FDA ALERT:  Phenylpropanolamine (PPA) .

The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA.  In addition, FDA has issued a public health advisory concerning phenylpropanolamine hydrochloride. This drug is an ingredient used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.

Scientists at Yale University School of Medicine recently issued a report entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke:   Final Report of the Hemorrhagic Stroke Project."   This study reports that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women.  Men may also be at risk.  Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain PPA.

FDA’s Nonprescription Drugs Advisory Committee recently discussed this study and other information on phenylpropanolamine. The Committee  determined that there is an association between PPA and hemorrhagic stroke and recommended that PPA not be considered safe for over-the-counter use.

For more information on this public health advisory, please see the items below.

• FDA Talk Paper on Phenylpropanolamine (PPA).  11/6/2000.
• Science Background Statement on Safety of Phenylpropanolamine (PPA).  11/6/2000. 
• FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA) dated 11/3/2000. Posted 11/6/2000.
• Nonprescription Drugs Advisory Committee Meeting: Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug Products, (10/19/00).     
•  Yale Hemorrhagic Stroke Project:  Final Study Report.
  

FDA Questions and Answers
November 6, 2000

1. What action is the FDA announcing today?

The FDA has asked firms that market pharmaceutical or drug products containing phenylpropanolamine (fen-el-pro-pa-nol-a-mine) to voluntarily discontinue marketing them. We are also alerting consumers to the risks associated with the use of products containing phenylpropanolamine.

2. 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.

3. 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.

4. 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.

5. What types of products contain phenylpropanolamine?

Phenylpropanolamine is found in some prescription and OTC nasal decongestants and cough/cold products and OTC products for weight control.

6. 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.

7. Is there another medicine that I can take in place of my medicine that contains phenylpropanolamine?

Yes, there are other products on the market that do not contain phenylpropanolamine. Ask your pharmacist or health care provider what other products are available for your needs.

8. How will I know if my OTC 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.

9. 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.

10. If I have questions about drug products whom can I call?

Call 1-888 INFO FDA (1-888-463-6332)

11. How can I report a side effect with phenylpropanolamine?

FDA encourages anyone aware of a serious adverse reaction, including consumers, to submit a MedWatch report.

You can report an adverse event in two ways:

1. Visit www.fda.gov/medwatch and click on "How to Report" 

2. Call 1-800-FDA-1088

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