Of the many issues that kidney transplant patients have to face, one of the most serious is the possibility that their body will reject the new organ. There are several drugs that may be prescribed to suppress a patient’s immune system and therefore, allow the new kidney to be accepted. Recently, the recommendations for using one of these common drugs, Myfortic, have changed.

The Food and Drug Administration (FDA) oversees the regulation of all legal drugs with approved medical uses in the United States. One of the tasks performed by the FDA is to evaluate a medication and determine its risk to pregnant women. The FDA originally determined that it could not rule out the risk of fetal harm by Myfortic. The FDA has upgraded Myfortic’s classification to the more serious category of there being positive evidence of fetal risk.

Specifically, the drug’s manufacturer, Novartis, and the FDA have issued warnings that the use of Myfortic during pregnancy has been associated with increased risks of first trimester pregnancy loss as well as congenital malformations. These malformations include abnormalities of the ear, face, limbs, heart, esophagus, and kidneys. The warnings advise that Myfortic should not be used by any patient who is planning a pregnancy unless she cannot be successfully treated with other immunosuppressant drugs.

Furthermore, healthcare professionals who are dealing with transplant patients are directed to share information about Myfortic’s risks with all of their female patients that have the potential to become pregnant. These patients must receive contraceptive counseling and must use effective contraception while taking Myfortic.

If you or someone you love has suffered the heartbreak of pregnancy loss or birth defects after taking Myfortic, you should consult an attorney to discuss your legal options. Our experienced attorneys understand pharmaceutical liability. Brown & Crouppen has represented many people who have been injured by defective drugs, and as our client, you will be backed by a team of legal professionals, medical experts, and investigators who are dedicated to ensuring that your rights are protected.

The attorneys at Brown & Crouppen can help you make informed decisions about your legal rights. Call us Toll-Free: 1-866-991-4700 for your free legal consultation or save time with our online Contact Form.