The attorney general in Hawaii filed a lawsuit against the manufacturers of clopidogrel, claiming the companies deceptively marketed the antiplatelet drug by not disclosing its reduced efficacy in patients who are poor metabolizers.
The FDA placed a boxed warning on clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi Aventis) in 2010 to inform physicians that patients with impaired CYP2C19 function may not effectively metabolize the drug and therefore may not receive its anti-clotting benefits. The agency added that physicians should conduct genetic tests to identify poor metabolizers and recommended they consider other medications or dosing strategies in carriers of one or more reduced-function allele.
Attorney General David M. Louie claimed that between 38 percent and 79 percent of Pacific Islanders and 40 percent to 50 percent of East Asians are poor metabolizers. He argued that more than 1 million prescriptions for clopidogrel have been given for profits of more than $10 million since 1998.
He charged that Bristol-Myers Squibb and Sanofi Aventis “deceptively and unfairly” labeled and marketed clopidogrel and failed to disclose that genetic tests were available to identify poor metabolizers. In a statement, the attorney general wrote that these practices put Hawaiians at risk.
Louie is seeking civil penalties and the return of all profits made from clopidogrel sales in Hawaii.