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Ingredient in Popular Cold Medicines May Increase Risk of Stroke

Aired October 20, 2000 - 2:50 p.m. ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

NATALIE ALLEN, CNN ANCHOR: Some unsettling news, now about common medications for the common cold: There is evidence they can sometimes cause increased risk of stroke.

We get the story from CNN's Jonathan Aiken.

(BEGIN VIDEOTAPE)

JONATHAN AIKEN, CNN CORRESPONDENT (voice-over): At issue is the safety of some of the most popular over-the-counter cold and diet medicines, all containing a drug known as phenylpropanolamine, or PPA for short.

PPA is good at relieving nasal congestion. It's also a popular as a diet pill because it suppresses the appetite. The FDA Advisory Committee accepted the findings of a five-year study by Yale University researchers suggesting PPA could increase the risk of stroke in men and women between the ages of 18 and 49.

DR. RAYMOND WOOSLEY, GEORGETOWN UNIVERSITY: I think most people believe that a short course of a decongestant is probably OK. I think the concern is, when people take these for more prolonged periods of time, they have more sustained increases in blood pressure that put them at that greater risk.

AIKEN: The Yale study doesn't sit well with the consumer health care products association, the trade group for over-the-counter medicines. The group not only commissioned the study, but also helped design and pay for it.

After receiving the critical report, the association commissioned a separate study by independent epidemiologists, who unanimously said the Yale study was flawed science; in particular, the choice of study subjects, some of whom had other risks of stroke.

Despite industry skepticism of the Yale study, the FDA's own analysis confirmed its findings and concluded between 200 and 500 hemorrhagic strokes per year could be linked to PPA and that the risk grows when PPA doses exceed 75 milligrams a day.

DR. CHARLES HENNEKENS, CONSULTANT: My colleagues and I were quite surprised that the FDA has taken such an extreme position with regard, not only to the interpretation of the study, but the implications for recommendations for public health.

AIKEN: PPA has been on the market for 50 years, but over the past two decades, several case studies have linked the drug to bleeding on the brain.

DR. SIDNEY WOLFE, PUBLIC CITIZEN: If you were considering today the switching of phenylpropanolamine from prescription-only to over- the-counter, I think the answer would clearly be no.

AIKEN (on camera): The industry insists that PPA is safe as a cold or flu remedy, even as a diet pill as long as it's used as directed. The Food and Drug Administration now has up to 90 days to decide whether or not to accept it's advisory committee's recommendation.

Jonathan Aiken for CNN, Washington.

(END VIDEOTAPE)

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