FDA FAQs

The following frequently asked questions (FAQs) are based on questions provided by consumers regarding use of products containing PPA:

This product has been on the market for years, why didn't the FDA warn consumers before?

Although there were earlier reports about a connection between PPA and stroke, it wasn't until the 1990s that they began to surface in alarming numbers. Then the Yale University School of Medicine study released on May 11, 2000 definitively established the connection between PPA and hemorrhagic stroke (bleeding of the brain).

Based on that study, and continued reports of hemorrhagic stroke associated with its use, the FDA decided that the risks of using PPA outweigh the benefits and recommended consumers stop using products containing the ingredient

Who is most at risk for harm caused by using PPA?

According to the Yale University Study, women showed a greater risk of hemorrhagic stroke than men, although both groups are susceptible.

What types of products contain PPA?

PPA is most often found in both perscription and over-the-counter nasal decongestants, cough/cold medicines and weight control products.

Do I have a responsibility as a pharmacist to question prescriptions for drugs containing PPA that I receive?

You have a responsibility to inform both the consumer and whoever prescribed the drug of the risks of possible PPA injury. However once you have explained these risks, you may fill the prescription as written.

If my family is currently using products containing PPA, should we stop?

Because the risk is serious, you are best advised to stop the medication and use an alternative immediately.

What alternative medications are available that do not contain PPA?

Your pharmacist or doctor can help you find an alternative medication that adequately addresses your needs but does not contain PPA.

How will I know if my over-the-counter and prescription products contain PPA?

Read labels carefully. PPA (phenylpropanolamine) will be listed among the active ingredients in over-the-counter drugs. If you're still not sure, ask your pharmacist to help you determine if a drug contains PPA.

Is there an expert resource available for questions regarding PPA?

Call 1-888 INFO FDA (1-888-463-6332) for all PPA questions. You can also contact HendlerLaw 24 hours a day at 1-800-443-6353 or e-mail us at help@ppa-advice.com. We are happy to assist you.

If I have suffered a stroke after taking a product containing PPA, what should I do?

You should submit a MedWatch report to the FDA by either:

  1. Visiting www.fda.gov/medwatch and click on "How to Report"
  2. Calling 1-800-FDA-1088

You should also consider protecting your legal rights because they could expire under your state's statute of limitations. If you have questions about your right to compensation, contact HendlerLaw 24 hours a day at 1-800-443-6353 or e-mail us at help@ppa-advice.com. Or click here to request a free case evaluation.

  

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