PPA FAQs

When the FDA announced they were beginning to take steps towards removing all PPA containing prescription and over the counter drugs on November 6, 2000, the FDA provided questions and answers concerning the safety of PPA. Please contact us if you would like more information from a PPA Injury Attorney.

What action is the FDA announcing today?
The FDA has asked firms that market pharmaceutical or drug products containing PPA to voluntarily discontinue marketing them. We are also alerting consumers to the risks associated with the use of products containing PPA.

What is PPA?
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.

Why is PPA unsafe when this product has been in use for many years?
On May 11, 2000, FDA received results of a PPA 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 PPA. PPA has been used for many years and a very small number of people taking the drug have had strokes. The Yale PPA study helped show that the number of people having strokes when taking PPA was greater than the number of people having strokes who were not taking PPA. Although the risk of PPA 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 PPA and the results of the Yale PPA study, we now feel that the risks of using PPA outweigh the benefits and recommend that consumers no longer use products containing PPA.

Are there any population groups at higher risk when using products containing PPA?
The Yale University PPA 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 PPA?
PPA is found in some prescription and OTC nasal decongestants and cough/cold products and OTC products for weight control.

If a patient brings me, a pharmacist, a prescription containing PPA, should I fill it?
FDA has not said that such PPA prescriptions should not be filled. However, you should make sure that both the prescriber and the consumer are aware that the drug contains PPA and have discussed the risks and benefits of taking the product as prescribed.

My family has been using products that contain PPA; is there any danger?
In the Yale PPA 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 PPA drug immediately and use an alternative drug product.

Is there another medicine that I can take in place of my medicine that contains PPA?
Yes, there are other products on the market that do not contain PPA. Ask your pharmacist or health care provider what other products are available for your needs.

How will I know if my OTC products contain PPA?
OTC drug products containing this ingredient may be identified by looking for PPA 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 PPA.

How will I know if my prescription nasal decongestant or cough/cold products contain PPA?
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 PPA is present.

If I have questions about drug products whom can I call?
Call 1-888 INFO FDA (1-888-463-6332) for questions on drugs containing PPA.

How can I report a side effect with PPA?
FDA encourages anyone aware of a serious adverse reaction, including consumers, resulting from PPA to submit a MedWatch report.

You can report an adverse PPA event in two ways:

• Visit www.fda.gov/medwatch and click on "How to Report"
  
• Call 1-800-FDA-1088

If you have suffered serious PPA side effects contact us to speak with a PPA injury attorney.