U.S. FDA finds Nitrosamine Impurity in Certain Metformin Ext
The U.S. Food and Drug Administration (FDA) on May 28, 2020, has recommended five pharmaceutical firms to voluntarily recall their diabetes drug metformin after the agency found high levels of a possible cancer-causing impurity in some versions of the medication.

• The agency said the drugs contained the probable carcinogen N-nitrosodimethylamine (NDMA) beyond acceptable limits in their extended-release formulations alone.

• FDA testing has not shown NDMA in immediate-release (IR) metformin products (the most commonly prescribed type of metformin).

• However, the agency said patients should continue taking metformin tablets even after recalls occur until they consult with their health care professional who can prescribe a replacement.

• NDMA contamination was responsible for the recall of Angiotensin II receptor blockers (ARBs) (blood pressure and heart failure medicines) and ranitidine and nizatidine (heartburn medicines)

• The FDA, which said it would post the company recall notices on its website, named Canadian company Apotex Corp as one of the firms whose metformin tablets have high levels of NDMA. It has not yet revealed the names of the four other firms.

Source: https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin
S S and 7 others like this6 shares
Dr. S●●●●●m S●●●●y P●●●●●l
Dr. S●●●●●m S●●●●y P●●●●●l General Medicine
Now this is a matter of grave concern. Why a Vountary recall? If concrete proof is present,go ahead and issue orders for complete recall ! Certainly a new trend of sudden discoveries of high levels of Ndma are now being found in so many essential drugs ! It is also a matter of concern that if they are being discovered now, one can only wonder which other drugs have these chemicals but the respected FDA has been unable to test till date due to lack of resources.... Read more
May 29, 2020Like1
Dr. J●i B●●●●i
Dr. J●i B●●●●i Obstetrics and Gynaecology
Unless there is an alternative to these essential drugs it' s really difficult to avoid it.
May 31, 2020Like