From the editorial
Newspaper La Jornada
Wednesday, February 15, 2023, p. fifteen
Due to reports by therapeutic ineffectiveness
Yesterday, the Federal Commission for the Protection against Sanitary Risks (Cofepris) ordered health professionals not to supply or prescribe the tacrolimus immunosuppressant Octralin, and asked pharmacies to immobilize the product so that it is not sold.
This drug from Laboratorios Raam de Sahuayo is supplied to patients with liver, kidney and/or heart transplants to prevent organ rejection. This is one preventive measure against notifications through the pharmacovigilance system
and detailed what counts with 56 reports indicating a low concentration of tacrolimus in the blood indicating its therapeutic ineffectiveness
.
Given these risks to the health of transplant patients, the health authority, in strict adherence to articles 397, 404 sections X, XII and XIII, and 414 of the General Health Law, instructed medical professionals not to continue with the use or prescribe more Octralin in its two presentations of 1.0 milligrams and 5.0 milligrams, until this health authority concludes the investigation
.
The alert is issued solely and exclusively for dissemination purposes and is addressed to the general population, therefore it does not represent a resolution that authorizes, extends, or revokes health authorizations or represents a definitive pronouncement that involves the imminent imposition of administrative sanctions or measures. preventive or corrective security.
He recommended that patients, if they are under treatment with tacrolimus from said laboratory, see their doctor to look for therapeutic alternatives.
“Medical personnel must notify adverse reactions and discomfort after the supply of Octralin through email: [email protected]”.
He requested the support of pharmacies and distributors that in case of having the aforementioned product in store, it must be immobilized until it determines what is appropriate.
