Singapore recalls three versions of diabetes drug metformin

06-Dec-2019 Intellasia | Bloomberg | 6:02 AM Print This Post

Singapore health officials have recalled three of 46 versions of the diabetes drug metformin after finding amounts of a cancer-causing substance that was “above the acceptable level”.

The recalled drugs had been sold locally for only a short time, and the risk to patients who had taken them is low, Singapore’s Health Sciences Authority said in a statement.

Its action comes as global health regulators are looking into whether the widely used drugs may contain unsafe levels of the carcinogen NDMA that has previously been found in heart and gastric medications

Metformin is widely prescribed to patients when they are initially treated for type 2 diabetes. It is made globally by numerous generic drugmakers. NDMA is known to cause cancer in animals and is classified as a possible human carcinogen.

The US Food and Drug Administration (FDA) said in a statement on Wednesday (December 4) that the agency is testing samples of metformin sold in the US for NDMA and that it will recommend recalls of the medication as appropriate.

“The agency is in the beginning stages of testing metformin,” said FDA spokesman Jeremy Kahn.

“However, the agency has not confirmed if NDMA in metformin is above the acceptable daily intake (ADI) limit of 96 nanograms in the US”

Kahn said diabetes is a serious condition and patients who take metformin shouldn’t stop taking their medication without first talking to their doctors.

Earlier on Wednesday, the European Medicines Agency (EMA) said companies should test for high levels of NDMA in metformin. No dangerous levels have been detected in EU supplies to date, and patients should continue taking their diabetes treatments as prescribed, the agency said in response to questions.

“Although the risk from NDMA seen so far has been very low, impurities such as NDMA should be avoided in medicines,” the EMA said.

Concerns about high levels of NDMA, which can form during some industrial processes, have been rising since it was found in blood-pressure medications and drugs containing ranitidine, the active ingredient in Sanofi’s Zantac for heartburn.


Category: Singapore

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