
The FDA has asked firms that market pharmaceutical or drug products containing phenylpropanolamine (PPA) to voluntarily discontinue marketing them. The agency is also alerting consumers to the risks associated with the use of products containing PPA.
PPA is an ingredient used in prescription and over-the-counter drug products as a nasal decongestant to relieve stuffy nose or sinus congestion and in over-the-counter weight control drug products to control appetite.
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 PPA. PPA has been used since 1936 and a small number of people taking the drug have had strokes. The Yale 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 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 study, the agency now feels that the risks of using PPA outweigh the benefits.
The Yale University study showed that the risk of hemorrhagic stroke was found mostly in women; however, men may also be at risk.
PPA is found in some prescription and over-the-counter nasal decongestants and cough/cold products and over-the-counter products for weight control.
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 small, for this reason the FDA suggests you stop taking the drug immediately and use an alternative drug product.
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.
Over-the-counter 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 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.
Call 1-888 INFO FDA (1-888-463-6332).
That depends largely on your particular circumstance. You must have suffered some type of injury to win such a lawsuit. Just because you may have taken a product that contained PPA may not be sufficient for a court to rule in your favor. However, if you believe that you suffered some adverse reaction to PPA, such as a stroke, you may have a case. Many lawsuits have already been filed and more are expected. If you would like to explore the possibility of filing suit, it may be important for you to contact an attorney who can help you protect your legal rights. Only a licensed attorney can evaluate whether you have a case that is worth pursuing. Keep in mind however that there may be time limits (Statute of Limitations) which affect your ability to sue.
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