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.
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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 ? https://t.co/pTqC6bjtVI @SSalud_mx pic.twitter.com/XovvYejLgU
— 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.
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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.
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