Objective To report on the safety of a patented special butterbur root extract used for migraine prevention.
Background Two placebo-controlled clinical trials have been conducted supporting the beneficial use in humans.
Methods Results from acute, subchronic and chronic animal toxicity studies as well as from mutagenicity studies are reported. Safety data gained from clinical trials, postmarketing surveillance studies and pharmacovigilance are evaluated and discussed.
Conclusion The patented special butterbur root extract is safe for the treatment in humans.