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medpundit |
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Saturday, March 01, 2003The Food and Drug Administration stressed that the expectorant, extended-release guaifenesin, is not dangerous. Instead, the crackdown comes as part of the FDA's efforts to re-examine very old drugs that began selling before the government ever required proof that drugs worked well. In the case of this prescription cough ingredient, one company went back and found that proof. Last July the FDA formally approved sale of Adams Laboratories' Mucinex. Under FDA regulations, competing companies' unapproved versions then were automatically deemed illegal. Guaifenesin is the active ingredient in such old stand-bys as Robitussin. It’s been around for a long time, with no reports of serious adverse events. Yet, drugs like ephedra, which have been linked to deaths, can be sold freely with only a warning label (and that with some effort). Crazy world. posted by Sydney on 3/01/2003 08:44:00 AM 0 comments 0 Comments: |
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