Revised Azilect Labeling Allows Use With OTC Cough, Cold Drugs

The FDA has approved revised labeling for Teva Pharmaceutical Industries’ Parkinson’s disease drug Azilect. The new prescribing information reflects less concern about the use of Azilect (rasagiline mesylate) with certain medications, including many OTC cold products and weight-reducing preparations that contain vasoconstrictors, such as pseudoephedrine, phenylephrine, phenylpropanolamine and ephedrine. The labeling change is based on the results of a study Teva submitted to the FDA that showed the drug does not interfere with patients’ ability to eliminate tyramine, which can induce hypertension.
Washington Drug Letter