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Food and Drug Administration Public Health Advisory Subject: Safety of Phenylpropanolamine
November 6, 2000 (Talk Paper)

FDA ISSUES PUBLIC HEALTH WARNING ON PHENYLPROPANOLAMINE

FDA, today, is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

FDA today issued a public health advisory concerning the risk of hemorrhagic stroke, or bleeding into the brain, associated with phenylpropanolamine hydrochloride.

Phenylpropanolamine is an ingredient used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.

Adverse events reported with these products led to concerns that this ingredient might increase the risk of hemorrhagic strokes.

Manufacturers of products containing phenylpropanolamine worked with FDA to plan a research program to clarify whether any increase in risk exists.

Scientists at Yale University School of Medicine conducted the study in which the researchers found an association between phenylpropanolamine use and stroke in women. 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. Men may also be at risk.

The Nonprescription Drugs Advisory Committee met on October 19 to discuss safety issues related to phenylpropanolamine use. The committee reviewed Yale's Hemorrhagic Stroke Project results and concluded that phenylpropanolamine cannot be considered to be safe for continued use.

FDA believes that although the risk of hemorrhagic stroke is very low, even with phenylpropanolamine use, the conditions for which these products are used do not appear to warrant an increased risk of this serious event from using this drug. We advise consumers to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.

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Food and Drug Administration Public Health Advisory Subject: Safety of Phenylpropanolamine
November 6, 2000

The Food and Drug Administration (FDA) is issuing a public health advisory concerning phenylpropanolamine hydrochloride. This drug is widely used as a nasal decongestant (in over-the-counter and prescription drug products) and for weight control (in over-the-counter drug products). FDA is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

Phenylpropanolamine has been marketed for many years. A recent study reported that taking phenylpropanolamine increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain phenylpropanolamine.

FDA's Nonprescription Drugs Advisory Committee (NDAC) recently discussed this study and other information on phenylpropanolamine. NDAC determined that there is an association between phenylpropanolamine and hemorrhagic stroke and recommended that phenylpropanolamine not be considered safe for over-the-counter use.

Although this 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. FDA does not consider the conditions for which phenylpropanolamine is used (over-the-counter or by prescription) as justifying the risk of this serious event. Other products are available for use.

In the meantime, consumers can identify over-the-counter cough-cold, nasal decongestant, and weight control products containing this ingredient by looking for "phenylpropanolamine" in the list of active ingredients on the label.

Consumers can check with their health care provider or pharmacist to see whether their prescription cough-cold or nasal decongestant product contains phenylpropanolamine. We advise consumers to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.

 

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