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FDA Warns of Over-the-Counter Drug

Mar 5, 2004 | AP

The Food and Drug Administration warned Americans Monday not to use dozens of over-the-counter cold remedies or appetite suppressants until their makers replace an ingredient that could cause hemorrhagic strokes, especially in young women.

The ingredient, called phenylpropanolamine or PPA, is found in products ranging from Dexatrim to Triaminic.

The FDA said it is taking steps to formally ban PPA, but in the meantime wrote manufacturers asking them voluntarily to immediately quit selling products containing the ingredient.

The risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user. But with millions of Americans swallowing PPA every day, the FDA determined the ingredient could be to blame for 200 to 500 strokes just in people under age 50 - those who typically are too young to be at risk for strokes.

``We suggest you stop taking the drug immediately and use an alternative,'' says an FDA warning issued for consumers Monday.

Consumers should check the ingredient list of all nonprescription cold relievers for PPA and avoid those products, the FDA said. Instead, they could use cold pills containing the ingredient pseudoephedrine, or use nasal sprays.

However, PPA is the only nonprescription diet ingredient on the market. There are prescription weight-loss drugs, so dieters should consult their physicians about their options, said FDA nonprescription drugs chief Dr. Charles Ganley.

Drug manufacturers had fought the FDA's decisions, arguing that concern over the decades-old ingredient was overblown. But in a public hearing less than three weeks ago, FDA's scientific advisers dealt manufacturers a blow by voting unanimously that PPA is unsafe.

Hemorrhagic strokes, while the least common type of stroke, often are deadly and can leave survivors disabled. They are very rare in people under age 50; the risk rises with age, as well as with 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.

But the drug industry successfully argued more research was needed to prove if PPA was to blame. So the Consumer Healthcare Products Association funded a five-year study by Yale University 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.

Nobody knows why PPA would have that effect, although first-time PPA use sometimes temporarily raises blood pressure, an effect that wanes as the body gets used to the drug. Risk was highest with the higher doses more than 75 milligrams daily that dieters were more likely to use.

But the FDA ultimately concluded there was no way to predict who was most at risk from using PPA. While the ingredient does clear a stuffy nose, that's just not a big enough benefit to take the chance, the FDA ultimately decided.

``Not to be alarmist it's clear this is a very rare event,'' Ganley said. ``But even though it's rare, it's an irreversible event.''