New Petadolex warning?

tdu Sun Aug 12, 2012 2:49 am

This was mentioned in another thread, but was sort of off topic to that thread. Has anyone else come across this recent Petadolex 'warning'? http://www.nyheadache.com/blog/?p=506 :

....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 and other brands), where it had to pass strict safety studies. However, Germany is no longer allowing butterbur to be sold there because the manufacturer changed its purification process and did not repeat all of the required safety studies. Butterbur made in Germany and in the US is still 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. This is why we no longer recommend butterbur for our patients.

This is only mentioned on the site linked, and on one other site that basically just used the article linked as a source and reposted it. I can't find any other information online relating to Petadolex changing anything with it's manufacturing, or anything related to Germany no longer allowing it to be sold there. There are of course the same warnings that have always come with any improperly processed Butterbur, but nothing relating to Petadolex specifically or the stuff mentioned about Germany. As far as I know, it was still being recommended as a treatment on some pretty major neurological websites just a couple of months ago when I saw some news updates about B2.

So does anyone know anything about this? Or anything about the site that posted the article? I emailed the manufacturer of the actual Petadolex brand and sent them a link the the article to ask them about it.

tdu Mon Aug 13, 2012 5:38 pm

Hey guys. I emailed the manufacturer of Petadolex that has the actual Petadolex name trademarked and sent them that link. I got this reply:

The article should be concerning since it's miss leading, and inaccurate.
The fact of the matter are as follows:

In 1978, we used methylene chloride as the extraction solvent for the
manufacturing of the active ingredient found in Petadolex. However, the
solvent was changed to a superior CO2 solvent in 1988 which did not change
the active ingredient or nature of the Petadolex ingredient. In addition,
the CO2method has a secondary benefit of selective depletion of toxic
pyrrolizidine alkaloids.

Unfortunately, the review process by the German health authority BfArM
regarding the original extract application of 1978 took decades, and as a
result the health agency declared the changes of extraction solvent
marketed after 1988 to be different than the application submitted in
1978, even though all analytical test methods employed demonstrated
identical results. There is no difference in the active ingredients of the
extract whether methylene chloride or CO2 is used as the solvent since.

What's important, all clinical studies published had been performed with
the unique and patented CO2 Petadolex extract manufactured by Weber &
Weber since 1988. Many different butterbur products are sold in the USA.
Those that are not labeled "Petadolex" use different ingredients and most
of them do not contain the labeled amount of petasins or no petasins at
all, some even contain toxic pyrrolizidine alkaloids. Products labeled
"Petadolex" contain the only extract that was used in published randomized
controlled clinical trials for migraine prevention and shown to be safe

Also, I found it interesting to note that the Dr who runs that blog sells his own migraine supplement as well. Does anyone know anything about that site or that Dr.?

New Petadolex warning?

New Petadolex warning?

Re: New Petadolex warning?