NHRA lists diabetes medicines free from carcinogenic impurity
TDT | Manama
The National Health Regulatory Authority (NHRA) issued yesterday a list of the registered diabetes medicines in Bahrain (containing Metformin) that are free from the carcinogenic impurity N-nitrosodimethylamine (NDMA), or within the acceptable limits for daily consumption.
Based on the lab analysis results declared in the Saudi Food and Drug Authority (SFDA) announcement last week, the NHRA’s list included: 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.
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 proven for safety. The list, posted on the NHRA website and Instagram account, will be updated accordingly, the NHRA noted.
In its statement, the NHRA advised all health care professionals neither to prescribe nor to dispense any Metformin containing medicine 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.