FDA Warns Against PPA in Cold Remedies

W A S H I N G T O N, Nov. 6, 2000 -- The Food and Drug Administration warnedAmericans today not to use dozens of over-the-counter coldremedies or appetite suppressants until their makers replace aningredient that may cause hemorrhagic strokes, especially in youngwomen.

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

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

The risk of a hemorrhagic stroke, or bleeding in the brain, isvery small to an individual user. But with millions of Americansswallowing PPA every day, the FDA determined the ingredient couldbe 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.

FDA Says Use Alternatives

“We suggest you stop taking the drug immediately and use analternative,” says an FDA warning issued for consumers today.

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

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

Drug manufacturers had fought the FDA’s decisions, arguing thatconcern over the decades-old ingredient was overblown. But in apublic hearing less than three weeks ago, FDA’s scientific advisersdealt manufacturers a blow by voting unanimously that PPA isunsafe.

Hemorrhagic strokes, while the least common type of stroke,often are deadly and can leave survivors disabled. They are veryrare in people under age 50; the risk rises with age, as well aswith high blood pressure, smoking, alcohol and use ofblood-thinning medicines.

First Warning in the ’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.

But the drug industry successfully argued more research wasneeded to prove if PPA was to blame. So the Consumer HealthcareProducts Association funded a five-year study by Yale Universitycomparing 702 hemorrhagic stroke survivors under 50 with 1,376similar “controls” who had never suffered a stroke. The goal wasto see if PPA use was more common among stroke sufferers than amonghealthy people.

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.

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

But the FDA ultimately concluded there was no way to predict whowas most at risk from using PPA. While the ingredient does clear astuffy nose, that’s just not a big enough benefit to take thechance, 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 irreversibleevent.”