The Ministry of Health and Prevention, MoHAP, announced that it has taken all necessary measures and precautions to make sure that the pharmacies don’t have two batches of metformin tablets, 500 mg, due to the presence of NDMA which is classified a probable human carcinogen, based on the results of laboratory tests.
In a statement, the Health Ministry explained that the decision comes in line with the circular issued by the FDA after having received a notice from the manufacturing company “Nostrum Laboratories” indicating that it has voluntarily recalled the two batches, underlining that the drug is not registered in the UAE and hasn’t entered the country after having checked the official import system.
Metformin is a prescription drug and is found in several medications that are used to treat type 2 diabetes.
Instructions to all concerned parties
HE Dr. Amin Hussein Al Amiri, the Assistant Undersecretary of the Ministry of Health and Prevention’s Public Health Policy and Licenses, advised patients not to stop taking Metformin tablets except under the supervision of their attending physicians, calling doctors to prescribe metformin as usual, until they get updated information from MoHAP.
“MoHAP has issued a circular earlier to the manufacturing companies of metformin to provide a complete analysis report of the active ingredient and the final product. The analysis should be conducted in an accredited laboratory, while adopting the recommendations of the FDA in terms of the NDMA impurity testing and analysis. This comes as part of the ministry’s strategy to build quality and safety for therapeutic, healthcare, and pharmaceutical systems according to international standards,” added Al-Amiri.
MoHAP’s circular also required all suppliers of metformin products to submit a certificate of analysis proving that their products are free of NMDA impurities prior to importing them from abroad.
Communication with global drug authorities
Al-Amiri went on to say: “The Ministry deals with any drug-related circulars, warnings, and updates issued by global health authorities, Where it immediately issues a circular to all health authorities and other concerned bodies if there is a need to recall these products or destroy them to maintain the health and safety of community members.”
He urged the individuals to report any side and adverse effects through the electronic system on the ministry’s website or via email: pv@mohap.gov.ae , or through the smart app “UAE RADR”, noting that all the issued circulars are publicly available on MoHAP’s website.