PPA recall   PPA news
HOMEPAGE
PPA RECALL
PPA RISKS
NEWS LINKS
LEGAL INFORMATION
PPA FAQs
CONTACT US
BLOG
RESOURCES:
Local Orthodontists & Periodontists
Biological Dental Advice
Top Rated Oral Advice
Coaching: Botulinum Toxin Administration





 


PPA INJURY

FREQUENTLY ASKED QUESTIONS

On November 6, 2000, the FDA announced they were taking steps to remove PPA containing products from the market. PPA had been found in prescription and over the counter cold remedies and appetite suppressants for over 50 years. Previous warning signs were not acted upon until the 5-year Yale University study found the risk of hemorrhagic stroke in women taking PPA containing products was significantly increased. The PPA injury study found women ages 18-49 who took appetite suppressants containing PPA were 16 times more likely to have a hemorrhagic stroke than other women. Women who used cold or cough remedies containing PPA for the first time had a threefold increased risk of hemorrhagic stroke.

The FDA provided questions and answers regarding the safety of PPA. If you would like more information contact us to speak with a PPA injury lawyer.

What action is the FDA announcing today?
What is PPA?
Why is PPA unsafe when this product has been in use for many years?
Are there any population groups at higher risk when using products containing PPA?
What types of products contain PPA?
If a patient brings me, a pharmacist, a prescription containing PPA, should I fill it?
My family has been using products that contain PPA; is there any danger we will suffer PPA injury?
Is there another medicine that I can take in place of my medicine that contains PPA?
How will I know if my OTC products contain PPA?
How will I know if my prescription nasal decongestant or cough/cold products contain PPA?
If I have PPA questions about drug products whom can I call?
How can I report a PPA injury side effect?

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.

top

Why is PPA unsafe when this product has been in use for many years?
On May 11, 2000, FDA received results of a PPA injury 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 injury 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 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 for PPA injury. Because of continued reports to the FDA of hemorrhagic stroke associated with PPA injury and the results of the Yale study, we now feel that the risks of using PPA outweigh the benefits and recommend that consumers no longer use products containing PPA.

top

Are there any population groups at higher risk when using products containing PPA?
The Yale University PPA injury study showed that the risk of hemorrhagic stroke was found mostly in women; however, men may also be at risk.

top

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.

top

If a patient brings me, a pharmacist, a prescription containing PPA, should I fill it?
FDA has not said that such 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 PPA injury risks and benefits of taking the product as prescribed.

top

My family has been using products that contain PPA; is there any danger we suffer PPA injury?
In the Yale PPA injury 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.

top

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.

top

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.

top

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.

top

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

How can I report a PPA injury side effect?
FDA encourages anyone aware of a serious adverse PPA injury side effects, 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

 

PPA News

top