Replacing Brand Name Drugs With Generic Ones Has Been Proven Safe For Recipients

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Replacing Brand Name Drugs With Generic Ones Has Been Proven Safe For Recipients Of Transplants

15 Sep 2011   

Substituting a brand name immunosuppressive drug with a generic (manufactured by Sandoz) to prevent rejection of transplanted organs appears to be safe for transplant recipients according to a new study published in the American Journal of Transplantation.

Tacrolimus, an immunosuppressive drug is designed to prevent rejection of transplanted organs following organ transplantation. The FDA approved a generic tacrolimus product from another pharmaceutical company.

Raman Venkataramanan, PhD, of the University of Pittsburgh, School of Pharmacy and School of Medicine, and his team analyzed data regarding tacrolimus concentrations and evidence of liver and kidney function before and after generic substitution. In the first study of its kind they evaluated 48 liver and 55 kidney transplant recipients.

When substituting a brand name tacrolimus product with the generic formulation resulted they discovered an average reduction of 15.9% (Brand) and 11.9% (Generic) in concentration/dose ratio in clinically stable liver and kidney transplant patients. Due to unchanged liver or kidney function and with no acute rejection episodes occurring during the follow-up time period the substitution was declared to be safe.

Although G.B. Klintmalm of Baylor University Medical Center has a different view, he suggests in an accompanying editorial that the FDA changes its requirements for approval of these drugs to gain more confidence from the transplant community to rely on generic immunosuppressive drugs for the treatment of transplant recipients.

Klintmalm comments:

"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."


Venkataramanan adds in a concluding statement:

"Our findings suggest that transplant patients currently taking the brand name tacrolimus formulation may be safely switched to the generic product. 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."


Written by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Article URL: http://www.medicalnewstoday.com/articles/234480.php

Main News Category: Transplants / Organ Donations


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[Chris]

I'm still sticking with brand name and my center wants me to stick with brand name Prograf since I have had my transplant for so long.. Generics I have been on keep getting switched to different companies, sometimes back and forth and I have to deal with side effects from the change which I hate. This happens with local and mail order pharmacy and the only solution is to shop around other local pharmacycompanies.
 
More blood test is not the best answer when there is only one good spot the labs can use and the scar tissue is building more and more.