The US Food and Drug Administration asked five manufacturers to recall their extended-release formulations of the diabetes drug metformin on May 28, 2020. Corbis via Getty Images
The US Food and Drug Administration asked five manufacturers to recall their extended-release formulations of the diabetes drug metformin on May 28, 2020. Corbis via Getty Images
The US Food and Drug Administration asked five manufacturers to recall their extended-release formulations of the diabetes drug metformin on May 28, 2020. Corbis via Getty Images
The US Food and Drug Administration asked five manufacturers to recall their extended-release formulations of the diabetes drug metformin on May 28, 2020. Corbis via Getty Images

US advises recall of diabetes drug metformin over high levels of suspected carcinogen


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The US Food and Drug Administration has asked five pharmaceutical firms to voluntarily recall their formulations of the diabetes drug metformin after the agency found high levels of a possible cancer-causing impurity.

The FDA said the companies' extended-release versions of the drugs contained the probable carcinogen N-nitrosodimethylamine (NDMA) beyond acceptable limits.

NDMA contamination was responsible for the FDA's recall in April of the heartburn drug Zantac sold by Sanofi, as well as some other, generic versions of the treatment containing the ingredient ranitidine.

An FDA sokeswoman said it had not found elevated NDMA levels in immediate-release metformin.

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 had high levels of NDMA. It has not yet revealed the names of the four other firms.

However, patients should continue taking metformin tablets until their doctors can prescribe a replacement, the agency said.

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

Concerns over NDMA contamination of ranitidine and metformin formulations were raised by the online pharmacy Valisure.

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

Tests on 38 batches of metformin from 22 companies found that 16 batches from 11 companies had NDMA exceeding the FDA’s acceptable daily level of 96 nanograms, Valisure said. Several batches contained levels 10 times the daily acceptable intake limit.

A nanogram is one-billionth of gram.

NDMA is believed to be toxic to the liver and a possible factor in cancers of the stomach and bladder. It is found at low levels in processed foods such as cold meats and cheese and in alcoholic drinks and tobacco smoke.

Several brands of the blood pressure medication valsartan were recalled in 2018 and 2019 because of NDMA contamination.

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Five famous companies founded by teens

There are numerous success stories of teen businesses that were created in college dorm rooms and other modest circumstances. Below are some of the most recognisable names in the industry:

  1. Facebook: Mark Zuckerberg and his friends started Facebook when he was a 19-year-old Harvard undergraduate. 
  2. Dell: When Michael Dell was an undergraduate student at Texas University in 1984, he started upgrading computers for profit. He starting working full-time on his business when he was 19. Eventually, his company became the Dell Computer Corporation and then Dell Inc. 
  3. Subway: Fred DeLuca opened the first Subway restaurant when he was 17. In 1965, Mr DeLuca needed extra money for college, so he decided to open his own business. Peter Buck, a family friend, lent him $1,000 and together, they opened Pete’s Super Submarines. A few years later, the company was rebranded and called Subway. 
  4. Mashable: In 2005, Pete Cashmore created Mashable in Scotland when he was a teenager. The site was then a technology blog. Over the next few decades, Mr Cashmore has turned Mashable into a global media company.
  5. Oculus VR: Palmer Luckey founded Oculus VR in June 2012, when he was 19. In August that year, Oculus launched its Kickstarter campaign and raised more than $1 million in three days. Facebook bought Oculus for $2 billion two years later.
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