FDA warns of fetal risk with transplant drugs

U.S. health officials issued an alert on Friday about the risks of miscarriages and birth defects from Novartis AG and Roche Holding AG transplant drugs.

A strong warning about those risks was added to the labels of Roche’s CellCept and Novartis’ Myfortic in November. The new alert was meant, in part, to grab the attention of doctors who prescribe the drugs for unapproved uses such as treating lupus, Food and Drug Administration spokesman Christopher Kelly said.

The FDA alert also was issued as a reminder to doctors who prescribe the drugs for the approved use of preventing rejection of transplanted organs, Kelly said.

Roche spokesman Christopher Vancheri said the company had sent a letter to doctors about the risk when the warning was added last year.

The FDA’s Kelly said some doctors who prescribe the drugs for unapproved use may not have noticed the labeling change or the letter from manufacturers.

Officials at Novartis could not immediately be reached for comment.