The US Food and Drug Administration issued a warning this week for Americans to stop using over-the-counter cold remedies and diets pills containing phenylpropanolamine, or PPA, because it could cause hemorrhagic strokes--bleeding in the brain, especially in young women. The decision was based largely on a Yale University study being released in the New England Journal of Medicine. Dr. Bernadine Healy talks to us about the study, the effects of PPA, products involved and alternative drugs to PPA and their effectiveness.
- What is phenylpropanolamine?
- If PPA has been on the market for the last 50 years, how did the FDA come to decide the ingredient is now no longer safe to use?
- Do we know if PPA has the same effect on women in other age groups or in men?
- Do all cold remedies contain PPA?
It's an active ingredient found in some over-the-counter cold remedies and appetite suppressants. It is similar in structure to amphetamine and has been on the market for 50 years.
The FDA based its decision on a five-year study of men and women by scientists at Yale University. They reported that PPA was associated with a small, but significant increase in the risk of stroke among young women. The study found that women aged between 18 to 49 who took phenylpropanolamine as an appetite suppressant were as much as 15 times more likely than other women to suffer hemorrhagic stroke. Also, first-time users of PPA were three times as likely to suffer a stroke, although we don't know why PPA sometimes temporarily raises blood pressure which is an effect that wanes as the body gets used to the drug.
This Yale study didn't find men at risk, but the FDA cautions that enough men weren't studied to be sure they're okay. While the risk of a hemorrhagic stroke is very small to an individual user, these are often deadly strokes and survivors can be left disabled. Hemorrhagic strokes usually occur in the elderly and are extremely rare under age 50. However, The FDA estimates that PPA could be to blame for 200 to 500 strokes a year just in people under age 50.
No, but dozens of cold remedies that contain decongestants do. And, although drug manufacturers and many drug store chains have pulled the products from the shelves, they could still be in your medicine cabinet. So it's important to check for propanolamine or PPA in the ingredient list. If you have medications that contain PPA, throw them out.
We've got a list of brands that may contain PPA. For cold remedies, there are many formulas of each brand name and not every formula contains PPA so it's important to check the ingredient list.
- Alka-Seltzer Plus
- Contac 12
- Coricidin "D"
Besides these brnd names, it's also important to check many generic and store brands that may also contain PPA.
- Nasal sprays
Many cold remedies use the safe alternative pseudoephedrine, so look for that name in the ingredient list instead of PPA.
You might also want to try nasal sprays as another alternative.
However, for appetite suppressants, PPA is the only approved non-prescription weight-loss drug. So, right now, over-the-counter alternatives do not exist. Dieters should consult their doctor about prescription-only alternatives.
Ephedra is a popular herbal weight-loss treatment, sold under a variety of names including Ma Huang, Chinese Ephedra and epitonin. It is classified as dieary supplements and therefore escape regulation by the FDA, but a published article this week found ephedra appears to pose a real risk of heart attack and other serious and even deadly complications in people who use it. Researchers evaluated 140 reports of illness or death linked to ephedra alkaloids. The compounds are stimulants derived from shrubs that are similar to ephedrine found in over-the-counter cold remedies. Of the 140 patients, 10 died and 13% were permanently disabled.
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