Suprax promotions cited in FDA ad letter
FDA letter cites Wyeth Suprax promotional mailers as lacking adequate risk information. With the exception of the disclosure that "GI upset is the most frequently reported side effect," the materials otherwise "fail to present any risk information for Suprax, including the bolded warning from the PI concerning serious acute hypersensitivity reactions that may occur in up to 10% of patients with a history of penicillin allergy," letter states...
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