FDA Warns Boehringer About Misleading Mirapex Ads

Law360, New York (October 15, 2008, 12:00 AM EDT) -- 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...
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