Mycophenolic acid (or mycophenolate) is primarily used to prevent rejection in renal (kidney) transplantation, although it is also used in liver, heart, and lung transplants. And due to its superior immunosuppressive maintenance therapy over cyclophosphamide in terms of response and side effects, it has also been used in treating lupus nephritis and certain immune-mediated disorders, such as psoriasis (a chronic condition characterized by red patches of skin covered with gray-white flakes), immunoglobulin A nephropathy (also known as Berger disease), and small vessel vasculitides (inflammation of small blood vessel walls) as a steroid sparing treatment.
In March, 2004 Myfortic, which is marketed by Novartis Pharma AG, was approved by the U.S. Federal Drug Administration (FDA) for the prophylaxis (prevention) of organ rejection in patients receiving allogenic (from one patient to another) renal transplants, administered in combination with corticosteroids and cyclosporine. Myfortic is available for oral administration in delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid.
But then on May 16, 2008, the FDA issued an alert warning that mycophenolic acid (MMA) increased the risk of a miscarriage in the first trimester and could cause serious congenital anomalies in the offspring of women who are treated during pregnancy. The alert also cited the drug CellCept, whose active ingredient, mycophenolate mofetil (MMF), is an ester (or salt version) of MMA.
The alert was in response to the FDA becoming aware of reports of infants born with serious congenital malformations after exposure to MMF during pregnancy. Both Myfortic and CellCept already had their Pregnancy Category changed in November, 2007 from a "C" to a "D", indicating positive evidence of human fetal risk. In the alert, the FDA recommends that women of childbearing potential who must take MMA or MMF should be aware of the risks to their fetus if they become pregnant, and practice abstinence or use adequate birth control.
Another danger of these drugs that was known prior to their approval is that due to drug-related adverse effects, 70 percent of patients taking MMF required at least one dose change. And in these clinical studies, patients who had their dose reduced were eight times likelier to suffer acute organ rejection than those who did not have a dose adjustment.
If you or someone you love had a miscarriage or gave birth to a child with congenital anomalies after being treated with Myfortic or CellCept, or if you were otherwise injured by exposure to these drugs, you may be entitled to compensation. A qualified pharmaceutical injury attorney can review your case and apprise you of your legal rights.