Sanofi-aventis, originator and manufacturer of Plavix and Iscover (clopidogrel hydrogen sulfate) confirms that all its clopidogrel-containing products, including Plavix and Iscover, are in full conformity with EMA requirements and are not concerned by the recall recommended by the European Medicines Agency (EMA) of certain generic clopidogrel products (clopidogrel besylate) in Europe. Iscover is marketed by Bristol-Myers Squibb Company in certain EU markets.
Sanofi-aventis manufactures all of its clopidogrel-containing products for the European markets in the European Union in full compliance with the relevant rules and regulations in force, including Good Manufacturing Practices (GMP). Plavix, Iscover and Clopidogrel Winthrop contain a clopidogrel hydrogen sulfate salt and are manufactured by sanofi-aventis in its GMP compliant sites (Sisteron, Neuville, Ambarès and Quétigny – France, and Fawdon - UK). Trombex equally contains a clopidogrel hydrogen sulfate salt, sourced from sanofi-aventis' GMP compliant manufacturing sites at Hlohovec (Slovakia).
Plavix (clopidogrel hydrogen sulfate) has been on the market for more than a decade. Clopidogrel is a lifesaving medicine indicated for a broad range of atherothrombosis patients: ACS (STEMI, NSTEMI, UA, with or without stent), recent MI, recent stroke, and established PAD. Plavix has an established efficacy and safety profile in the prevention of atherothrombotic events. It has been extensively studied in 4 large clinical trials involving more than 80,000 patients and prescribed to over 100 million patients worldwide. Throughout this period no quality related recalls have occurred.
Plavix is recommended daily for patients who have had a recent heart attack or stroke, or poor circulation in the legs that may cause pain during exercise, such as walking, and may be relieved by rest (known as peripheral artery disease, or P.A.D.).