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Carcinogen in Metformin/Glucophage

metformin contaminantion generic drugs carcinogens

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#1 Michael

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Posted 02 June 2020 - 05:20 PM


All:

Some of you will be taking the common and very good diabetes drug metformin (brand names Glucophage and (less frequently) Fortamet or Glumetza), and many of you may well have friends or family that do. This includes not only diabetics and prediabetics, but subtantial numbers of otherwise-healthy life extensioÏnists, who have been mislead into believing that it is a potential anti-aging drug on the basis of lazy and/or ignorant interpretation of a number of flawed metformin studies (see also here and here).
FDA has asked 5 companies to voluntarily recall their extended-release product for containing a carcinogenic contaminant at levels exceeding the legal limit.

The five manufacturers are Amneal Pharmaceuticals, Actavis Pharma, Apotex Corp, Lupin Pharma, and Marksans Pharma Limited (DBA Time Cap Laboratories).

Here is the FDA public announcement.

They did not name the five companies in that press release, but they WERE named in a letter to the generic testing and test-approved generic pharmacy Valisure, who first alerted FDA both to this contaminant in metformin, and previously to the same contaminant in two other classes of drug leading to an even larger wave of recalls.

Health Canada announced that they were investigating in late last year; in February, they announced a recall of Apotex *regular* metformin, and in March, Ranbaxy regular metformin and Jamp metformin.

In a
PREVIOUS press release, FDA disclosed testing on several products found NOT to be contaminated, or contaminated at low levels, "similar to the levels you would expect to be exposed to if you ate foods like grilled or smoked meats."

(Frankly, I would avoid the two Actavis products if I could find an alternative that wasn't actively under recall request).

Additionally, FDA has also detected the same contaminant in metformin in other countries, at levels substantial enough to elicit a public notice but below the legal limit in the US. Unfortunately, they have not disclosed the manufacturers of these products.

Everyone should check their product and seek a replacement from pharmacies if they are using one of these brands; they should NOT simply go off of their drug (unless they're taking it under the delusion that it's an anti-aging agent, in which case they should just quit).

(I would also encourage anyone using generic drugs with a valid prescription to consider using Valisure for their supply. I have no financial or other interest in this company: I am highlighting them as good corporate citizens and a safe, validated supply of pre-tested generic drugs).

Background:
You may recall an incident last winter involving a class of hypertension drugs ending in -sartan, as well as ranitidine/Zantac (sold as Ranitidina in MX), a proton-pump inhibitor sold mostly for heartburn due to acid reflux, but also sold as an antihistamine.

At the time, all of these drugs were contaminated with N-nitrosodimethylamine (NDMA) (or in the case of some of the sartans, the chemically-related N-methylnitrosobutyric acid (NMBA)), which are probable human carcinogens. It got into the ARBs as an impurity, because of a relatively recent change in the use of a solvent in the synthesis; the solvent, when not totally removed, can degrade into NMDA. As a result, valsartan has also been found to be contaminated DMF, the solvent in question, which is ALSO a probable human carcinogen!

Now the same carcinogen has been identified at dangerous levels in metformin.


Edited by Michael, 02 June 2020 - 06:47 PM.
fixing malformed URLs

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#2 YOLF

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Posted 02 June 2020 - 06:30 PM

What's the likelyhood of the contract manufacturer also making foreign versions of the drug which are also contaminated? Brands such as USV Limited Metformin which is available from various Indian Telemeds.



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