Not too worried about a drug that causes club feet
There were six pregnancies in the placebo-controlled clinical trials. The label states that, of the six women who became pregnant in clinical trials, four delivered healthy babies when, in fact, one of the “healthy babies” had bilateral club feet. Two outcomes were unknown as one patient was lost to follow-up and one pregnancy was electively terminated. Following the completion of the clinical trials, eight more pregnancies have been reported to the FDA (through September 2008), one with an unspecified congenital anomaly.
There were six pregnancies in the placebo-controlled clinical trials. The label states that, of the six women who became pregnant in clinical trials, four delivered healthy babies when, in fact, one of the “healthy babies” had bilateral club feet. Two outcomes were unknown as one patient was lost to follow-up and one pregnancy was electively terminated. Following the completion of the clinical trials, eight more pregnancies have been reported to the FDA (through September 2008), one with an unspecified congenital anomaly.
Amitiza
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