Boehringer Ingelheim Gets Warning For Mirapex Ads

摘要

Boehringer Ingelheim disseminated consumer and professional advertising for its Mirapex treatment for restless leg syndrome (RLS) that failed to include risk information and effectively broadened the drug's indications, according to an FDA warning letter. The Sept. 29 letter, by the FDA's Division of Drug Marketing, Advertising and Communications, says two consumer pharmacy printouts did not disclose risk information. The first printout did not include any risk information but listed the Miraprex (pramipexole di-hydrochloride) indication, the FDA says in the letter. The second document did not include warnings about risks associated with use of the drug, and the FDA says it appears to have been distributed with a package insert, in violation of 21 CFR 201.100(d).