Decongestant Linked to Strokes

G A I T H E R S B U R G, Md., Oct. 20, 2000 -- 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

First Warnings in ’80s

Doctors’ first warning sign about PPA came in the 1980s whenmedical journals cited several dozen puzzling cases of young womenwho suddenly had strokes within days of taking appetitesuppressants.

The FDA’s own records show 44 cases of hemorrhagic stroke amongPPA users in the past 30 years. Most were women; the median age was35.

Those cases are “literally the very tip of the iceberg,” saidthe FDA’s Dr. Lois La Grenade, noting that the agency learns offewer than 10 percent of the serious side effects drugs cause eachyear.

Still, the industry successfully argued more research was neededto prove if PPA was to blame. So the Consumer Healthcare ProductsAssociation funded Yale’s five-year study comparing 702 hemorrhagicstroke survivors under 50 with 1,376 similar “controls” who hadnever suffered a stroke. The goal was to see if PPA use was morecommon among stroke sufferers than among healthy people.

Study: Risk for Women

The study found PPA increases stroke risk for young women — notmen — under two circumstances: within three days of takingPPA-containing appetite suppressants, or within three days oftaking their first-ever PPA dose for any reason.

Risk was highest with the higher doses — more than 75 milligramsdaily — that dieters were more likely to use. Also, first-time PPAuse sometimes temporarily raises blood pressure, an effect thatwanes as the body gets used to the drug.

The study did find few stroke patients who also took PPA, Kernansaid; his results were based on 13 dieters and first-time PPAusers.

But the results are statistically significant and suggest that,when taken by millions, PPA ultimately could be the cause of 200 to500 strokes a year in people under 50, La Grenade said.

The CHPA, which represents manufacturers of nonprescriptionmedicines and dietary supplements, now contends the Yale study isflawed. The group complains the numbers are too small to proveblame and that researchers excluded stroke victims who died or wereleft unable to speak — necessary because those people’s PPA usecouldn’t be determined. Also, the stroke patients were more likelyto smoke, drink and have other stroke risks than the control group.

But the FDA panel ruled the Yale study, when added to FDA’srecords and medical journal stroke reports, provides importantevidence linking PPA to strokes.