San José, Costa Rica, since 1956

Health Officials Deny Medicine Caused Deaths

IN spite of alarm raised to the contrary,generic medicine prescribed to kidneytransplant patients is safe, top officials ofthe Social Security System (Caja), whichprovides cradle-to-grave health care tomost Costa Ricans, said this week.The Costa Rican Kidney Foundation(FUNCORE) blamed the deaths of fivekidney transplant patients on a failure ofthe generic version of the immunosuppressive(anti-rejection) drug cyclosporin, instatements to the press Tuesday.Caja officials held a press conferencethe next day with doctors, officials, scientistsand a patient who uses the genericversion of the drug, who is also a Cajadoctor, to address the allegations.“None of the kidney transplant patientswho have died, died because ofcyclosporin,” said Dr. Alberto Sáenz,executive president of the Caja, at the conferenceWednesday.DOCTORS were careful to mentionthat all organ transplants could be rejectedby the human body, and the generic drughas been approved by the U.S. Food andDrug Administration (FDA) and complieswith Costa Rican drug standards.FUNCORE’s statement cited a preliminarystudy of generic cyclosporin by theCaja that documented the rejections oftransplants and deaths of some patients.Caja officials disputed the conclusion thatthe deaths were from use of the drug andalso that the results of the study are accurate,since it is only preliminary. The finalstudy may be released to the public nextweek, according to the Caja.Costa Rica is first among LatinAmerican countries in numbers of transplantsrelative to population size, Sáenzsaid, adding its program is “extremely successful.”THE Caja has administered the genericversion of the drug to kidney transplantpatients who began treatment in January2003; those who began treatment beforewere given the original version, and mostof them continue taking it – only a fewhave switched to the generic, according toDr. Albin Chaves, in charge of the Caja’spharmaceutical therapy department.Dr. Manuel Cerdas, a nephrologist (adoctor trained in kidney diseases, transplantationand dialysis therapy) with thepublic Hospital México, said the genericversion of the medicine has been proven“as safe and effective as the original.”The rate of kidney rejection here isapproximately 25%, which is about thesame as worldwide rates, Cerdas said.Most of those who rejected their transplantswere rescued, he added.“CONCERNING the deaths ofpatients, they were given autopsies and thecause of death was cardiovascular problemsand infection. An exhaustive analysisof these cases didn’t show any linkbetween the deaths of the patients and useof the medicine in question,” he said.“There is no link, and it’s importantthat be made clear,” he concluded.

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