Manufacturers required to test metformin-containing medications for possible carcinogen

AMMAN — Jordan's national drug watchdog has asked local manufactures and suppliers of metformin-containing extended-release products to test the medications for the nitrosamine impurity N-nitrosodimethylamine (NDMA), a possible cancer-causing chemical.

The move comes after the US Food and Drug Administration recalled batches of metformin-containing drugs, mainly diabetes medications, after finding high levels of the carcinogen in some extended-release formulations of the drugs, the Jordan News Agency, Petra, reported on Friday.

Director of the Jordan Food and Drug Administration (JFDA) Nizar Mheidat, told Petra that the administration asked the manufactures and suppliers of metformin-containing extended-release products earlier this year to test the medications they manufacture and import, either registered or undergoing registration processes, for the NDMA impurity.

Suppliers and manufactures were also ordered to test all metformin batches in the Jordanian market for the impurity and ensure that its concentration levels are at acceptable global thresholds, he said.

Mheidat noted that “none of the metformin batches that were recalled in the US are registered in Jordan”, as the US watchdog's recall decision targets a limited number of manufacturers and the tablet version of the drug.

According to Mheidat, many other world countries are still testing the metformin-containing extended-release products for the NDMA impurity, and the same is being done by the JFDA.

He said that patients should not stop using metformin, but only after consulting with their healthcare professionals.