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View Full Version : New FDA Warnings on CellCept



Annie
5.19.08, 5:25 AM
The Food & Drug Administration issued new warnings last Friday (March 16, 2007) for pregnant women about the immune system suppressing drugs "CellCept" and "Myfortic". A notice from the FDA went out last October, (2007) about these drugs and a connection between these drugs and serious birth defects but apparently more evidence has been coming since then.
The medicines from Roche and Novartis, respectively, are prescribed to organ transplant patients to help avoid rejection of a transplanted organ. The FDA says that it "is aware of reports of infants born with serious congenital anomalies" particularly of the ears and/or mouth, following exposure to the active components of CellCept and Myforic.
They note that, in most cases, the mothers were taking the drugs following an organ transplant but that some mothers were taking one or the other "for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme". The drug therapies began before their pregnancies and continued into the first trimester or until the pregnancy was detected. Both CellCept and Myforic will increase the risk of spontaneous abortion in the first trimester and, in the language of the FDA, "can cause congenital malformations in the offspring of women who are treated during pregnancy".
In other words, if you and your doctor are going to try one of these for your lupus, you need to be positive that you are not pregnant before or during the treatment.



More... (http://www.Coffeerooms.com/lupus/2008/05/new_fda_warning.html)