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