An update on butterbur (Petadolex) – we still don’t recommend it
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”.
I still recommend Petadolex brand of butterbur only after trying several other preventive migraine therapies. One concern is that patients will substitute the fairly expensive Petadolex with a cheaper and potentially dangerous brand of butterbur. Regarding the most recent paper, the number of patients in the reported trials is relatively small and if it was a drug the FDA would require a much larger study to assess its safety
Have your recommendations changed at all given the recent paper published by Cephalalgia?
Safety profile of a special butterbur extract from Petasites hybridus in migraine prevention with emphasis on the liver
HC Diener, FG Freitag, U Danesch First Published May 2, 2018
There have been no new developments in treating migraines with butterbur. Petadolex is still the best brand to try if other options have failed. I would still recommend taking Petadolex for 3 months and then taking one month break and doing a blood test to check your liver functions. Butterbur should not be taken by pregnant women in any form or brand.
Hi, do you have any updates on butterbur (Petadolex)? Is there any brand of butterbur you can recommend now assuming it is accessible and price is not an issue?
I also take magnesium, coq10, riboflavin. I am not a candidate for other “usual” preventatives due to low blood pressure. I contacted biogenesis and they do not use Petadolex brand in their product produced by Weber and Weber, but stated the butterbur is “PA free” and “Made in Germany under strict standards”. I would like to try Petadolex at the 150 mg level, but am confused by all the different manufacturers (distributors?) calling their product Petadolex. Are companies stating Petadolex in the name using Weber & Weber product? Any idea if the brand Integrative Therapeutic Petadolex or brand Enzymatic Therapies Petadolex are manufactured directly by Weber & Weber?
I checked the label of this product and it appears that it contains only 50 mg of butterbur into tablets which is the recommended daily dose. Our clinical trials which we have conducted indicate that you need at least 150 mg of butterbur to obtain a significant benefit. Also, the company does not provide any information as to the origin of butterbur. The product that is most likely to be safe and effective as manufactured by a German company Weber & Weber. It is available under several different names, including Petadolex. Besides nortriptyline and Topamax there are several other effective prophylactic migraine medications, as well as several natural supplements, such as feverfew, Boswellia, ginger, and other. As far as abortive medications besides Relpax and DHE the are several other triptans which can be effective. There is a great deal of controversy about the maximum safe amount of triptans that can be taken – check out this blog post, which has generated the largest number of comments. You may also want to read this recent post about the eyedrops for acute migraines.
Dr Mauskop,
Is there a safe version/product of butterbur that you do recommend? I have purchased Migraclear-Ultra by Biogenesis. Do you know anything about the safety of the Butterbur in this particular product? I suffer from chronic , frequent (3 times per week) severe migraines. I cannot tolerate topamax or nortriptyline. I am allergic to sulfur (cannot use Zonisamide) and and have low blood pressure. I utilize Botox but it is not enough. I utilize DHE 45 injections weekly and or Relpax as abortative but cannot take as often as needed. I am in Washington where there is a shortage of headache docs.