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

The Americas

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

Food and Drug Administration acts after online pharmacy raised concerns over NDMA contamination in December

The National

May 29, 2020

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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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Mercer, the investment consulting arm of US services company Marsh & McLennan, expects its wealth division to at least double its assets under management (AUM) in the Middle East as wealth in the region continues to grow despite economic headwinds, a company official said.

Mercer Wealth, which globally has $160 billion in AUM, plans to boost its AUM in the region to $2-$3bn in the next 2-3 years from the present $1bn, said Yasir AbuShaban, a Dubai-based principal with Mercer Wealth.

“Within the next two to three years, we are looking at reaching $2 to $3 billion as a conservative estimate and we do see an opportunity to do so,” said Mr AbuShaban.

Mercer does not directly make investments, but allocates clients’ money they have discretion to, to professional asset managers. They also provide advice to clients.

“We have buying power. We can negotiate on their (client’s) behalf with asset managers to provide them lower fees than they otherwise would have to get on their own,” he added.

Mercer Wealth’s clients include sovereign wealth funds, family offices, and insurance companies among others.

From its office in Dubai, Mercer also looks after Africa, India and Turkey, where they also see opportunity for growth.

Wealth creation in Middle East and Africa (MEA) grew 8.5 per cent to $8.1 trillion last year from $7.5tn in 2015, higher than last year’s global average of 6 per cent and the second-highest growth in a region after Asia-Pacific which grew 9.9 per cent, according to consultancy Boston Consulting Group (BCG). In the region, where wealth grew just 1.9 per cent in 2015 compared with 2014, a pickup in oil prices has helped in wealth generation.

BCG is forecasting MEA wealth will rise to $12tn by 2021, growing at an annual average of 8 per cent.

Drivers of wealth generation in the region will be split evenly between new wealth creation and growth of performance of existing assets, according to BCG.

Another general trend in the region is clients’ looking for a comprehensive approach to investing, according to Mr AbuShaban.

“Institutional investors or some of the families are seeing a slowdown in the available capital they have to invest and in that sense they are looking at optimizing the way they manage their portfolios and making sure they are not investing haphazardly and different parts of their investment are working together,” said Mr AbuShaban.

Some clients also have a higher appetite for risk, given the low interest-rate environment that does not provide enough yield for some institutional investors. These clients are keen to invest in illiquid assets, such as private equity and infrastructure.

“What we have seen is a desire for higher returns in what has been a low-return environment specifically in various fixed income or bonds,” he said.

“In this environment, we have seen a de facto increase in the risk that clients are taking in things like illiquid investments, private equity investments, infrastructure and private debt, those kind of investments were higher illiquidity results in incrementally higher returns.”

The Abu Dhabi Investment Authority, one of the largest sovereign wealth funds, said in its 2016 report that has gradually increased its exposure in direct private equity and private credit transactions, mainly in Asian markets and especially in China and India. The authority’s private equity department focused on structured equities owing to “their defensive characteristics.”

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