Mexico ALERT: Cofepris asks to stop ranitidine medications due to cancer risk

Cofepris asks to avoid the purchase of medicines containing Ranitidine and to consult with other health professionals other therapeutic options.

The Federal Commission for the Protection against Sanitary Risks (Cofepris) asked to suspend the consumption, manufacture, and commercialization of medicines with ranitidine, after confirming that it contains the impurity N-nitrosodimethylamine (NDMA), which increases the risk of developing cancer.

He also asked the medical staff not to prescribe medicines containing ranitidine, he was instructed by pharmacies and distributors to stop marketing them, and to the holders of the sanitary records to suspend the manufacture, distribution, and sale of those products.

On October 5, in a statement, Cofepris reported that it was evaluating the health risks to the health of the Mexican population due to the possible presence of the impurity N-nitrosodimethylamine (NDMA) in medicines containing ranitidine.

“N-nitrosodimethylamine in concentrations above the limit considered safe and during long periods of exposure may increase the risk of developing cancer,” said the agency.

However, at that time he indicated that, since there is insufficient evidence to suggest discontinuation of ranitidine treatments, “the risk of discontinuation is greater than that of probable exposure to NDMA.”

It was until today, in a second statement, that Cofepris asked to suspend the manufacture, marketing and consumption of drugs with ranitidine, based on the information shared through the Pharmaceutical Inspection Cooperation Scheme and the agencies’ information networks regulatory, as indicated.

He informed that “it is in communication with the holders of the medical records of the medications in Mexico, which in their formulation contain ranitidine, to establish the conductive measures that guarantee the safety of the product.”

Ranitidine is one of the most prescribed and used medications to treat ulcers, gastroesophageal reflux and those conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome; The over-the-counter product is used to prevent and relieve heartburn associated with acid indigestion.

In addition, Coepriss alerts and recommends not acquiring or using Mesofrance products

If you have purchased or used Mesofrance brand products, and have presented allergic reactions or injuries related to the use of such products, you must inform the Cofepris through e-reporting, available in the Pharmacovigilance section or in the email farmacovigilancia@cofepris.gob.mx

The State Commission for the Protection against Sanitary Risks of Sinaloa, Coepriss, replied the information issued by the Cofepris on the health alert related to the use of Mesofrance products since they have not been evaluated or approved for use by this Federal Commission.

Commissioner Jorge Alan Urbina Vidales reported that the risk associated with the use of “miracle products” is that they lack scientific evidence and there is not enough and necessary information to support the properties that the manufacturer himself attributes to his products, so both can not be considered as products that meet the conditions of quality, safety, and effectiveness for use.

He noted that Cofepris conducted an investigation based on information related to the use of Mesofrance products, a company that markets products for aesthetic purposes and attributes certain properties such as the removal of accumulated fat and skin rejuvenation.

“Cofepris has not authorized any of the products marketed by Mesofrance, which means that the quality, safety, and efficacy of these products is not approved by this Health Authority,” he said.

Urbina Vidales explained that the information that Mesofrance provides about its products suggests in its labeling and advertising that it serves as a remedy for one or several diseases quickly and promising great health benefits; related to weight loss or anti-aging treatments, in products such as Liposculptor, Gluteo Firm, Reductive Collagen, Fat Burner, Elixir Anti-Aging, among others.

Therefore, Urbina Vidales said that among the recommendations issued by Cofepris, it is worth noting to acquire or use any Mesofrance brand product, as well as any other health product that has not been authorized by Cofepris.

“If it is necessary to carry out any treatment for weight and / or aesthetic control, the population is recommended to go with duly authorized professional personnel who have the hygiene and safety measures for their care,” he said.

He said that Cofepris will continue to carry out health surveillance actions to prevent the sale of these products since they represent a health risk to the population.

Finally, he affirmed that if he has acquired or used products of the Mesofrance brand, and presented allergic reactions or injuries related to the use of said products, he must inform the Cofepris through e-reporting, available in the Pharmacovigilance section or in the email farmacovigilancia@cofepris.gob.mx

Source: Cofepris

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