The Ministry of Health, Wellness & The Environment (MoHWE) through the office of the Director of Pharmaceutical Services, Alfred Athill has been monitoring several challenges that have been affecting the pharmaceutical industry and more specifically, the recall of two (2) very popular medicines namely Ranitidine (Zantac) used to treat heartburn and other gastrointestinal challenges and Metformin (Glucophage) used to treat type 2 diabetes.
The recalls are due primarily to the presence of a “possible human carcinogen” known as N-nitrosodimethylamine (NDMA). NDMA is an environmental contaminant that is found in water and foods, including meats, dairy products, and vegetables. Consuming up to 0.096 micrograms or 0.32 parts per million (ppm) of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure.
This recall which has affected Metformin, is restricted to specific brands of the product and affects primarily the Extended Release (ER) formulations from specific manufactures.
The Food and Drug Administration (FDA), the European Medical Authority (EMA) and the Canadian Medical Authority (CMA) have been monitoring these products through their strict post marketing surveillance processes and continues to expand the list of recalled products once tests results reveal any compromise involving NDMA.
The MoHWE would like to advise ALL persons taking Metformin to continue taking their medication to prevent any dangerous health situations that may occur.
The recall of Ranitidine has affected all oral dosage forms and some specific brands/batch of the parenteral (injectable) dosage form, consequently it is important that alternative interventions be considered for all patients presently prescribed this medicine. It has been observed that the concentration of NDMA in these products increases even during storage conditions thereby exposing persons taking these products to increase levels of this “possible carcinogen”.
The health and safety of our twin island state remains the primary function of the MoHWE and consequently we will continue to advise the general public on matter that is of a public health concern. Persons presently taking any of the above medicines are advised to contact their health care provider.
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