KUWAIT, June 2: The Assistant Undersecretary for Drug and Food Control Affairs at the Ministry of Health, Dr. Abdullah Al-Badr, confirmed today, that the metformin product for treating diabetics used in Kuwait is safe, noting that the ministry continues to spend it on patients according to the applicable laws and regulations.
Al-Badr told Kuwait News Agency (KUNA) that the manufacturers of metformin preparations that the American Food and Drug Administration recently approached to withdraw its products because they contain a higher percentage of the permitted (NMMI) material were not registered with the Department of Registration and Control of Medicinal and Plant Medicines and were not traded in Kuwait.
Al-Badr pointed out that the pharmaceutical preparations containing metformin that are licensed to circulate in Kuwait are safe, recommending health practitioners to continuously prescribe them according to the rules and regulations followed, and patients should not stop using them except by consulting the attending physician.
He stated that the registered preparations did not prove to contain ratios higher than the permissible limit of this substance, which are potentially carcinogenic if exposed to them in quantities greater than the permissible limit and for long periods.
He added that the Drug Control Administration has been following closely since last December to evaluate all pharmaceutical preparations containing the substance (metformin) registered in the ministry in order to verify the proportions of the said substance to ensure its quality and safety.
The administration addressed the manufacturers of these products at the time to provide certificates of analysis for the active substance and the final product proving that the permissible percentage was not exceeded in addition to submitting a risk management plan to limit the formation of these impurities with pharmaceuticals.
Al-Badr indicated that if any medical preparations are found to contain ratios higher than the permissible limit, the administration will immediately issue a decision to withdraw them from the local market (KUNA)