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Phenylpropanolamine & the FDA
Is PPA really harmful? Is it presently found in over-the-counter products?


"The FDA did not actually issue a mandatory recall of PPA-containing products, they just asked drug manufacturers to voluntarily stop selling products containing PPA."

On 6 November 2000, the U.S. Food and Drug Administration issued a warning that phenylpropanolamine, an ingredient found in many over-the-counter cold medications and diet aids, may cause strokes and thus should be avoided. Although the FDA did not issue a mandatory recall of PPA-containing products, they asked drug manufacturers to voluntarily stop selling products containing PPA and provide safer alternatives. As a result, most products that formerly included PPA have now been discontinued or reformulated without PPA while the FDA proceeds with the regulatory process necessary to remove all PPA-containing products from the market.

The following list is just an example of OTC cold and dietary aids that have in the past, contained Phenylpropanolamine:

Dietary Aids:
Acutrim
Dexatrim

Cold, Sinus & Flu Medications:
Alka-Seltzer Cold & Flu Products
Contac Cold Products
Dimetapp Cold & Flu Products
Coricidin D Cold, Flu & Sinus
BC Cold & Sinus Products
Comtrex Flu Therapy & Fever Relief
Naldecon DX Pediatric Drops
Permathene Mega-16
Robitussin CF
Tavist-D 12 Hour Relief of Sinus & Nasal Congestion
Triaminic Products

The product brands listed above and being cited in these circulated e-mails is now 3-5 years out of date and for the most part, PPA has been removed from those products. Since the FDA never actually issued a formal mandate banning the use of PPA, nor requiring manufacturers to halt the use of PPA in OTC drugs, it is suggested that consumers should check existing OTC medications in their medicine cabinets, as well as continue to check product ingredients before purchasing current OTC dietary aids & cold medications.

The FDA has noted:
"There is no comprehensive, updated list available from the FDA. The FDA is aware of emails circulating widely that list many products allegedly containing PPA. Those emails are no longer valid and should be ignored. Please read the labels of OTC products to determine if they contain PPA."

The FDA continues to answer PPA questions toll-free at (888) INFO-FDA. A direct line, although it is not toll-free, is (301) 827-4570. The FDA also has a Phenylpropanolamine (PPA) Information Page available on their web site. The FDA has advised that consumers go through their medicine cabinets, paying special attention to cold remedies and diet aids, and discard any medications that list phenylpropanolamine as one of their ingredients.

According to the FDA, "Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain PPA." The FDA warning came as a result of a May 2000 study conducted at Yale University School of Medicine, in which the Hemorrhagic Stroke Project found PPA to increase the risk of hemorrhagic stroke, a type of stroke characterized by bleeding in the brain. In October 2000, an FDA advisory committee confirmed the findings in the Yale study published by The New England Journal of Medicine, which suggested that PPA could raise the risk of stroke even in young people aged 18 to 49.

Not everyone is convinced that PPA poses nearly as much of a threat to consumers as claimed, and some critics have maintained the withdrawal was initiated by an overly cautious FDA based on flawed studies.

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