Lilly warned over Alimta patient booklet

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The FDA slapped Eli Lilly with a warning letter over a patient brochure for its oncology treatment Alimta, saying the mailer glossed over the drug's indications and failed to mention its risks.

The Division of Drug Marketing, Advertising and Communications (DDMAC) letter has called the brochure misleading “because it fails to present either approved indication for Alimta.” Namely, for non-small cell lung cancer and, when used in combination with cisplatin, for mesothelioma.

In addition, DDMAC noted, the brochure provided information on types of cancers for which the drug is not indicated, “potentially creating the impression that Alimta is approved to treat a wide range of cancers”—a point the agency called “particularly concerning” because there exist approved treatments for some of the cancers covered.

DDMAC also took issue with the brochure's omission of risk information for pregnant patients, and requested that the company immediately pull the booklet.

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