New Onset Hypertension Linked to Generic Cyclosporine Substitution in Post-Renal Transplant Patient

Abstract

This is case report and review of the literature focused on generic substitutions of cyclosporine and its consequences. The pharmacokinetics and pharmacodynamics of the generic substitutions are clear different than the parent compound Sandimmune and can lead to different outcomes, as was the case in this report. A detailed accounting of the patients history led to the discovery of the problem and sorting back to a the branded drug supported the hypothesis.

The Tyranny of Generic Immunosuppressants

“…First, a geometric mean, unlike an arithmetic mean, is a better measure of central tendency and lessens the effect of outliers [7] . Additionally, A 12-year study by the FDA on bioequivalence data showed that under the current system of approval for geIn this issue of the Journal, 2 important articles [1,2] add to the growing concern of the intrusion of generic immunosuppression medications into clinical transplantation practice. On the one hand, from a financial standpoint, generics will help control costs; on the other hand, they do create important clinical concerns, especially with pharmacy substitution unbeknown to the patient or physician.…”

“…The meaningful review of Tsipotis et al [1] efficiently outlines a meta-analysis of trials examining the bioavailability of generic versus branded immunosuppressive drugs. Al Dhaybi and Bakris [2] describe an interesting case report of new onset hypertension linked to a generic cyclosporine substitution in kidney transplant recipients.…”