DUBAI 24 September 2019: The Ministry of Health and Prevention (MoHAP), has issued a circular to all health facilities and practitioners, informing them about the precautionary suspension of the registration, import and distribution of all medicines containing ranitidine.
Yet, the ministry said it will not withdraw these medicines until the acceptable ratio of NDMA is established by international health authorities.
The ministry’s decision is based on the recommendations of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Health Canada regarding the possible contamination of the medicine with NDMA impurity (N-nitrosodimethylamine), which is classified potentially carcinogenic to human based on laboratory tests.
In the circular, which was signed by Dr. Amin Hussain Al Amiri, the Ministry’s Assistant Under-Secretary for Public Health Policy and Licensing, and Chairman of the Supreme National Pharmacovigilance Committee, the ministry said it does not recommend patients to stop taking ranitidine, which is used to treat and prevent ulcers and acidity in the stomach.
The circular called on patients wishing to stop taking ranitidine due to possible contamination, to consult a healthcare professional for replacement, in line with the recommendation of the international drug agencies. Yet, a number of ranitidine-containing products are registered with the Drug Department of the ministry.
Dr. Ruqaya Al Bastaki, Director of MoHAP’s Drug Department, said that the circular was issued after reviewing measures taken by international health authorities, including the FDA, the EMA, and Health Canada.
She called on patients to contact the ministry in the event of any side effects arising from using the above-mentioned products, via phone: 04 04 2301448, e-mail: email@example.com, or through the ministry’s website or the mobile application: UAERADR.