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FDA debates status of decongestant drugs

by Medindia Content Team on Feb 8 2002 2:14 PM

An advisory committee for the Food and Drug Administration agreed that an ingredient commonly used in over-the-counter decongestants is unsafe, and it plans to recommend further review by the FDA.

The FDA Non-Prescription Drugs Advisory Committee met to discuss a new five-year study by Yale University researchers that found phenyl-propanolamine (PPA), an active ingredient in non-prescription drugs, can increase the risk of stroke in some users. PPA helps constrict blood vessels, thus relieving nasal congestion, and has been shown to aid in weight loss. The compound is in hundreds of over-the-counter cold, cough and allergy medicines and appetite suppressants.

And while products containing such ingredients are required to list such warnings on their labels, the warnings often go unnoticed or ignored by many who assume over-the-counter drugs are safe for one and all. One big reason such warnings may be ignored is because nearly half of the estimated 50 million people in the United States with high blood pressure don't even realize they have a problem.

The problem is that the active ingredients in many decongestants can't target the blood vessels in the nose. Instead, they constrict blood vessels throughout your body, and raise your blood pressure. If you already have high blood pressure, that can increase your risk for stroke or heart attack.

Furthermore, the decongestants can work against anti-hypertensive drugs that patients might take for their high blood pressure. There are over-the-counter cold and flu products that claim to be safe for people with high blood pressure, but they're unlikely to help those looking for a decongestant.


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