Are you taking Metformin? Be Alert for contamination with NDMA - A toxic substance which could cause Cancer- USFDA

[namaha]

If you are a Diabetic, in all possibilities you may be taking Metformin. Please read the strip and see whether it is "extended release" or "Sustained release".

Then it may be possible that it may contain a toxic substance called nitrosodimethylamine (NDMA), a potential carcinogen generated / contaminted during the manufacturing process..How it happens and how to prevent it is still under investigation as per US FDA.

It was found out by US FDA and several pharma manufacturers from all over the world are involved , as the manufacturing process remains the same all over.

Even if Metformin is in a combination form with any other drug, read the label. If it is written as Sustained release or extended release.. you may please talk to your Doctor and try to get seperate ones. It is better to take precautions until the investigation is clear..

Apart from some USA based pharma companies, few Indian companies who supply the drug to USA have also been advised to " Recall" of the medication from the USA market.

In USA, USFDA ordered many pharma manufacturers to recall the medications from the market. Unfortunately, in many countries the recall process is not strong.

Apart from long term side effects of possible carcinogenic effects, it may affect your liver.. in short term you may have stomach cramps, heavy stomach, stomach may remain full all the time.

In case you come across such side effects, please talk to your doctor and switch over to the plain / standard Metformin which seems to have no contamination...

FAQ are given in the 2nd link from US FDA .

Stay Safe , Stay Healthy !

fda.gov/drugs/drug-safety-a...

fda.gov/drugs/drug-safety-a...

[sandybrown]

Thank you for this information.

[rvsiv]

Thank You..

[sandybrown]

Below information is from an email I received:

"TOPIC: Metformin Hydrochloride for Extended-Release Oral Suspension by Sun Pharmaceutical Industries: Recall - Due to N-Nitrosodimethylamine Content Above the Acceptable Daily Intake Limit

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Sun Pharmaceutical Industries is recalling one lot (AB06381) of RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake limit established by the FDA.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

To date, Sun Pharmaceutical Industries has not received any reports of adverse events related to this recall.

BACKGROUND: RIOMET ER (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

RECOMMENDATION: Patients taking RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:"

[namaha Administrator]

Sun Pharma is not the only pharma company..

There are at least a dozen companies across the world who have been instructed for recalling their Metformin ER or SR drugs....for contamination of NDMA.... Which was found out by USFDA by testing sample in the lab....

This is going on since last 3-4 months

Pharma companies may always defend their product ..☹️