An advisory panel is recommending that the FDA ban the drug phenylpropanolamine, or PPA, found in dozens of popular over-the counter cold medications and diet drugs used by millions of Americans.
PPA, found in cough and cold remedies and weight loss drugs, has been linked to an elevated stroke risk.
Julie A. Johnson, Pharm.D., is on the Food and Drug Administration's Nonprescription Drugs Advisory Committee, the panel that made the recommendation. Johnson spoke with The Early Show about the decision.
PPA has two uses, Johnson says. First, it is used as a decongestant, to relieve stuffiness in your nose. Second, it acts as an appetite suppressant.
It's an ingredient in about 50 different over-the-counter cold medicines and diet products, she says. Look for it listed in the products' ingredients as "phenylpropanolamine." PPA has been on the market for a very long time. It was already on the market when the stricter FDA drug rules came out, so it never received the same scrutiny that a drug seeking to be approved today would receive.
Strokes Raised FDA Suspicions
Johnson says the safety of PPA influenced the panel's decision. There had been reports over the past 20 years associating PPA with the risk of hemorrhagic stroke.
Over the years, the FDA received a number of voluntary complaints that young persons between the ages of 18 and 49 were having these brain hemorrhages within a few days of taking a product containing PPA. The results of these hemorrhagic strokes ranged from death to severe permanent disability to varied residual effects. A disproportionate number of the stroke victims were women, since more women tend to use products containing PPA.
These complaints made the FDA suspicious, so the Consumer Health Products Association (CHPA), which represents nonprescription drug making companies, commissioned a study to look at the possible link between PPA and strokes.
The study, led by researchers at Yale University, spent five years looking at over 700 stroke patients. It found that the chances of having a stroke greatly increased if a person took PPA.
A stroke in a young person is a very uncommon event, but the study found that the risk of stroke increases for young women within 3 days of taking appetite suppressants containing PPA or within three days of taking their first-ever dose of PPA, such as in a cold medicine, Johnson says. The risk was highest with the higher PPA doses (more than 75 milligrams daily) that dieters were more likely to use.
The committee's vote means that the group believes the data that PPA raises the risk of stroke, Johnson explains. Of 14 voting members of the advisory committee, 12 voted that that PPA as "unsafe," and two abstained. No one voted that PPA was safe. So by labeling a product like PPA as "unsafe," the committee makes it clear that they believe that the risks outweigh the benefits and that PPA-containing products should not be on the market and available to the public. ©MMII CBS Worldwide Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed
Now, the FDA must decide for itself what is an acceptable level of risk--they need to decide whether to pull the product off the shelves or just require a warning.
It doesn't mean that consumers won't be able to buy cold medications, however. There are a number of other decongestant drugs available that can easily replace PPA without the risk, Johnson says, and the popular cold remedy products containing PPA will probably remain on the market, but the manufacturers will have to replace the PPA ingredient in them.
The diet drugs are another story, Johnson says. Phenylpropanolamine is the active or main ingredient in over-the-counter diet suppressants and currently there is nothing on the market tat can replace it.
Johnson says she personally would recommend not taking drugs containing PPA because she feels the risks outweigh the benefits. Since there are cold remedy products out there without PPA, people should read the labels carefully and buy PPA-free products, she says.
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