Posted 11/27/2007] Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration.

A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Female patients of childbearing potential must receive contraceptive counseling and must use effective contraception while taking Myfortic. Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

If you or a loved one has taken Myfortic and lost a pregnancy or had a childe with congenital malformations then you should call us toll free now at 1-866-374-0338 because you may be entitled to medical monitoring and compensation from the manufacturer.

Get your free, no obligation claim review by a lawyer today. Call us at toll free 1-866-374-0338, or use the Free Claim Evaluation form to your right, or click on Live Support on the right of this page.

We have represented clients in every state and helped thousands of injured clients nationwide make recoveries for their injuries. We are ready to help you! Our clients are never at risk of paying any fees, expenses, or costs out of pocket. All fees costs and expenses are paid only out of any recovery we make for you.

Do not delay. Contact us now to find out if we can help. The claim evaluation is free. All claims have strict time limitations which will bar any recovery you or your loved may be entitled if the claim is not brought on time.

CALL NOW 1-866-374-0338

[November 2007 - Dear Healthcare Professional letter - Novartis]
[October 2007 - Label - Novartis]
Previous MedWatch Alert: [10/29/2007]