The New York Headache Center participated in a large (245 patients) placebo-controlled trial of butterbur, which showed that 150 mg of butterbur is effective in the prevention of migraine headaches when compared to placebo. The results were published in Neurology and the American Academy of Neurology endorsed the use of butterbur for the prevention of migraine headaches. Because butterbur is highly toxic to the liver and can cause cancer we were very happy to have a highly purified product manufactured in Germany (sold as Petadolex), where it had to pass strict safety studies. However, Germany does not allow butterbur to be sold there because the manufacturer changed its purification process and did not repeat all of the required safety studies. Butterbur is still made in Germany and is sold in the US, but our FDA does not regulate herbal products and does not require the extensive safety tests that are required in Germany.
The manufacturer of Petadolex brand of butterbur sent me an email saying that the FDA conducted an inspection of their manufacturing plant in Germany. However, my concerns about butterbur have not been addressed. Here is my email response to the manufacturer:
“Thank you for this additional information. It is good to see that the FDA conducted a “comprehensive inspection” of the manufacturing facility in Germany. However, my concerns about the safety of Petadolex are not due to possible deficiencies in manufacturing, but are related to the extraction process. As far as I know, this is why German and UK governments still do not allow the sale of Petadolex and this is why I do not recommend Petadolex to my patients. I am also concerned that because Petadolex is fairly expensive, many patients will decide to buy a cheaper brand of butterbur, which can be truly dangerous. Once Petadolex is cleared for sale in Germany I will be happy to resume recommending it to my migraine patients”.
Some of the above text is from my previous posts a few years ago, but I still do not routinely recommend butterbur. If a patient expresses an interest in it and if other herbal treatments and supplements fail, I will provide directions for its use and will emphasise the importance of not substituting Petadolex for a cheaper brand.
