FDA Approves Generic Version of Blood Thinning Drug, Plavix, Despite Serious Side Effects
May 21st, 2012 tmccoy
Recently the U.S. Food and Drug Administration (“FDA”) for the first time a
Plavix is a blood thinner prescribed for the prevention of blood clots, and is often the preferred treatment for patients particularly at risk of suffering a stroke or heart attack. The drug has been linked to serious side effects, including gastrointestinal bleeding, bleeding ulcers, thrombotic thrombocytopenic purpura (TTP) and cerebral hemorrhages.
pproved for domestic sale the generic version of ultra-popular blood thinning drug Plavix.
Brand-name Plavix is marketed jointly by Bristol-Myers Squibb Co. (“BMS”) and Sanofi SA (“SS”). Prior to the FDA’s approval of the generic version, BMS and SS were enjoying nearly $9 billion in annual revenue from the sale of Plavix, which ranks as the second most popular drug in the U.S. These exorbitant sales figures come as no surprise when you consider that Plavix accounts for close to half of all prescription drug sales globally.
All in all, the FDA granted generic approval to seven companies: Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals. Additionally, Dr. Reddy’s Laboratories and Gate Pharmaceuticals may sell a 300-milligram dose, which is given almost primarily as an emergency treatment for heart attack patients.
In an attempt to retain their pre-generic clientele, BMS and SS are offering Plavix coupons that greatly reduce the otherwise $200 per month cost of the brand-name version. Additionally, Plavix users may sign up for the Plavix Choice Card, which will allow them to secure a 30 day supply each month for the remainder of the year for a total cost of $37 per month.
Nevertheless, with generic forms of Plavix soon to flood the market, BMS and SS will surely see Plavix prescription rates drop.
