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Pregnancy Category CThere are no adequate and well-controlled trials with VENTOLIN HFA or albuterol sulfate in pregnant womenDuring worldwide marketing experiencevarious congenital anomaliesincluding cleft palate and limb defectshave been reported in the offspring of patients being treated with albuterolSome of the mothers were taking multiple medications during their pregnanciesNo consistent pattern of defects can be discernedand a relationship between albuterol use and congenital anomalies has not been establishedAnimal reproduction studies in mice and rabbits revealed evidence of teratogenicityVENTOLIN HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetusWomen should be advised to contact their physicians if they become pregnant while taking VENTOLIN HFA.

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