FDA CITATION PROMPTS ELI LILLY TO WITHDRAW BROCHURE
The FDA has sent a notice of violation letter to Eli Lilly over a patient brochure for the company's cancer medication, Alimta, prompting the drugmaker to withdraw the brochure from circulation.
According to the letter, the brochure is "misleading because it omits material facts and risk information essential to the safe and effective use of Alimta. The patient brochure thus misbrands the drug in violation of the Federal Food, Drug and Cosmetic Act."
The letter goes on to state that the patient brochure fails to present either of the two approved indications for the drug, which is used to treat mesothelioma and non-small-cell lung cancer, and "provides information and references for a number of other types of cancers for which Alimta is not indicated, potentially creating the misleading impression that Alimta is approved to treat a wide range of cancers." The letter also cites the company for failing to reveal that Alimta "may cause fetal harm when administered to a pregnant woman."
Upon receiving the letter, Eli Lilly "took immediate steps to retrieve and destroy all copies of the patient educational brochure," spokesman Gregory Clarke said. "The brochure itself has the full prescribing label for Alimta in the back pocket, as well as a website and [toll-free] number information, but the FDA felt the indication should be stated clearly on the first page." Clarke said future editions of the brochure will contain the indication information on the first page as required.
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