FDA slaps Eli Lilly for ’false or misleading claims’ in ads for Cymbalta

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INDIANAPOLIS, Indiana — The U.S. Food and Drug Administration has slapped drugmaker Eli Lilly & Co. on the wrist for making “false or misleading claims” in advertisements for Cymbalta, a drug for pain and anxiety relief.

Specifically, the FDA cited Lilly for omitting and minimizing risk information about the drug, and overstating the drug’s efficacy, according to a copy of an undated letter the FDA sent to the drugmaker.

The FDA instructed Lilly to stop disseminating the ads in question and send it a letter by Jan. 22 saying whether the company intends to follow the FDA’s orders. A Lilly spokesman didn’t immediately return a call.

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In one print ad that featured a woman curled up on a couch seemingly holding her knee in pain, Lilly failed to communicate risk information in the main part of the ad, the FDA said. Potential adverse reactions to the drug include nausea, headache, dry mouth, insomnia, constipation, fatigue, diarrhea, decreased appetite, dizziness and somnolence.

Another ad, which appeared in the WebMD Little Blue Book of Rheumatology, “misleadingly minimizes the serious risks” associated with the drug. The same ad overstates the efficacy of the drug in treating fibromyalgia, a condition marked by chronic pain of the muscles, tendons and joints, by implying that over half of fibromyalgia patients treated with Cymbalta will achieve a 30 percent improvement in pain. No data exists to support that claim, the FDA said.

In addition to the enforcement letter on Cymbalta, the FDA sent out similar letters to three other drugmakers: Cephalon for its lymphoma treatment Treanda; Bayer for birth-control implant Mirena; and Amylin Pharmaceuticals for diabetes drug Byetta, the Boston Globe reported. Lilly partners with Amylin on Byetta.

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Brandon Glenn

Brandon Glenn

Brandon Glenn is the Ohio bureau chief for MedCity News.

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I don’t know about anyone else, but Cymbalta did wonders for my Fibromyalgia.
Yes, the side effects are awful, but well worth tolerating to be able to move and walk again. Heck, we get many of those side-effects as regular symptoms of FMS anyway lol

My only complaint, is the cost. Even at a discount, I was paying $150 a month for it, with no insurance.
I can’t wait for a Generic version to come out in a couple years!

Comment by Lisa B — January 15, 2010 @ 3:45 pm

Zyprexa was pushed by Lilly Drug Reps.
They called it the “Five at Five” (5 mg at 5 pm to keep nursing home patients subdued and sleepy) and “VIVA ZYPREXA” (Zyprexa for everybody) campaigns to off label market Eli Lilly Zyprexa as a fix for unapproved usage.

I am a living example of Zyprexa gone/done wrong was given it 1996-2000 off-label for PTSD got sudden high blood sugar A1C 14.7 in January 2000.The stuff was worthless for my condition PTSD and cost me thousands in co-pays gave me diabetes.

Daniel Haszard

Comment by Danny Haszard — January 16, 2010 @ 2:59 am

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