translated from Spanish: Cofepris alert for contaminated ranitidine; discards suspension

Cofepris warned that it assesses health risks in medicines containing the active substance ranitidine that are marketed in Mexico, by the possible presence of The N-nitrosodimethylamine (NDMA) impurity, which may increase the risk of developing cancer .
The health authority acknowledged that at the moment it does not have sufficient evidence to suggest discontinuation of ranitidine treatments and at this time the risk of stopping it is higher than that of likely exposure to NDMA.
Read more: CNDH issues recommendation to IMSS for dealing with a woman with diclofenac and causing her death
He added that in Mexico there were other treatment alternatives authorized by the Federal Commission for the Protection of Health Risks (Cofepris) for the same uses of ranitidine, so he recommended consulting with the doctor about these other options.

#Comunicado ? The @Cofepris reports on the products containing the active substance in its formulation called #Ranitidina ? @SSalud_mx
— COFEPRIS (@COFEPRIS) October 6, 2019
In a statement, he indicated that this ndMA alert was taken from information agreed with collaboration with the International Regulatory Agencies members of the Pharmaceutical Inspection Cooperation Scheme (PIC’s) and with the Latin American Pharmacovigilance.
He detailed that N-nitrosodimethylamine in concentrations above the limit considered safe and during long periods of exposure, can increase the risk of developing cancer.
Find out: Cofepris suspends cancer drug producers for not being certified
Since September, the U.S. Food and Drug Administration (FDA) has issued a warning about the risk of NDMA cancer in ranitidine.
In response, the Panamanian government decided to withdraw medicines with this substance «responsibly and as a precautionary measure».
Ranitidine, which is sold without a prescription, is indicated for the treatment of heartburn, gastritis, ulcer and gastroenteritis, among others.
What we do in Animal Político requires professional journalists, teamwork, dialogue with readers and something very important: independence. You can help us keep going. Be part of the team.
Subscribe to Animal Politician, receive benefits and support free journalism.#YoSoyAnimal

Original source in Spanish

Related Posts

Add Comment