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Are You Concerned About Recent Reports Linking Cold Medications And Stroke?

Recent news reported that the Food and Drug Administration (FDA) required that phenylpropanolamine (PPA), a common ingredient in diet pills and many cold preparations, be taken off the over-the-counter (OTC) roster and limited to prescription-only use due to its association with a significantly increased risk of hemorrhagic strokes in women (but not men) under 50 per year.

While there is no direct proof that PPA is the direct cause of the strokes that occurred, the Advisory Committee strongly recommended that the FDA limit PPA use to prescription only since it can no longer definitively be considered "safe".  This product was contained in numerous cold products (e.g. Triaminic and numerous generic brands) as well as over-the-counter diet pills (e.g. Dexatrim).  OTC diet pills are much more commonly used by women than men, which may explain the disproportionate increase in hemorrhagic strokes seen after PPA use in women versus men.  The dosage of PPA used was also positively correlated to incidence of hemorrhagic stroke; having smaller body mass may increase the dose effect in women compared to men as well.

While the FDA is not bound by Advisory Committee recommendations, it  usually follows them. The other option the FDA is considering, which was not addressed by the Advisory Committee, is banning PPA altogether. 

While the risk for the average dieter or cold sufferer using products containing PPA is very small, some say no additional risk is warranted when there are equivalent cold preparations available with alternate choices of decongestants (e.g. pseudoephedrine, the active ingredient is Sudafed.   Dieters seeking medications to assist them with weight loss should consult their physicians.

The manufacturers of most popular brands of cold medications which contained PPA have already reformulated them to use other ingredients, and all pharmacies have removed products containing PPA from their shelves. What consumers need to be aware of are the products in their medicine cabinets which they purchased before the ban, which was in late winter 2000. If you have products containing PPA, they should be discarded, even if they have not yet reached their expiration date.

Hemorrhagic strokes involve bleeding into the brain.  They are very rare in adults under 50. The FDA estimates that in the 130 million Americans between 18-49, 10,400 hemorrhagic strokes occur each year. While they are the least common type of stroke, they are more likely to be fatal or to completely disable survivors.

The risk of hemorrhagic stoke rises with age.  Other risk factors include high blood pressure; smoking; alcohol consumption; and use of blood-thinning medicines.  People with these risk factors should definitely avoid PPA regardless of the FDA's decision on this matter.

The FDA Advisory Committee's recommendation was based largely upon the results of a five-year study conducted at Yale University comparing 702 hemorrhagic stroke survivors under 50 with 1,376 similar control patients without a history of stroke.  The study found PPA increases stroke risk for young women (but not men) under two circumstances: within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason. Risk was highest with doses higher than 75 milligrams daily; these are the doses that dieters taking appetite suppressants were more likely to use.  First-time PPA use may temporarily raise blood pressure; this effect decreases as the body gets used to the drug.  While the study actually found few stroke patients who also took PPA, the results are statistically significant and suggest that, when taken by millions, PPA could possibly be the cause of 200 to 500 strokes a year in people under 50.  It should also be noted that the stroke patients were more likely to smoke, drink and have other stroke risks than the control group.

This study was sponsored by the Consumer Health Products Association (CHPA), which represents manufacturers of nonprescription medicines and dietary supplements.  This study was conducted in order to evaluate anecdotal reports of young women who had strokes within days of taking appetite suppressants. The FDA's records show only 44 reports of hemorrhagic stroke among PPA users in the past 30 years.  Most were women with an average age of 35. These cases represent only those cases reported to the FDA; FDA officials estimate that the agency learns of fewer than one in 10 serious side effects associated with drugs each year.

How does this affect you?
  • Avoid OTC appetite suppressants
  • Avoid OTC  cold preparations that contain PPA (phenylpropanolamine) if you:
  • Are female
  • Have high blood pressure
  • Smoke
  • Drink alcohol
  • Take blood thinning medications (e.g. coumadin)

If you take PPA for any reason, limit your dosage to under 75 mg/day.

**Children were not included in this study: Noted pediatrician, Dr. Alan Greene of DrGreene.com recommends that children avoid preparations containing PPA altogether. Parents should select preparations containing pseudoephedrine instead, he advises.

Stay tuned for further reports on the FDA's forthcoming decision.

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Created: 10/25/2000  -  Donnica Moore, M.D.

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