Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, March 22 (DDMAC).After reviewing a journal advertisement for the company's stroke drug, Aggrenox (aspirin/extended-release dipyridamole dipyridamole /di·py·rid·a·mole/ (di?pi-rid´ah-mol) a platelet inhibitor and coronary vasodilator used to prevent thromboembolism associated with mechanical heart valves, to treat transient ischemic attacks, and as an adjunct in ), DDMAC DDMAC Division of Drug Marketing, Advertising and Communications cited Boehringer Ingelheim for unsubstantiated superiority claims.
According to the FDA-approved labeling, Aggrenox is a combination antiplatelet agent indicated "to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis."
But the ad, which was submitted to FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. in September, contained suggestions that Aggrenox may be more effective than Plavix (clopidogrel), a stroke medication jointly manufactured by Bristol-Myers Squibb and Sanofi-Aventis. The agency contended, however, that Boehringer Ingelheim based the claims of superiority on "indirect comparisons" that were not supported by clinical research.
Additionally, DDMAC stated that Boehringer Ingelheim failed to include adequate risk information in the Aggrenox promotion; in particular, the company failed to include a precaution concerning the risk of intracranial hemorrhage.
The main part of the ad also failed to include warnings concerning alcohol consumption, coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or abnormalities, peptic ulcer disease Peptic ulcer disease (PUD)
A stomach disorder marked by corrosion of the stomach lining due to the acid in the digestive juices.
Mentioned in: Indigestion
peptic ulcer disease See Duodenal ulcer, Gastric ulcer, GERD. and pregnancy. F-B; Doc. 13419W