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, which I mentioned in a previous blog post, has 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”.
