Iranian firm dismisses reports Canada-licensed diabetes drug could be risky

An Iranian pharmaceutical company producing diabetes drugs under a license from a Canadian company has rejected claims it should recall its medication from the market because of high levels of a possible cancer-causing impurity, saying patients can use the drugs freely.

According to Press TV, the Rasta Imen Daroo, a company representing Canada’s Apotex Corp in Iran, said in a Sunday statement that metformin tablets planned to be supplied by the company to the Iranian market are free carcinogen N-nitrosodimethylamine (NDMA).  

The statement came after the US Food and Drug Administration (FDA) recommended that Apotex and one of its firms recall their metformin tablets because they have high levels of NDMA.

However, Rasta Imen Daroo said tablets it is planning to produce under Apotex license are not of the “extended release” type designated by the FDA as containing NDMA beyond acceptable levels.

It said the tablets are instead of the “immediate release” type endorsed by the FDA as safe, adding that diabetic patients could use the medication without any fear about the possible risks associated with the carcinogen.

ME