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Contamination of pharmaceuticals with potential carcinogens

Posted: Thu Jan 16, 2020 10:02 am
by GeenDienst
https://www.medscape.com/viewarticle/92 ... 8620&faf=1
The FDA has begun testing samples of the diabetes drug metformin for the carcinogen N-Nitrosodimethylamine (NDMA), the agency announced Wednesday. Contamination with this same substance led to recalls of blood pressure and heartburn medications within the last 2 years.
...
The FDA's announcement comes on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency's request that manufacturers test for NDMA, according to Bloomberg News.
...
Valisure, an American online pharmacy that tests every batch of drugs it sells before dispensing them, has rejected 60% of its metformin since it started testing for NDMA in March.
Plus the usual "don't stop taking it" messages, obviously.

This is perhaps a small downside of generic availability, you never quite know where the stuff's coming from, however it's boxed. And whatever protection the EMA can provide probably becomes moot in UKadia soon.

NB: The Singapore authority recalled 3 out of 46 versions of metformin, 2 of them from the same manufacturer. So not a huge problem there, but we really shouldn't be seeing this.

Fun metformin fact, there's so much of this going in and out of people it's detectable in drinking water.

Re: Contamination of pharmaceuticals with potential carcinogens

Posted: Mon Jan 20, 2020 8:40 am
by bmforre
GeenDienst wrote:
Thu Jan 16, 2020 10:02 am
https://www.medscape.com/viewarticle/92 ... 8620&faf=1
The FDA has begun testing samples of the diabetes drug metformin for the carcinogen N-Nitrosodimethylamine (NDMA), the agency announced Wednesday. Contamination with this same substance led to recalls of blood pressure and heartburn medications within the last 2 years.
...
The FDA's announcement comes on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency's request that manufacturers test for NDMA, according to Bloomberg News.
...
Valisure, an American online pharmacy that tests every batch of drugs it sells before dispensing them, has rejected 60% of its metformin since it started testing for NDMA in March.
Plus the usual "don't stop taking it" messages, obviously.

This is perhaps a small downside of generic availability, you never quite know where the stuff's coming from, however it's boxed. And whatever protection the EMA can provide probably becomes moot in UKadia soon.

NB: The Singapore authority recalled 3 out of 46 versions of metformin, 2 of them from the same manufacturer. So not a huge problem there, but we really shouldn't be seeing this.

Fun metformin fact, there's so much of this going in and out of people it's detectable in drinking water.
And that was published in 2014, 6 years ago.

How do these detected levels compare to the therapeutic levels metformin is commonly used at?

Re: Contamination of pharmaceuticals with potential carcinogens

Posted: Mon Jan 20, 2020 11:51 am
by GeenDienst
Considering people take about 1.5 g or 2 g per day, vanishingly low. I told you it was only a fun fact.