for many years are subjected to the change in cardiac electrical activity with small change in the heath condition, like dehydration , a change in other medications and decreased renal function.
Propoxyphene is also known to cause dependency in users.
Looking at these facts in July 2009 the US FDA had asked Xanodyne Pharmaceuticals Inc to conduct additional safety studies besides the clinical trial data which was already submitted at the time of approval .
After reviewing these post market afety studies the US FDA has concluded that the beneficial effects of drugs containing Propoxyphene do not overweigh the risks of developing serious cardiac events, heart rhythm and abnormalities. As a result of review of the data, combined with other information, including new epidemiological data US FDA has asked to remove these drugs from US market.
Drugs containg propoxyphene were approved fist in 1957 by US FDA as a prescription.It was also combined with aspirin and acetaminophen (paracetamol).
US FDA has also advised health care professionals for not to prescribe drugs containing propoxyphene , the patients taking drug propoxyphene should contact their doctor /health care professional as soon as possible for changing the drug with other pain reliving drugs in for their therapy. How ever these effect are not cumulative, and are subsidized after discontinuation of the drug.
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