Health

Warning on Cough Medicines and Diet Drugs

By CBSNews.com staff CBSNews.com staff

January 31, 2002 / 8:40 AM EST / CBS

The Food and Drug Administration has issued a health warning against an ingredient found in many name-brand cold remedies and weight-loss drugs. The ingredient, phenylpropanolamine, or PPA, is reportedly unsafe. CBS Medical Correspondent Elizabeth Kaledin reports.

"We recommend consumers not use these products," says Charles Ganley, MD, of the Food and Drug Administration.

PPA is widely used as both an appetite suppressant and a nasal decongestant. Critics have questioned its safety for decades. Recent studies, however, confirmed a link between the drug and hemorraghic stroke (bleeding in the brain), particularly in women aged 18 to 49. Experts say the risk is small, but because the chemical is found in many products used by millions of Americans everyday, the FDA decided it was a risk too great to ignore. The agency has asked manufacturers to discontinue marketing products containing PPA.

Representatives of the over-the-counter drug market are not surprised about the FDA's action, since PPA has been under scrutiny for a long time.

"It's safe to say that companies have been moving away from PPA use as a primary active ingredient for nasal decongestants," says Mara Goldstein of the CIBC World Markets.

Manufacturers plan to comply with the FDA, but they don't concede that the drug is harmful.

"Even as our members are standing by the safety of their products, they acknowledge FDA's action and decision to move forward with new regulations," says William Soller of the Consumer Healthcare Products Association.

Some companies are expected to recall their products, while others may reformulate them. Makers of the diet drug, Dexatrim, recently developed "Dexatrim Natural."

The FDA based its decision on PPA on a Yale University School of Medicine study in which researchers found an association between phenylpropanolamine use and stroke in women. Investigators found an increased risk of hemorrhagic stroke in women using the drug for weight control and for nasal decongestion within 3 days after use of the medication. Men may also reportedly be at risk.