In February, the U.S. FDA said it had not found that N-nitrosodimethylamine (NDMA) exceeded the standard in metformin, a commonly used diabetes drug. This week, however, things reversed.
Recently, the FDA announced that after testing the sustained-release metformin drugs, it found that the NDMA level in some metformin products was higher than the acceptable daily intake of human body regulated by the regulatory authority. NDMA is also the root cause of the recall of high blood pressure and heartburn drugs in the United States. U.S. regulators say they are in contact with companies that make the drug in order to initiate a drug recall.
Metformin is a common drug used to control blood glucose in patients with type 2 diabetes mellitus. Bloomberg said in its report that about 21 million prescriptions were used for sustained-release versions of the drug last year, accounting for about a quarter of all metformin prescriptions in the United States. The recall of metformin is expected to start this week, Bloomberg said.
FDA spokesman Sarah peddicord said that the rapid release form of metformin did not show carcinogen levels higher than normal.
On Thursday (May 28), the FDA announced it had recommended that five pharmaceutical companies voluntarily recall metformin, a sustained-release drug for diabetes. The FDA said it would publish specific recall notices on its website, and disclosed that one of them was metformin tablets from Apotex Corp, a Canadian company, while the other four companies had not yet disclosed it. But the FDA also reminded consumers that even in the event of a recall, patients should continue to take metformin tablets until medical professionals help find alternative drugs.