Products with PPA carry warnings in Australia, says TGA
10 November, 2000
Current concerns regarding phenylpropanolamine (PPA), which have resulted in a warning issued by the Food and Drug Administration (FDA) in the United States, had already been addressed in Australia in 1983 by the Therapeutic Goods Administration (TGA). The Australian warning followed a series of reports of severe high blood pressure attributed to phenylpropanolamine in high doses in appetite suppressants.
Since then, PPA-containing products have been required to carry a warning that they ‘can cause elevated blood pressure and interact adversely with other medications’. Also, products containing PPA are now available over the counter in only low doses (25 mg or less per dose) and are in the ‘pharmacist only’ category, meaning that they can only be bought from pharmacies after advice from the pharmacist. PPA products for slimming or containing doses higher than 25 mg are only available on prescription.
There are 6 products containing phenylpropanolamine available in Australia, 5 over-the-counter cough and cold medications and one prescription-only appetite suppressant.
The FDA in the US has requested that all companies voluntarily discontinue use of PPA in their products and stop marketing any products that contain it.
The FDA warning to consumers followed the results of a study conducted at Yale University School of Medicine, which was published in the New England Journal of Medicine 2000. The study assessed 2078 men and women between 18 and 49. The researchers concluded that PPA was an independent risk factor for haemorrhagic stroke in women, when it was used as an appetite suppressant or for first-time use as a cold or cough medication.
The researchers were unable to determine the risk for men as none of the male participants used PPA products to suppress appetite, and only two reported adverse reactions after first time use.
In Australia, the TGA recommends you check with your doctor, pharmacist or health professional if you are concerned about products containing phenylpropanolamine.
Last Reviewed: 10 November 2000
- 1. Kernan WN, Viscoli CM, Brass LM, Broderick JP, Brott T, Feldmann E, Morgenstern LB, Wilterdink JL, Horwitz RI. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med. 2000 Dec 21; 343(25): 1826-32.
2. Therapeutic Goods Administration
