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 [1] for more
Related Articles:
Aspreva, Roche put CellCept on ice. Report [2]
Aspreva's CellCept fails late-stage superiority study. Report [3]
Aspreva Pharmaceuticals drug fails Phase III trial. Report [4]
CellCept wins orphan status. Report [5]
Links:
[1] http://www.chron.com/disp/story.mpl/ap/fn/5255541.html
[2] http://www.fiercebiotech.com/story/aspreva-roche-put-cellcept-ice/2007-09-10
[3] http://www.fiercebiotech.com/story/aspreva-s-cellcept-fails-late-stage-superiority-study/2007-06-27?utm_source=related&utm_medium=internal
[4] http://www.fiercebiotech.com/story/aspreva-pharmaceuticals-drug-fails-phase-iii-trial/2006-10-27
[5] http://www.fiercebiotech.com/story/spotlight-cellcept-wins-orphan-status/2006-01-04