Amgen brochure misleading, FDA warns
Pharma Compliance Alert, November 5, 2008
Amgen’s direct-to-consumer patient brochure for Senispar tablets improperly omits and minimizes risks associated with the drug and broadens its uses, according to an FDA warning letter.
The brochure completely omits one serious side effect of Senispar and fails to disclose any of the serious risks associated with the drug. In addition, Amgen minimizes the need for continual blood testing for patients taking Senispar.
The brochure also improperly emphasizes the benefits by using an easy to read layout over several pages but presents warnings and risks in a single paragraph on the back cover of the brochure. Pharmaceutical companies are required to provide a balanced presentation of risk and benefit information.
Amgen also broadened the use of Senispar by failing to communicate the drug’s full approved indication, including material limitations, according to the FDA.
The agency requested Amgen stop distributing the brochure and provide the FDA with a list of all promotional materials similar to the Senispar brochure and explain how it plans to discontinue use of such materials.
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