The FDA has announced that two immunosuppressant drugs, CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), can cause birth defects and miscarriages. Immunosuppressant drugs are used to prevent rejection after organ transplants and to treat autoimmune diseases such as lupus and rheumatoid arthritis.
The alert was first issued by the FDA in October, 2007, and was reposted May 16, 2008 because the FDA worried that doctors may not have seen the original warning.
There have been reports of high rates of miscarriage and birth defectsassociated with taking CellCept. While neither adverse effect has been directly linked to Myfortic use, the warning includes the drug because it is chemically similar to CellCept and is likely to pose the same risks.
Purpose of immunosuppressants
Most often these drugs are used to prevent rejection after organ transplants. An organ transplant can trigger an immune system response because the body recognizes the new organ as a foreign object.
Immunosuppressants are also prescribed to treat autoimmune disease, although they are not approved for this purpose. In autoimmune diseases the immune system malfunctions and your body actually attacks itself.
Adverse effects
Adverse effects linked to the drugs include spontaneous abortion and structural defects. Adverse effects can include:
- Miscarriage
- Cleft lip
- Cleft palate
- Ear malformation
The FDA’s concerns are based on data from the National Transplantation Pregnancy Registry and post marketing data collected by Roche (maker of CellCept). The National Transplantation Pregnancy Registry reports that in 33 pregnancies there were 15 miscarriages and of the 18 surviving babies four had birth defects. Roche reports that of 77 pregnant women, who were taking the drug, 25 had miscarriages and 14 had a malformed infant or fetus.
Minimizing the risk
Doctors know not to prescribe these drugs to women who are pregnant or who are planning to become pregnant. The problems occur most often when women begin taking the drugs before they become pregnant and continue taking them while they are pregnant but before the pregnancy is discovered.
To minimize this risk, doctors are advised to test patients for pregnancy before they begin taking the drug. They are also to instruct their patients to use two forms of contraception while taking the medication and for four weeks before and six weeks after their treatment. Both CellCept and Myfortic may reduce the efficacy of oral contraceptives.
If you believe that your child was harmed by either of these medications, you should contact an experienced pharmaceutical injury attorney in your areato evaluate your claim.
