By: Andrea Castillo
On January 6, 2023 the Department of Regulation and Control of Pharmaceutical and Related Products of Guatemala issued the communiqué Jef. DRCPFA. 01-2023 on the cancellation of sanitary registrations and the withdrawal of pharmaceutical products with the active ingredient Ranitidine.
This decision arises from the alerts and suspension recommendations issued by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the safety of the oral drug, due to the presence of the impurity Nitroso Dimethyl Amine (DNMA).
Ranitidine is indicated for the treatment of peptic, gastric, and duodenal ulcers, and gastroesophageal reflux diseases, among others. Although the exact origin of the impurity has not been determined, it is probable that the substance Nitroso Dimethyl Amine (DNMA) is formed when it is metabolized in the intestinal tract or by degradation under normal storage conditions. This substance has been classified as a potent mutagenic carcinogen in animals and exposure to high levels could increase the risk of cancer in humans.
Considering the risk-benefit ratio and in order to guarantee the safety and efficacy of the medicines for the Guatemalan population, the Department of Regulation and Control of Pharmaceutical and Related Products issues the following provisions:
- Cancellation of sanitary registrations and withdrawal of products containing Ranitidine administered orally in Guatemala.
- Holders of sanitary registrations of products containing Ranitidine administered orally must suspend the importation, manufacture, distribution, and sale of these products, as of the date established in the notification.
- The only authorized route of administration will be parenteral Ranitidine, accepting only presentations for hospital and institutional use. The holders of the sanitary registrations of these products must update the sanitary registrations within 3 months from the publication of the notice.
- Medicines with Ranitidine administered parenterally will be subject to risk-benefit evaluations.
Additionally, it is recommended to consult with the physician about alternatives for the treatment of ulcers and related diseases.