The warnings will advise consumers not to take a PPA-containing drug with any other product that contains PPA, phenylephrine, pseudoephedrine or ephedrine. Some data indicate that PPA, in OTC drugs, may increase the risk of hemorrhagic stroke. FDA awaits these data from an industry-sponsored PPA safety study. In the interim, the agency believes that it should require enhanced, directive warnings on how consumers can safely use these products.
Hemorrhagic strokes differ from ischemic strokes in that they result from bleeding into the brain.
Ischemic strokes result from a blood vessel blockage that impairs the blood flow to the brain. PPA affects the central nervous system and the cardiovascular system and should not be taken with other products that contain PPA, phenylephrine, pseudoephedrine or ephedrine, which have similar effects on the body. In addition, persons with high blood pressure, heart or thyroid disease, or diabetes should not use PPA without consulting a doctor.