The National Agency for Regulation, Control and Sanitary Surveillance (Arcsa) of Ecuador reported that it had decided to suspend the sanitary registrations of all medicines for human use that are marketed in Ecuadorian territory and contain the active ingredient ranitidine.
This decision —since Tuesday it appears in resolution No. Arcsa-CGTC-00053-2022-JPFJ— is given because there are “recommendations from the European Medicines Agency (EMA) due to the presence of the impurity N-nitrosodimethylamine (NDMA ) and the conditions proposed to the MAH (Marketing Authorization Holder), until compliance with the guide ‘Control of impurities of N-nitrosamines in human drugs’, of the Food and Drug Administration (FDA) of the United States”.
According to the institution’s explanation, ranitidine is part of the drugs known as H2 blockers (histamine-2), as it blocks histamine receptors in the stomach and reduces the production of stomach acid. For this reason, it has been used in the treatment of heartburn and ulcers for approximately 30 years.
“Nitrosamines are organic compounds that we are exposed to in our daily lives. They are found in low levels in water and food, including meats, vegetables, and dairy products. Nitrosamines result from chemical reactions and can form as impurities in drugs during manufacturing. In particular, it has been detected that one of them, N-nitrosodimethylamine (NDMA), is potentially carcinogenic”, indicates the Arcsa statement.
The institution mentions that in the country there are 61 drugs that use the active ranitidine, of which 27 are manufactured locally.
Laboratories that sell these products in Ecuador —produced or imported— must compulsorily and immediately withdraw them to prevent problems. (I)
Source: Eluniverso
Paul is a talented author and journalist with a passion for entertainment and general news. He currently works as a writer at the 247 News Agency, where he has established herself as a respected voice in the industry.
