Posted on 10/11/2020 8:53:36 AM PDT by E. Pluribus Unum
NEW YORK (CBSNewYork/CNN) — A widely-used diabetes drug is being recalled after manufacturers found it contained unacceptably high levels of a cancer-causing contaminant.
Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride extended-release tablets because their levels of NDMA, a “probable human carcinogen,” were higher than the acceptable daily intake limit of 96 nanograms per day, according to a recall published this week by the US Food and Drug Administration (FDA).
Metformin tablets are used to treat type 2 diabetes and are designed to lower glucose levels.
The recall applies to metformin tablets between 500 mg and 750 mg, sold under the brand name Time-Cap Labs, Inc.
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The recall expands an earlier recall of the same product from this summer. But it’s just one of several metformin products that have been found to contain NDMA in the last year. Seven other pharmaceutical companies have issued recalls for metformin hydrochloride extended-release tablets due to their carcinogenic contents.
The FDA is still investigating where NDMA comes from and how it ends up in metformin products. Most levels found in medications are generally low and fall within the FDA’s accepted daily intake, but recently recalled medications exceed that. Marksans Pharma Limited, India, however, did not reveal how much NDMA its recalled products contained.
(Excerpt) Read more at newyork.cbslocal.com ...
Sadly, this is not a rare occurrence with pharmaceuticals made in India.
There are a few other drugs that have had NMDA in them. I’m not sure this is something specific to Indian drug makers.
That’s the problem with generic drugs made in India or China - the quality control isn’t there and who knows what contaminants are in them. And yet our healthcare system relies on cheap drugs made overseas to keep costs down.
Ping
My current manufacturer isn't on the recall list...yet.
I hope this is something President Trump concentrates on in his second term...don't bring just the PPE manufacturing back to the US, but ALL medical manufacturing back to the US.
“I’m not sure this is something specific to Indian drug makers.”
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I don’t know but last year there was a widespread shortage of the angiotensin receptor blocker (ARB) drugs used for high blood pressure. The shortage was caused by contamination problems in the Indian manufacturing locations to which much production was moved by the pharmaceutical industry. That affected me and my doctor had to move me to a different drug. The common factor to these contamination problems was Indian (and some Chinese) manufacturing facilities.
I personally consider Metformin to be poison. I have zero tolerance to that drug. It causes VIOLENT and EXPLOSIVE runs.
Indian quality control. About as bad as Communist Chinese quality control. Errr no quality control.
It is not necessarily contamination that adds NDMA to those drugs, but side reactions in the synthesization process, or by break down by heat in storage. These levels of NDMA may have always been around in some drugs in the past, but were not detectable by the the testing equipment in use at that time.
Heck, even bacon has some NDMA in it.
A common side effect that gradually lessens, can be abated with Gas-x and Immodium. The best daily abatement is half a banana.
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Much less of a problem with the ER Extended Release version.
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This “poison” has saved my life, letting me self heal with better diet and exercise. I am no longer diabetic. In 6 more months of progress I can start reducing all my diabetic meds.
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We have to get our blood sugar down to keep from wrecking our kidneys.
It was the Extended Release, symptoms were for over 3 months and since I had (at the time) to be in front of an audience giving presentations, simply did not work for me. I am now on Jardiance and Tradjenta with no side effects. More expensive but at least it works.
I personally consider Metformin to be poison. I have zero tolerance to that drug. It causes VIOLENT and EXPLOSIVE runs.
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Ditto for my wife and me. It did not abate and we both had to start taking insulin injections. Our docs finally prescribed Victoza and insulin. Cash price for the Victoza in our area is $1,200 per month. Fortunately, for us we have great ins. and no deductible, we each paid, I still do, $15 per month co pay.
Look up Dr. Jason Fund and get off the insulin. It will destroy your cells
I started Glipizide with the ongoing Metformin about 9 months ago. Great results, but nausea is a side effect in the mornings. For the first time in years, I am hungry in the morning, great numbers, A1C is 6.0 (started at 13, 3 years ago).
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The best treatment is activity/exercise. Huffing and puffing. The more I work out the better the numbers. If I could do enough running I could end all meds. Still need to eat sensibly, keto as much as possible.
OR CHINA. This is about the 12th recall in 2 yrs. TIME TO EMBARGO THEM.
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