Regulator Asks 5 Firms To Recall Diabetes Drug Over Carcinogen Concerns.

Regulator Asks 5 Firms To Recall Diabetes Drug Over Carcinogen Concerns

The agency said the drugs contained probable carcinogen N-nitrosodimethylamine beyond acceptable limits.

The US Food and Drug Administration (FDA) said on Thursday it 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.

NDMA contamination was responsible for the recall of heartburn drug Zantac sold by Sanofi SA and some generic versions of the treatment last year.

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.

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.

In December, the FDA had started an investigation into metformin, which is used as an initial treatment for patients with type 2 diabetes.

Online pharmacy Valisure said in March that its independent tests showed high levels of NDMA in metformin made by 11 companies, including Amneal Pharmaceuticals Inc and Aurobindo Pharma Ltd.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

Comments

Related news

Millions Of Australians Back In Lockdown Amid Melbourne Virus Outbreak.

Australia's second largest city, Melbourne, went back into lockdown at midnight on Wednesday, forcing five million Australians to stay home for all but essential business for the next six weeks to...

WHO Advance Team Heads To China To Set Up Probe Into Coronavirus Origin.

A two-member advance team of World Health Organization (WHO) experts has left for China to organise an investigation into the origins of the novel coronavirus behind a pandemic that has killed more...

Trump issues order commuting Roger Stone’s sentence in Russia probe.

The move, though short of a full pardon, is sure to alarm critics who have long railed against the president's repeated interventions in the nation's justice system.

Amazon Bans, Then Un-Bans TikTok From Employee Mobile Devices.

In the span of a few hours on Friday, Amazon.com Inc banned and then unbanned the TikTok video sharing app from employee mobile devices, calling the move a mistake.

Coronavirus and use of wet wipes blocking sewers, leading to challenges at treatment plants.

In London, flushed material can cause damage to equipment, takes up labour and can lead to blockages throughout the entire sewer system.

By continuing to browse World News (UAZMI), you acknowledge that you have read the Terms of Use and agree to the use of cookies