Morocco’s Ministry of Health has officially withdrawn Ranitidine-containing medicines from the market.
Rabat – The Moroccan Directorate of Medicines and Pharmacy of the Ministry of Health ordered on Wednesday, September 25, the withdrawal of ‘Ranitidine‘ medicines after tests showed that they contained the substance N-nitrosodimethylamine (NDMA).
The directorate acted based on reports from foreign pharmaceutical agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), said the Health Ministry in a statement on Wednesday.
The reports indicated that the substance has carcinogenic effects. Ranitidine is often used in H2 blockers to reduce the amount of acid produced in the stomach of patients with conditions such as heartburn and stomach ulcers.
The department added that it is conducting the necessary investigations into Ranitidine-containing medicines. The ministry aims to ensure compliance with international standards set by the National Medicines Control Laboratory, accredited by the World Health Organization (WHO) and the European Directorate for the Quality of Medicines and Health Care (EDQM).
“NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies,” said EMA in a statement.
“It is present in some foods and in water supplies but is not expected to cause harm when ingested in very low levels,” explained the statement.
In the US, 14 batches have already been withdrawn, following a press release by Sandoz Inc, on September 23, indicating the presence of N-nitrosodimethylamine (NDMA) in certain gastric drugs.
In Morocco, Ranitidine is sold under the trade names ACIDAC, PEP-RANI-AZANTAC-RANIMAT, EFITAC- RANITIL-ZANTAC, NORMACIDE.
It is commonly used in the treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. There is also tentative evidence of benefits for people suffering from hives.
In the past few years, the cancer mortality rate has increased in Morocco, especially in cases of cervical cancer. In 2018, a total of 2,465 women died of cervical cancer, out of the 13.2 million women in Morocco.
The number of deaths from cervical cancer per year nearly doubled in the country between 2012 and 2018, increasing from 1,076 to 2,465, according to the MENA coalition for HPV Elimination and the Tunisian Center for Public Health.