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Bahrain issues list of approved Metformin medicines

MANAMA, June 2, 2020

Bahrain's National Health Regulatory Authority (NHRA) said that it has issued a list of Type 2 diabetes medicines (containing Metformin) that are free or within acceptable limits of  carcinogenic impurity N-nitrosodimethylamine (NDMA). 
 
Based on lab analysis results declared in the SFDA announcement on May 29, NHRA said that the following registered diabetes medicines in Bahrain containing Metformin are free from the carcinogenic impurity N-nitrosodimethylamine (NDMA) or within the acceptable limits for daily consumption: Actosmet 15/850MG – 56, Glucophage 500MG – 50, Janumet 1000/50MG – 56, Kombiglyze XR 5/500MG – 30, Kombiglyze XR 5/1000MG – 30, Kombiglyze XR 2.5/1000MG – 60, Omformin 500MG – 20, Omformin 500MG – 1000, Synjardy 5/850MG - 60 Synjardy 5/1000MG – 60, Synjardy 12.5/850MG – 60, Synjardy 12.5/1000MG – 60, Xigduo XR 5/500MG - 30 Xigduo XR 5/1000MG – 60, Xigduo XR 10/500MG - 30 and Xigduo XR 10/1000MG - 30, a Bahrain News Agency report said.
 
The NHRA added that it gave pharmaceutical companies a 72-hour grace period to have the laboratory results of other drugs not included on the published list checked and prove their safety. The list, posted on the NHRA website and Instagram account, will be updated accordingly, NHRA said.
 
In its statement, the NHRA advised all health care professionals neither to prescribe nor to dispense any medicine containing Metformin not mentioned on the list.
 
NHRA said it has suspended and prohibited the importation of all other Metformin containing medicines until it finalises the investigations to make sure that the rest of these medicines are free from the carcinogenic impurity (NDMA) or within the acceptable limits for daily consumption.
 
Patients are urged to check whether their medications are included on the list of permitted drugs and to consult with their doctors if they are not mentioned, the NHRA said.



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