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On November 22, 2006, the FDA approved safety labeling revisions for valsartan tablets ( Diovan, made by Novartis Pharmaceuticals Corp) to advise of the risk for fetal/neonatal morbidity and mortality associated with its use.
No recall announcements could be found.
There is a Black Box warning on Diovan concerning the risks associated with pregnancy.
Not for Use When Pregnant
Diovan should not be taken by pregnant women or along with pregnancy-related drugs that act directly on the renin-angiotensin system because this may cause fetal or neonatal morbidity, and in some cases mortality. If you become pregnant while taking Diovan, stop taking the medication immediately and call a doctor.
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Posted by neail