What Are the Risks of Phenylpropanolamine to Women and Children?

Blaine P. Carmichael, MPAS, PA-C

Disclosures

February 22, 2001

Question

What is the basis of the recently released precaution regarding the pediatric use of drugs containing phenylpropanolamine?

Hanan Soliman-Lee, PA-C

Response from Blaine P. Carmichael, MPAS, PA-C

The most common side effects of phenylpropanolamine (PPA) are hypertension and headache. In combination with caffeine, ephedrine, or an antihistamine, PPA can cause sustained tachycardia. Its escalated risk of stroke increases with age and with the use of alcohol, smoking, and anticoagulants.

In a recent study, PPA was found to be an independent risk factor for hemorrhagic stroke in women, responsible for perhaps 200-500 strokes each year.[1] Never approved for use in children under the age of 6 years, PPA is an ingredient used in prescription and over-the-counter (OTC) drug products as a nasal decongestant to relieve stuffy nose or sinus congestion, and in OTC weight control drug products to control appetite. On November 6, 2000, in response to a study conducted by Yale University,[2] the FDA ordered that all OTC medications that included PPA be removed from the market. The FDA also requested that all manufacturers using PPA reformulate their products. Although manufacturers insisted that PPA did not pose a health risk, the FDA continued its investigation of hemorrhagic strokes in young women.

PPA is a sympathomimetic drug that causes tachycardia and has now been shown to cause seizures, strokes, and myocardial infarction. Cerebral vasculitis, in combination with hypertension associated with PPA, has resulted in hemorrhagic strokes.[2]The risk to the average person using diet pills or treating a cold or flu with products that include PPA as an ingredient is minimal, according to FDA and Yale University researchers. However, it was noted that the hemorrhagic stokes related to PPA, although rare, have occurred mainly in young women.[2] The FDA estimates that out of 130 million people each year between the ages of 18 and 49, only 10,400 suffered a hemorrhagic stoke.[1]

Common OTC medications that contained phenylpropanolamine include: Tavist-D cold, allergy and sinus tablets, Dimetapp cold medicine, Triaminic DM cough syrup, Dexatrim weight products, Acutrim weight control products, Robitussin CF cough syrup, Contac 12-hour, and Permathene weight control tablets.

You may have patients who ask for advice about using PPA for weight loss or congestion. The following online references will provide guidance in suggesting alternative products.[3,4]

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....