Phenylpropanolamine:Decongestant, Diet Aid or Stroke in a Bottle?
Volume X, Issue 10
Harold J. DeMonaco, M.S., Director of Drug Therapy Management

On November 6, 2000, the FDA advised manufacturers of products containing phenylpropanolamine (PPA) to cease manufacture of the popular decongestant/appetite suppressant. (http://www.fda.gov/bbs/topics/ANSWERS/ANS01051.html) The FDA move was prompted by the final report of the Hemorrhagic Stroke Project http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3647b1_tab19.doc. This industry-sponsored case-controlled study examined men and women, aged 18 to 49 years, hospitalized with a subarachnoid hemorrhage or intracerebral hemorrhage in four geographic regions of the U.S. from December 1994 to July 1999. Control subjects were recruited at random in a 2:1 ratio as compared to stroke patients. A total of 702 cases were interviewed along with 1376 controls matched for age, gender, race and telephone exchange. A subject was classified as exposed to phenylpropanolamine if they had ingested PPA within 3 days of their stroke. The adjusted odds ratio for people exposed to PPA used as an appetite suppressant and stroke within the three-day window was 15.92. For women, the odds ratio was 16.58. No discernible factors other than gender and dose were identifiable which would allow for risk stratification. The FDA’s Non Prescription Drug Advisory Committee recommended discontinuation of the popular diet aid and decongestant after reviewing the Stroke Project report. The FDA did not issue a product recall so phenylpropanolamine-containing products are still available.

Phenylpropanolamine has been available in the U.S. for decades as a decongestant and is present in both over-the-counter and prescription products such as Entex LA. While the risk associated with doses of phenylpropanolamine less than 75mg daily appears to be reduced, there still appears to be a significant increase in risk of stroke. For that reason, the FDA moved on all products containing phenylpropanolamine rather than just dietary supplements. The FDA advised consumers that they should stop taking any products containing phenylpropanolamine. Many pharmacies have already removed phenylpropanolamine products from their shelves. The MGH Outpatient Pharmacy will no longer dispense Entex LA or any other phenylpropanolamine-containing products.

Unfortunately, the alternatives to phenylpropanolamine used as a decongestant or appetite suppressant aren’t without some risk. Despite the fact that pseudoephedrine and phenylephrine have not been implicated in hemorrhagic stroke, both are alpha-adrenergic agonists and can, at least on a theoretical basis, increase blood pressure when taken at usual doses. Local administration of decongestants appears to have the lowest risk as compared to systemic use. Dietary supplements containing ephedrine (also known as ma huang and Chinese ephedra) may become popular substitutes for phenylpropanolamine-containing Acutrimâ and Dexatrimâ . Ma huang has been implicated in dozens of adverse events reported to the FDA. Because these products are protected by the Dietary Supplement Health and Education Act, the FDA has limited powers to remove them from interstate commerce at the present time.

 

Advice to patients:

-For short term relief of nasal congestion, saline, phenylephrine (Neo-Synephrine and others) or oxymetazoline (Afrin and others) nasal spray appear to be safe if used brief periods. Prolonged use of decongestant nasal sprays may lead to rebound nasal congestion.