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FDA: Alimta brochure is misleading

Patient pamphlet for cancer drug Alimta omits key facts and risk info, regulators say

Associated Press, August 1, 2006

Federal regulators warned pharmaceutical maker Eli Lilly and Co. on Monday about a "misleading" marketing brochure for its cancer drug Alimta.

The Food and Drug Administration said the Indianapolis-based company published a 34-page patient brochure that "omits material facts and risk information essential to the safe and effective use" of the two-year-old drug.

Alimta is used to treat mesothelioma and non-small-cell lung cancer. It also can cause fetal harm if women take the medication while pregnant.

Last year the drug accounted for $463 million in sales, making it the company's ninth-best-selling drug.
Company spokesman Greg Clarke said Lilly had not received the FDA's warning letter, which was posted on the agency's Web site Monday.

"We will naturally work with the agency to make sure the information that's relevant and important for patients is out there, but we've not actually formally received the letter," Clarke said.

Specifically, the FDA said Lilly failed to explain what cancers the medication was approved to treat.
The brochure, which has a 2004 copyright, also failed to provide a warning about administering the drug during pregnancy.

Lilly has until Aug. 11 to respond to the FDA's drug marketing division about how the company will discontinue the brochure.

The Associated Press left a message for an FDA spokeswoman.

Lilly shares fell 14 cents to $56.77 in trading Monday on the New York Stock Exchange.