What is phenylpropanolamine?
Phenylpropanolamine 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.
Why is phenylpropanolamine unsafe when this product has been in use for many years?
On May 11, 2000, FDA received results of a study conducted by scientists at Yale University School of Medicine that showed an increased risk of hemorrhagic stroke (bleeding of the brain) in people who were taking phenylpropanolamine. Phenylpropanolamine has been used for many years and a very small number of people taking the drug have had strokes. The Yale study helped show that the number of people having strokes when taking phenylpropanolamine was greater than the number of people having strokes who were not taking phenylpropanolamine. Although the risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk. Because of continued reports to the FDA of hemorrhagic stroke associated with phenylpropanolamine and the results of the Yale study, we now feel that the risks of using phenylpropanolamine outweigh the benefits and recommend that consumers no longer use products containing phenylpropanolamine.
Are there any population groups at higher risk when using products containing phenylpropanolamine?
The Yale University study showed that the risk of hemorrhagic stroke was found mostly in women; however, men may also be at risk.
What types of products contain phenylpropanolamine?
Phenylpropanolamine is found in some prescription and over-the-counter nasal decongestants and cough/cold products and OTC products for weight control.
My family has been using products that contain phenylpropanolamine; is there any danger?
In the Yale study, the increased risk of hemorrhagic stroke was detected, among women using the drug for weight control and for nasal decongestion, in the 3 days after starting use of the medication. While the risk of hemorrhagic stroke is very small, for this reason we suggest you stop taking the drug immediately and use an alternative drug product.
How will I know if my over-the-counter products contain phenylpropanolamine?
OTC drug products containing this ingredient may be identified by looking for “phenylpropanolamine” in the list of active ingredients on the label. If you are still unsure, check with your pharmacist to help you determine if a product contains phenylpropanolamine.
How will I know if my prescription nasal decongestant or cough/cold products contains phenylpropanolamine?
If you are using a prescription nasal decongestant or cough/cold product you should talk to your pharmacist or health care provider to determine if phenylpropanolamine is present.
Do phenylpropanolamine users have a right to be compensated for any health problems caused by PPA?
If PPA (phenylpropanolamine) has caused you or a loved one significant physical damage, you may be entitled to a large compensatory award. You must protect those legal rights before they lapse by passage of time and are barred by various states’ statutes of limitations. You should contact an attorney to evaluate your rights. Many valuable legal rights are lost everyday because of people’s failure to take legal precautions.