Hawaii Attorney General David Louie has filed a lawsuit against the manufacturers and distributors of prescription drug blood thinner Plavix. The lawsuit named pharmaceutical companies Bristol-Myers Squibb and Sanofi-Aventis in the filing.
Louie stated that a significant portion of Hawaii’s population has difficulty metabolizing the drug and that BMS and Sanofi marketed Plavix to work the same way as aspirin to prevent stroke or a heart attack. He also alleged that the pharmaceutical companies failed to disclose that the drug has diminished or no effect on patients of East Asian or Pacific Islander descent because they naturally metabolize the drug poorly. Use of the drug puts such patient groups at risk for gastrointestinal bleeding and other complications. The Attorney General has yet to report any deaths related to use of the drug.
Clopidogrel bisulfate, marketed under the brand name Plavix, is a prescription blood thinner approved by the FDA in 1998 for the treatment of patients with peripheral arterial disease, heart disease related chest pains, heart attacks, and strokes. The drug is also indicated to lower risk of patients experiencing cardiovascular events such as potentially life threatening blood clots. Plavix requires a specific liver enzyme to break it down. But the FDA says 2 to 14% of people in the U.S. possess low levels of the enzyme and are prevented from successfully processing the drug. The FDA said the likelihood of being a non-responder to Plavix depends on race.
“Plavix is one of the most studied medicines with over a decade of real-world experience in patients with acute coronary syndrome, recent stroke, recent heart attack and peripheral arterial disease (PAD. Plavix has been prescribed to more than 115 million patients worldwide, including more than 50 million in the United States. …[The drug’s] diminished effectiveness is especially prevalent among Hawaii consumers,” the lawsuit stated.
Louie is the fifth state attorney general to file a lawsuit against Plavix claiming unfair and deceptive marketing, following Louisiana, West Virginia, Mississippi, and California. The companies said they won’t comment on the pending litigation.