Featured Research

from universities, journals, and other organizations

Substitution of brand name with generic drug appears to be safe for transplant recipients, study suggests

Date:
September 13, 2011
Source:
Wiley-Blackwell
Summary:
New research 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.

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.

Related Articles


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."


Story Source:

The above story is based on materials provided by Wiley-Blackwell. Note: Materials may be edited for content and length.


Cite This Page:

Wiley-Blackwell. "Substitution of brand name with generic drug appears to be safe for transplant recipients, study suggests." ScienceDaily. ScienceDaily, 13 September 2011. <www.sciencedaily.com/releases/2011/09/110913111407.htm>.
Wiley-Blackwell. (2011, September 13). Substitution of brand name with generic drug appears to be safe for transplant recipients, study suggests. ScienceDaily. Retrieved February 26, 2015 from www.sciencedaily.com/releases/2011/09/110913111407.htm
Wiley-Blackwell. "Substitution of brand name with generic drug appears to be safe for transplant recipients, study suggests." ScienceDaily. www.sciencedaily.com/releases/2011/09/110913111407.htm (accessed February 26, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Thursday, February 26, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Sleeping Too Much Or Too Little Might Increase Stroke Risk

Sleeping Too Much Or Too Little Might Increase Stroke Risk

Newsy (Feb. 26, 2015) People who sleep more than eight hours per night are 45 percent more likely to have a stroke, according to a University of Cambridge study. Video provided by Newsy
Powered by NewsLook.com
London Show Dissects History of Forensic Science

London Show Dissects History of Forensic Science

AFP (Feb. 25, 2015) Forensic science, which has fascinated generations with its unravelling of gruesome crime mysteries, is being put under the microscope in an exhibition of real criminal investigations in London. Duration: 00:53 Video provided by AFP
Powered by NewsLook.com
Michigan Couple Celebrates Identical Triplets

Michigan Couple Celebrates Identical Triplets

AP (Feb. 25, 2015) A suburban Detroit couple who have two older children are adjusting to life after becoming parents to identical triplets _ a multiple birth a doctor calls rare. (Feb. 25) Video provided by AP
Powered by NewsLook.com
Mayor Says District of Columbia to Go Ahead With Pot Legalization

Mayor Says District of Columbia to Go Ahead With Pot Legalization

Reuters - News Video Online (Feb. 25, 2015) Washington&apos;s mayor says the District of Columbia will move forward with marijuana legalization, despite pushback from Congress. Rough Cut (no reporter narration). Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins