Sunday, October 22, 2000

Drug risk study has Tristate link

By Tim Bonfield
The Cincinnati Enquirer

        The risk may be as low as 1 in 9 million, but a new study reports that some people who chew Acutrim appetite suppressant gum or take Contac, Dimetapp, Comtrex or Alka-Selzter cold medications can die from brain hemorrhages.

        The Food and Drug Administration is considering whether to ban or restrict the use of a compound called phenylpropanolamine (PPA). This compound is found in 22 well-known appetite suppressants and cold medications.

    There are 22 medicines on the market that contain phenylpropanolamine, according to the Consumer Healthcare Products Association, a trade group.
    • AcuTrim Diet Gum Appetite Suppressant.
    • AcuTrim Maximum Strength.
    • Alka-Seltzer Plus Cold Medicine.
    • Alka-Seltzer Plus Children's.
    • BC Allergy Sinus Cold Powder.
    • BC Sinus Cold Powder.
    • Comtrex Flu Therapy & Fever Relief.
    • Contac 12-hour Cold Capsules.
    • Contac 12-hour Cold Caplets.
    • Coricidin "D' Cold, Flu and Sinus.
    • Dexatrim Gelcaps.
    • Dimetapp Cold and Allergy Chewable Tablets.
    • Dimetapp LiquiGels.
    • Dimetapp DM Cold and Cough Elixir.
    • Naldecon DX Pediatric Drops.
    • Permathene Mega-16.
    • Robitussin Allergy Cough.
    • Robitussin CF.
    • Tavist-D 12-hour Relief.
    • Triaminic DM Cough Relief.
    • Triaminic Expectorant.
    • Triaminic Syrup.
   Source: USA Today

        That action is based on findings from a recently completed five-year study led by Yale University, in which more than 200 residents of the Tristate took part. They were among 720 stroke victims studied.

        Hundreds of lives and billions of dollars are at stake in this debate. Last week, an FDA advisory committee concluded that PPA was not safe as an over-the-counter drug because it increases the risk of stroke from bleeding in the brain. But whether medications containing PPA will be pulled off the market, reformulated or subjected to new warning labels remains to be seen.

        On Friday, the Enquirer interviewed Dr. Joseph Broderick, director of the Greater Cincinnati-Northern Kentucky Stroke Team, who has been involved in this issue since the early 1990s and attended the FDA committee hearing. QUESTION: How did concerns about PPA begin?

        ANSWER: Most strokes occur from blockages in arteries. But some occur because arteries burst, allowing bleeding into the brain. Hemorrhagic strokes account for about 15 percent of all strokes. We have been studying why hemorrhagic strokes occur. There have been case reports going back 20 years of people taking PPA shortly before suffering a stroke. Back in 1991 or 1992, we were approached by Yale after they got a request from the FDA to do a study. The concern was mostly about women taking appetite suppressants.

        Q: How many people were studied?

        A: The study included about 720 people recruited mostly from Yale and from us. Later, Brown University and the University of Texas were added. We enrolled about 225 people from 17 local hospitals.

        Q: What did the study find?

        A: The study found an association between PPA and stroke, especially for people taking appetite suppressants. Overall, PPA increased the risk of stroke by two or three times. But for appetite suppressants (which involve a higher dose of PPA) the increased risk was 16-fold.

        Q: But isn't that an increase from a very low risk to begin with?

        A: That's right. The FDA used an estimate of about 10,000 people a year under the age of 50 who suffer a hemorrhagic stroke. Out of those, 2 to 5 percent, or 200 to 500 cases, may be associ ated with PPA use.

        Q: How often are these cold medications and appetite suppressants used?

        A: The estimate is about 4.5 billion doses a year. So you can see that the risk would be very low (about 1 in 9 million per dose, assuming 500 cases).

        Q: How serious is a hemorrhagic stroke?

        A: There aren't very good treatments. The mortality rate is 40 to 50 percent. Most of those who survive are severely disabled. So we're talking about a very serious event resulting from an over-the-counter medication. There are many prescription drugs with far higher risks of serious side effects. But most people would probably expect the risk of a fatal side effect from taking a cold pill should be as near zero as possible.

        Q: Do you think the FDA should ban PPA?

        A: That's not my decision.

        Q: What would you tell a patient or a friend about using PPA?

        A: I would tell my friends with regards to diet aids, they would be better off not taking them. For one thing, the benefits of the diet aids don't seem to last. So the risk isn't worth taking — especially if you smoke or have high blood pressure (which also increase stroke risk)

        Q: What about the cold medications?

        A: That's a more complicated issue. There does appear to be a relationship between dose and effect, and the PPA dose in cold medications is lower than in the appetite suppressants. I wouldn't recommend them for anyone who smokes or has high blood pressure. There are other kinds of decongestants out there that don't have PPA.

        Q: Such as?

        A: Well, Sudafed would be one.

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