A high-ranking official from the US Food and Drug Administration (FDA) told a Congressional committee on Wednesday that the agency believes it has taken adequate steps to address the severe psychiatric events that have been reported in patients taking Roche’s acne drug Accutane (isotretinoin).
“FDA has worked diligently with the manufacturer and the medical and scientific communities to assure that patients have access to Accutane under conditions that make its use as safe as possible,” said Dr. Janet Woodcock, who heads up the agency’s Center for Drug Evaluation and Research.
Woodcock’s remarks followed an appeal by family members of past patients, who told the federal lawmakers it is imperative that the FDA take further action.
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