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.
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.