Safety of a patented special butterbur root extract for migraine prevention.
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.


CONCLUSIONS
The patented special butterbur root extract is safe for the treatment in humans.
Danesch
Ulrich
U
Weber and Weber, Inning, Germany.
Rittinghausen
Reiner
R
D000293:Adolescent; D000818:Animals; D002648:Child; D005060:Europe; D006801:Humans; D008881:Migraine Disorders / Q000517:prevention & control*; D010330:Patents as Topic; D036901:Petasites; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use* / Q000633:toxicity; D028321:Plant Preparations / Q000009:adverse effects / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D051381:Rats; D017208:Rats, Wistar; D012307:Risk Factors
D010936:Plant Extracts; D028321:Plant Preparations