FDA Warns Boehringer About Misleading Mirapex Ads
By Samuel Howard · 2008-10-15 00:00:00 -0400
German pharmaceutical company Boehringer Ingelheim GmbH misled consumers and doctors about the safety and efficacy of Mirapex, the restless-leg syndrome treatment, according to the U.S. Food and Drug Administration.
The watchdog revealed Tuesday that regulators sent Boehringer a warning letter in September upbraiding the company for disseminating promotional materials that failed to mention the risks associated with Mirapex and overstated its uses.
The pharmaceutical company sent out two consumer-directed printouts for Mirapex that violated the FDA's labeling laws by omitting the required warnings about the hazards associated with using the drug, the agency said.
"These materials raise significant public health and safety concerns by suggesting that Mirapex is safer than has been demonstrated," the letter said.
One Boehringer printout misled consumers by publicizing the drug but withholding any mention of the risks associated with using Mirapex, which include drowsiness and falling asleep, hypotension, hallucinations and other adverse reactions, the letter said.
A second ad discloses common side effects associated with Mirapex, such as nausea, headache and fatigue, but minimizes their seriousness or duration and altogether fails to cite the serious risks of taking the drug, the FDA said.
Boehringer also distributed a Mirapex advertisement to medical professionals that promoted prescribing the drug beyond the FDA approved uses, the agency said. This third ad touts the use of Mirapex for treating restless-leg syndrome, failing to note that the drug is only approved for prescription to patients with moderate-to-severe cases of RLS.
Additionally, the ad misleadingly implies that Mirapex is useful to a broader range of patients than demonstrated and claims that 10 percent of the adult population suffers from the syndrome, the agency said.
Representatives for Boehringer were not available for comment Wednesday.
The Division of Drug Marketing, Advertising and Communications requested that Boehringer immediately cease using the "violative promotional materials" for Mirapex and send a letter saying whether the company would comply.
The FDA also requested that Boehringer indicate how it would remove the ads from circulation and disseminate "truthful, non-misleading and complete corrective messages" to consumers and professionals who received the promotional materials, according to the letter.
No response has been posted to the FDA Web site, but the deadline for Boehringer's reply to the regulators was Tuesday.
Mirapex is the focus of hundreds of product liability suits nationwide alleging that the drug, which is also used to treat symptoms of Parkinson's Disease, triggers compulsive behavior in patients, which Boehringer - and Pfizer Inc., which markets the drug - never disclosed.
In August, a federal judge dealt a blow to Boehringer and Pfizer, awarding $8 million to a plaintiff who claimed the drug caused his compulsive gambling problem; the multidistrict litigation is being conducted in the U.S. District Court for the District of Minnesota.
Not sure if this is new, in my news feed, or 15 yrs old...
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