Decongestant Linked to Strokes
G A I T H E R S B U R G, Md., Oct. 20 -- An ingredient in dozens of popularover-the-counter diet and cold medicines may be the cause ofseveral hundred hemorrhagic strokes suffered annually by peopleunder 50, government scientists said Thursday.
Manufacturers insist concern over the decades-old ingredient — called phenylpropanolamine and found in products ranging fromDexatrim to Triaminic — is overblown. They argue there is no proofthe drug causes hemorrhagic strokes, or bleeding in the brain.
But the Food and Drug Administration’s scientific advisers votedThursday that phenylpropanolamine cannot be classified as safe, aclassification critical to drugs’ ability to sell without aprescription.
The FDA already was considering banning nonprescriptionphenylpropanolamine, or PPA. The advisory panel’s 13-0 vote, withone abstention — while not directly addressing the question of aban — strengthens that possibility. The FDA is not bound by itsadvisers’ decisions but usually follows them.
‘Not a Huge Risk’
The risk for the average dieter or cold sufferer in using PPA isvery small, say the FDA and Yale University researchers who studiedthe issue. Six billion PPA doses are sold in this country annually,yet hemorrhagic strokes in young people are rare.
“The message for women should be, PPA does appear associatedwith an increased risk of hemorrhagic stroke but it is not a hugerisk,” Yale medical professor Dr. Walter Kernan said.
But some FDA advisers said consumers should know they can chooseover-the-counter decongestants without PPA, and that dieters dobest when working with a doctor.
Hemorrhagic strokes, while the least common type of stroke,often are deadly and can leave survivors disabled. They are veryrare in young people: The FDA estimates that of the 130 millionAmericans ages 18-49, 10,400 suffer a hemorrhagic stroke each year.The risk rises with age; other risk factors include high bloodpressure, smoking, alcohol and use of blood-thinning medicines
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