The U.S. Food and Drug Administration has scolded Bausch Health for a video and webpage that made misleading claims about a plaque psoriasis treatment, the second time this year the agency has tagged a big drugmaker for overlooking the risks and benefits of a medicine in promotional materials.
In a March 22 letter, the FDA wrote that a Bausch video failed to say that its Duobrii topical cream can cause birth defects. The video, which had been visible on YouTube but has since been taken down, failed to note that women should get a pregnancy test before applying the cream and should use contraception. The video, which can still be seen here, also lacked warnings about photosensitivity and the risk of sunburn.
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