Federal Register Notice: FDA is seeking public comment on the proposed collection of information on FDA's burden estimates to distribute an Internet-based questionnaire to measure the compliance of prescribers with the contraindication of the use of triptans in migraine headache patients with vascular disease. Over the past decade, a category of drugs referred to as triptans, has been shown to be efficacious in treating migraine and has been prescribed to millions. However, triptans are routinely contraindicated in patients with vascular diseases due to associated rare occurrence of myocardial infarction, stroke, and other ischemic events. In view of the wide use of this class of drugs and the potential impact on public health, FDA believes it would be of great use to better understand the prescribing practices as a result of this contraindication.

FDA plans to use the Internet to recruit triptan-user migraine headache patients to determine whether prescribers follow the labeling recommendation to avoid prescribing this class of drugs to patients with pre-existing cardiovascular, cerebrovascular, or peripheral vascular syndromes or with cardiac risk factors. The study is intended to measure the proportion of patients that were prescribed triptans although they have pre-existing cardiovascular, cerebrovascular, or peripheral vascular syndromes. Comments should be submitted by 1/16/04. To view this notice, click here.