Phenylpropanolamine or PPA is an ingredient used in prescription and over the counter drug products such as nasal decongestants and weight control products. In May 2000 the Yale University School of Medicine submitted a study to the FDA that showed an increase risk of hemorrhagic stroke in people who were taking PPA. Hemorrhagic strokes cause bleeding in the brain. The Yale University School of Medicine study included a long history of published serious adverse events going back to 1979.
In addition, PPA is known to cause cerebral vasculitis. Cerebral vasculitis is a severe inflammation of the blood vessels in the brain. When combined with the blood pressure raising effects of PPA, cerebral vasculitis can result in cerebral or subarachnoid brain hemorrhage and stroke. Due to the results of this study, in November 2000, the Food and Drug Administration took Phenylpropanolamine (PPA) off the market.
Products Containing PPA:
- Robitussin CF Cough Syrup
- Dimetapp Cold Medicine
- Triaminic DM Cough Syrup
- Permathene Weight Control Tablets
- Dexatrim Weight Products
- Acutrim Weight Control Products
- Tavist D Cold, Allergy and Sinus Tablets
- Alka-Seltzer Cold
- Bayer Cold
- Triaminic, Allergy Relief
- Sucrets Cold
PPA has been available for over half a century. Studies show that Americans take 6 billion doses of the ingredient each year in a wide range of prescription and over-the-counter products. By some calculations there are as many as 400 over-the-counter products containing PPA.
Symptoms of Phenylpropanolamine Side Effects
- Acute psychosis
- Acute renal failure
- Heart damage
- Hemorrhagic strokes
- Cerebral vasculitis
- Cerebral or subarachnoid brain hemorrhage
There have been 51 confirmed reports to the FDA of hemorrhagic stroke resulting from the ingestion of PPA. However, analysts now estimate that 200-500 strokes occurred per year in women age 18-49 due to PPA. The Yale study concluded that women aged 18 to 49 who had taken appetite suppressants with PPA were 16 times more likely to suffer a hemorrhagic stroke. In addition, among men and women taking a cough or cold remedy containing PPA for the first time, the risk of a stroke was three times higher than normal.
On November 6, 2000, in response to the Yale study, the FDA ordered that all over-the-counter manufacturers remove PPA from their products. The FDA determined that the conditions for which PPA is used did not justify the risk of serious harm posed by the drug. The FDA concluded that PPA “cannot be considered to be safe for continued use”.FDA Talk Paper, 11/6/00.