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Safety of Phenylpropanolamine
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.
From the Australian Government Department of Health and Aging Therapeutic Goods Association site:
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Phenylpropanolamine
7 March 2006
On 6 November 2000 the US Food and Drug Administration (FDA) issued a "Public Health Advisory" statement notifying that it was "taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine" <http://www.fda.gov/bbs/topics/ANSWERS/ANS01051.html>.
The statement followed advice from the FDA's Non-prescription Drugs Advisory Committee that there is an association between phenylpropanolamine and haemorrhagic stroke and that phenylpropanolamine not be considered safe for over-the-counter use. The FDA advised that the risk of haemorrhagic stroke was "very low" but there were significant concerns because of the seriousness of a stroke and the inability to predict who was at risk. Further information is available on the FDA's Phenylpropanolamine Information Page <http://www.fda.gov/cder/drug/infopage/ppa/default.htm>.
On 22 December 2005 the FDA issued a notice of proposed rulemaking for over-the-counter (OTC) nasal decongestant and weight control products containing phenylpropanoloamine preparations. This proposed rule reclassifies phenylpropanolamine as nonmonograph (Category II) not generally recognised as safe and effective.
In Australia, substantial action to limit the availability of many of the products of concern to the US FDA was taken in 1983. This followed a number of Australian reports of episodes of severe high blood pressure attributed to high doses of PPA in appetite suppressant products. Since that time PPA has only been available in cough and cold products from pharmacies in relatively low doses (25mg or less per dose). Specific label warnings were required.
Since 1984 there has been only one Australian adverse drug reaction report to the TGA and that report did not relate to high blood pressure or stroke. This provides some assurance that the current concerns in the US were largely dealt with in Australia in 1983.
In June and July of 2001 the last remaining products containing PPA were voluntarily withdrawn from the Australian market by their sponsors. There are now no products containing PPA authorised for supply in Australia.
The TGA has become aware of information originating from the US regarding the PPA situation that has been circulating widely in the Australian community via email messages. It is not immediately apparent to recipients that this information relates to the US market, not Australia, particularly since some of the brand names mentioned, such as Dimetapp and Robitussin, are familiar to Australian consumers. As a result people have been misled into believing that certain products mentioned in these email messages contain PPA and are subject to drug recalls in Australia. This is not the case; there are no drug recalls in force in Australia relating to PPA and no products containing PPA on the Australian market.
If consumers have concerns about any medicines, they are encouraged to discuss these concerns with their doctor or pharmacist.
