Pharmaceutical companies continue to take advantage of the uncertainty surrounding the safety of Pradaxa, as nine companies have gained approval to create the generic version of the blood thinning drug Plavix.
The Food and Drug Administration recently approved the use of clopidogrel, which helps reduce the risk of heart attack and stroke by thinning the blood so platelets do not clump and form clots in the arteries, to treat patients who have suffered a heart attack, stroke, or have partial or total blockage of an artery.
Four pharmaceutical manufacturers - Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals - have gained FDA approval to create 300 milligram doses of clopidogrel. Five other manufacturers - Apotex Corporation, Aurobindo Pharma, Roxane Laboratories, Sun Pharma, and Torrent Pharmaceuticals - have been approved for 75 mg doses.
“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” said Dr. Keith Webber, the deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “The generic products approved today will expand those options for patients.”
Every introduction of a new anticoagulant drug to the market, it cannot be ignored that Pradaxa was once anticipated to be the new golden standard for blood thinner medication and replace warfarin as the one most commonly used in hospitals. However, the drug’s reputation has been marred by numerous reports of deadly bleeding events that have been associated with it.