FDA Warns Against PPA in Cold Remedies

W A S H I N G T O N, Nov. 6 -- 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.