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(HealthNewsDigest.com) – A new study published in the American Journal of Transplantation reveals that substitution of a brand name immunosuppressive drug with a generic (manufactured by Sandoz) for preventing rejection of transplanted organs appears to be safe for transplant recipients.
Tacrolimus is an immunosuppressive drug that is used to prevent rejection of transplanted organs following organ transplantation. In August 2009, another pharmaceutical company received approval from the FDA for a generic tacrolimus product.
In the first formal study of its kind, Raman Venkataramanan, PhD, of the University of Pittsburgh, School of Pharmacy and School of Medicine, and researchers analyzed database information regarding tacrolimus concentrations and indices of liver and kidney function before and after generic substitution in 48 liver and 55 kidney transplant recipients.
Substitution of brand name tacrolimus product with the generic formulation resulted in an average reduction of 15.9% and 11.9% in concentration/dose ratio in clinically stable liver and kidney transplant patients, respectively. The substitution was safe, as no changes occurred in liver or kidney function and no acute rejection episodes occurred during the follow-up time period.
An accompanying editorial by G.B. Klintmalm of Baylor University Medical Center, while offering a different viewpoint, also calls upon the FDA to change the requirements for approval of these drugs in order for the transplant community to trust and rely on generic immunosuppressive drugs for the treatment of transplant recipients.
Klintmalm notes that “in order to safely save healthcare dollars, it is urgent that the FDA step up to the plate to implement changes in its approval process for generics of critical-dose drugs.”
“Our findings suggest that transplant patients currently taking the brand name tacrolimus formulation may be safely switched to the generic product,” Venkataramanan concludes. “However, on an individual basis, since some patients had significant changes in tacrolimus blood levels, increased monitoring of tacrolimus blood levels is necessary following the substitution to assure adequate drug concentrations. Long-term use of generic product will lead to cost savings.”
This study is published in the American Journal of Transplantation. Media wishing to receive a PDF of the article or editorial may contact [email protected]
Full citation: Venkataramanan et al. The Impact of Conversion From Prograf to Generic Tacrolimus in Liver and Kidney Transplant Recipients With Stable Graft Function. American Journal of Transplantation; http://doi.wiley.com/10.1111/j.1600-6143.2011.03615.x
Editorial: Klintmalm et al. Immunosuppression, Generic Drugs and the FDA. American Journal of Transplantation; http://doi.wiley.com/10.1111/10.1111/j.1600-6143.2011.03616.x
About the Author: Raman Venkataramanan, PhD, is affiliated with the University of Pittsburgh, School of Pharmacy and School of Medicine.
To arrange an interview with an author, please contact Dr. Venkataramanan at [email protected].
About the Journal
American Journal of Transplantation (AJT) is the official journal of the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). This #1 ranked transplantation journal serves as a forum for debate and re-assessment and is a major new platform for promoting understanding, improving results and advancing science in this dynamic field. Published monthly, AJT provides an essential resource for researchers and clinicians around the world. Find out more at www.amjtrans.com. NEW! Download the AJT mobile app for free to your smart phone or iPad at www.amjtrans.com/app and keep up with the latest research published in American Journal of Transplantation.
About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world’s leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world’s most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.
The Publisher, the American Society of Transplantation and the American Society of Transplant Surgeons, and Editors cannot be held responsible for errors or any consequences arising from the use of information contained in this journal; the views and opinions expressed do not necessarily reflect those of the Publisher, the American Society of Transplantation and the American Society of Transplant Surgeons, and Editors, neither does the publication of advertisements constitute any endorsement by the Publisher.
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