Substitution of brand name with generic drug proves safe for transplant recipients

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 . 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 .

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 , respectively. The substitution was safe, as no changes occurred in liver or 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 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."

add to favorites email to friend print save as pdf

Related Stories

Recommended for you

Boxed warnings are common in novel therapeutics

Aug 19, 2014

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

AstraZeneca says DOJ closes probe into drug trial

Aug 19, 2014

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.

Perampanel for epilepsy: Still no proof of added benefit

Aug 19, 2014

The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment ...

User comments