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Label Changes for Immunosuppresant Drugs

By Oguz Ozdemir

On July 14, 2009 the Food and Drug Administration has requested that the makers of specific immunosuppressant drugs update their labels to warn patients of an increased risk of latent and viral infections. Some of these infections include the BK virus-associated nephropathy.

Immunosuppressant drugs are used by organ transplant patients and are also referred to as anti rejection drugs. One immunosuppressant drug, tacrolimus, that is marketed as Prograf, has been shown to cause patients to develop the BK virus which is associated with nephropathy.

The drugs that are required to update their labels are: Sirolimus sold as Rapamune, Cyclosporine sold as Sandimmune as well as in generic forms, Mycophenolate mofetil which is sold as Cellcept as well as in generic forms, and Mycophenolic acid which is sold as Myfortic.

The problems resulting from the use of these immunosuppressant drugs has been found in renal or kidney transplant patients. The nephropathy can lead to loss of the transplanted kidney. If you have received an organ transplant and currently use immunosuppressant medications to control the rejection of the transplanted organ you should contact your physician to see if you are at risk of infection.

Transplant patients should be monitored on a regular basis to detect the potential of serious infection and early detection of possible latent viral infections. The FDA has required the manufacturers of these anti rejection drugs to update their labels to reflect the possibility of these serious viral infections. The FDA is continuing its review regarding the safety of these anti rejection drugs and has urged patients and health care professionals to report any side effects that occur as a result of these medications.

As soon as the risks involved with the use of Prograf were discovered the labels included with the medication reflected these side effects. The FDA is now requiring the above listed immunosuppressant drugs to upgrade their labels to include the risk of infections and the possibility of putting the transplanted organ at risk.

If you or someone you know is a transplant recipient, especially a kidney transplant, and are currently using immunosuppressant drugs to control the rejection of your transplanted organ you may want to speak with your physician and revise your anti rejection drug therapy. You may also want to contact the Napoli Bern Ripka Law Firm for help in handling this situation. Our lawyers can help you determine the best course of action to take.

If you live in New York you can make an appointment to come to our office which is located in the Empire State building. We also have offices throughout the country. We are committed to helping our clients realize the justice that they deserve.

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Originally posted at InjuryBoard by Oguz Ozdemir

Full post as published by New York City Personal Injury Lawyer on July 28, 2009 (boomark / email).