The FDA is warning doctors and patients that CellCept, a drug for organ transplant patients, can cause miscarriages and birth defects. Made by Roche, CellCept will get a "black box" warning that it's been linked to first-trimester pregnancy loss and ear and mouth defects in infants.
Roche cited 25 miscarriages among 77 women exposed to the drug during pregnancy between 1995 and 2007; 14 of the women had babies with birth defects. However, to put this in perspective, more than 450,000 men and women have taken the drug since its 1995 approval.
- read the Houston Chronicle article for more
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