Letter to the FDA Calling For Black Box Warnings for the Drug Vorapaxar as a Condition of Approval

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Public Citizen urged the Food and Drug Administration that if it decides to approve the drug vorapaxar, as a condition of approval the agency should require a black box warning in the drug’s label. The warning should indicate that patients with prior history of stroke or transient ischemic attack should not use the drug due to the risk of drug-induced strokes. The warning also should state that patients with a body weight of less than 60 kilograms (kg) should not use the drug because of an unfavorable risk-benefit profile.

February 13, 2014, Response Letter from the FDA.