Boehringer Ingelheim Gets Warning Letter for Aggrenox Promotion

March 30, 2005

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has cited Boehringer Ingelheim Pharmaceuticals for running a journal advertisement containing unsubstantiated superiority claims about its stroke drug Aggrenox.

The journal ad, which was submitted to the FDA in September 2004, contained language suggesting that Aggrenox (aspirin/extended-release dipyridamole) may be more effective than Plavix (clopidogrel), a competing stroke medication marketed jointly by sanofi-aventis and Bristol-Myers Squibb.

That claim of superiority, which Boehringer Ingelheim based on "indirect comparisons," isn't supported by clinical research, DDMAC says in an untitled letter.

"Drug comparisons that represent or suggest that a drug is safer or more effective than another drug are misleading if the representation or suggestion has not been demonstrated by substantial evidence obtained from adequate and well-controlled head-to-head clinical trial," DDMAC states in the letter.

In addition to the misleading superiority claims, Boehringer Ingelheim failed to include adequate risk information in the Aggrenox promotion, DDMAC said. The promotion also failed to include a precaution concerning the risks of intracranial hemorrhage, the letter says. DDMAC ordered Boehringer Ingelheim to immediately stop disseminating the ad, and to submit a written response to the untitled letter by April 5. A Boehringer Ingelheim spokesman said the company plans to pull the journal ad and is working with the FDA to make the necessary revisions. To view the Boehringer Ingelheim warning letter, go to http://www.fda.gov/cder/warn/2005/12917.pdf (http://www.fda.gov/cder/warn/2005/12917.pdf).