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    30-May-2020

JFDA asks metformin-containing drugs' suppliers to test medications for NDMA impurity

 

Petra

 

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 U.S. Drug and Food Administration recalled batches of metformin-containing drugs, mainly diabetes medications, after finding high levels of the carcinogen beyond the acceptable global intake limits in some extended-release formulations of the drugs.
 
Director of the Jordan Drug and Food 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 under registration, for the NDMA impurity.
 
He added that the suppliers and manufactures were also ordered to test all metformin batches in the Jordanian market for the impurity and ensure its concentration levels are at acceptable global thresholds.
 
Mheidat indicated that none of the metformin lots, which were recalled in the US, is registered in Jordan, noting that 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 were still testing the metformin-containing extended-release products for the NDMA impurity, and the same is being done by the JFDA.
 
He said patients should not stop using metformin, but only after consulting with their healthcare professionals.
 
 

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