Tolerability of sumatriptan: clinical trials and post-marketing experience

Through December 1998, sumatriptan had been used to treat more than 236 mil lion migraine attacks world-wide. In clinical trials alone, more than 88 00 0 migraine patients had treated more than 300 000 migraine attacks with sum atriptan, and 2000 normal healthy volunteers had been exposed to the drug. This paper describes the safety and tolerability profile of sumatriptan in three sections: adverse events reported in clinical trials, special issues, and spontaneous post-marketing reports of adverse reactions. Data from the extensive clinical trials programme coupled with information from nearly 1 0 years of experience in clinical practice demonstrate that sumatriptan is generally well-tolerated, with an acceptable benefit-risk ratio when used p roperly. Significant cardiovascular and cerebrovascular events are rare but have been observed. This fact highlights the need for careful patient sele ction and vigilant adherence to the prescribing recommendations for sumatri ptan. The wealth of clinical trials and post-marketing information for suma triptan may be useful in guiding prescribing decisions for members of this class of drugs.