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, importation, and distribution of all medicines containing ranitidine.
However, the announcement also noted that it will not withdraw these medicines until the acceptable ratio of NDMA is established by international health authorities.
Health Ministry Bans Registration, Supply, and Distribution of Medicines Containing Ranitidine
The ministerial decision was 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, as shared in a report by WAM.
Based on a circular 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, it also said that the ministry does not recommend patients to stop taking ranitidine, which is used to treat and prevent ulcers and acidity in the stomach.
It also explained that 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. However, a number of ranitidine-containing products are registered with the Drug Department of the ministry.
The Health Ministry also pointed out that it maintains a constant dialogue with the local and international pharmaceutical manufacturers, and international pharmaceutical authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The Ministry noted that once any warning in relation to medicines is issued, the ministry will immediately release a circular to all health and concerned authorities, highlighting the need to withdraw and dispose of certain products in order to safeguard the health and safety of the community.
The ministry explained that it also does take preventive measures and follows up on the implementation of mandates of the circulars, as part of its strategy to build quality assurance, therapeutic, health, and pharmaceutical safety systems according to international standards.
Commenting on the ministerial update, 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.
Dr. Al Bastaki urged patients taking medications containing the said drug 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: firstname.lastname@example.org, or through the ministry’s website or the mobile application (UAERADR) facilities.