New Warnings for Anti-Rejection Drug

The U.S. Food and Drug Administration revised the pregnancy category for mycophenolic acid (Myfortic) from category C to category D. A new, boxed warning has also been added to this immunosuppressant drug, which is used for combating rejection of solid organ transplants.

The change was prompted by reports of increased risk of pregnancy loss and congenital malformations in two different groups of women. The warnings caution women about the risk of specific congenital malformations that occur during the first trimester, especially involving the external ear, distal limbs, heart, esophagus, and kidneys. There is also a greater incidence of cleft lip and cleft palate deformities.

Two sets of data analysis supported the need for a pregnancy category change. In one set, 24 female transplant patients reported 33 pregnancies while taking anti-rejection drug regimens. These women experienced 15 spontaneous abortions and 18 live births, of which four (22%) had structural malformations. In the second set, 77 women experienced 25 spontaneous abortions, and 14 had a malformed infant or fetus.

Patient teaching: Stress the appropriate use of effective contraception during therapy with Myfortic. Before therapy can begin, women must have a negative pregnancy test. From that point forward, women must use two reliable methods of birth control at the same time. Women who desire to become pregnant must discuss their plans with their prescribing professional, and alternative methods of managing transplant rejection risk should be attempted.

Caution: Review current drug information before administering and monitoring medications.


source: nurse.com