US FDA Cttees View epinephrine, Ephedrine

The US Food and Drug Administration's advisory committees on nonprescription drugs and pulmonary-allergy drugs have said that epinephrine should remain available OTC and that an appropriate population exists for current OTC asthma therapies.

However, members of the pulmonary-allergy committee expressed concern at the meeting that an appropriate population for OTC asthma treatments has not been clearly identified, and also at the lack of effectiveness and safety data relating to these products. it was suggested that these products should carry more informative and useful labeling.

The meeting also heard considerable opposition from government, industry and consumer groups to proposed switching of prescription beta agonist products such as albuterol and cromolyn sodium to OTC status. Worries expressed about such switches including the lack of physician care, education and proper diagnosis, the treatment of symptoms rather than the underlying cause, inappropriate use, and the potential for increased out-of-pocket expenses, reports the Nonprescription drug manufacturers Association.