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Diet ingredient linked to strokes

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October 21, 2000 

GAITHERSBURG, Md. (AP) -- An ingredient in dozens of popular over-the-counter diet and cold medicines may be the cause of several hundred hemorrhagic strokes suffered annually by people under 50, government scientists said Thursday.

Manufacturers insist concern over the decades-old ingredient -- called phenylpropanolamine and found in products ranging from Dexatrim to Triaminic -- is overblown. They argue there is no proof the drug causes hemorrhagic strokes, or bleeding in the brain.

But the Food and Drug Administration's scientific advisers voted Thursday that phenylpropanolamine cannot be classified as safe, a classification critical to drugs' ability to sell without a prescription.

The FDA already was considering banning nonprescription phenylpropanolamine, or PPA. The advisory panel's 13-0 vote, with one abstention -- while not directly addressing the question of a ban -- strengthens that possibility. The FDA is not bound by its advisers' decisions but usually follows them.

The risk for the average dieter or cold sufferer in using PPA is very small, say the FDA and Yale University researchers who studied the 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 associated with an increased risk of hemorrhagic stroke but it is not a huge risk,'' Yale medical professor Dr. Walter Kernan said.

But some FDA advisers said consumers should know they can choose over-the-counter decongestants without PPA, and that dieters do best when working with a doctor.

Hemorrhagic strokes, while the least common type of stroke, often are deadly and can leave survivors disabled. They are very rare in young people: The FDA estimates that of the 130 million Americans ages 18-49, 10,400 suffer a hemorrhagic stroke each year. The risk rises with age; other risk factors include high blood pressure, smoking, alcohol and use of blood-thinning medicines.

Doctors' first warning sign about PPA came in the 1980s when medical journals cited several dozen puzzling cases of young women who suddenly had strokes within days of taking appetite suppressants.

The FDA's own records show 44 cases of hemorrhagic stroke among PPA users in the past 30 years. Most were women; the median age was 35.

Those cases are "literally the very tip of the iceberg,'' said the FDA's Dr. Lois La Grenade, noting that the agency learns of fewer than 10 percent of the serious side effects drugs cause each year.

Still, the industry successfully argued more research was needed to prove if PPA was to blame. So the Consumer Healthcare Products Association funded Yale's five-year study comparing 702 hemorrhagic stroke survivors under 50 with 1,376 similar "controls'' who had never suffered a stroke. The goal was to see if PPA use was more common among stroke sufferers than among healthy people.

The study found PPA increases stroke risk for young women -- not men -- under two circumstances: within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason.

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

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

But the results are statistically significant and suggest that, when taken by millions, PPA ultimately could be the cause of 200 to 500 strokes a year in people under 50, La Grenade said.

The CHPA, which represents manufacturers of nonprescription medicines and dietary supplements, now contends the Yale study is flawed. The group complains the numbers are too small to prove blame and that researchers excluded stroke victims who died or were left unable to speak -- necessary because those people's PPA use couldn't be determined. Also, the stroke patients were more likely to smoke, drink and have other stroke risks than the control group.

But the FDA panel ruled the Yale study, when added to FDA's records and medical journal stroke reports, provides important evidence linking PPA to strokes.