November 9, 2000

Dear 4 Your Health Visitor,

You may have heard from recent news reports that on November 6, 2000 the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory. Specifically, the FDA has requested that all drug companies who manufacture over-the-counter (OTC) products that contain the nasal decongestant and appetite suppressant phenylpropanolamine (PPA) voluntarily discontinue the manufacture and marketing of these products. We would like to emphasize the importance of this advisory to both you and your family.

PPA has been available in the United States for many years. However, the FDA has received adverse event reports that appeared to associate PPA with an increased risk of hemorrhagic stroke. A stroke is often referred to as a "brain attack" and is a potentially serious event. A hemorrhagic stroke occurs when there is bleeding in the brain. Symptoms of a stroke can include sudden confusion, difficulty speaking, trouble with vision, loss of balance or coordination, numbness or weakness on one side of the face or the body, and a sudden severe headache without any known cause.

Because of the potential severity of this condition, the FDA worked with drug manufacturers to determine a research plan to see if an association between PPA and hemorrhagic stroke actually existed. The Yale University School of Medicine coordinated the research study and many cases of hemorrhagic stroke, as well as patterns of medication use before the stroke occurred were reviewed. The results of the study led to the conclusion that the use of PPA appeared to increase the risk for hemorrhagic stroke, especially in women (though men were also found to be at risk) and seemed to occur mostly during the first three days that PPA was used.

Hemorrhagic stroke does not commonly occur in the general population. However, as noted above, when it occurs it is a very serious medical condition. The role of the FDA is to determine the safety and effectiveness of medications. Much of the decision is based on a comparison of the benefit of the medication against the potential risk to the health of the consumer. In the case of PPA, the FDA has announced that the benefit of this medication for nasal decongestion and weight loss does not outweigh the potential risk of hemorrhagic stroke. Therefore, the FDA no longer considers PPA to be a safe medication for continued use. Though the FDA has not ordered pharmacies to remove over-the-counter PPA products from shelves, we feel it is in the best interest of you, that all pharmacies voluntarily remove these products from their shelves. At the end of this Alert we will list all On-Line Pharmacies that we have found to no longer sell any nonprescription nasal decongestants or appetite suppressants that contain PPA.

You can determine if any OTC products you have at home contain phenylpropanolamine by reading the label of your medication container, or you can ask your health care provider. Alternatives to PPA are available. We encourage you to ask your doctor for a recommendation of which product is best for you.

If you have any additional questions, please ask the health care provider who is most familiar with your medical history. We hope this letter has helped your understanding of the importance of the FDA Public Health Advisory and why we at 4 Your Health are working to remove all OTC products that contain PPA at any site that we link to.