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If a substance or drug is withdrawn in USA or Europe, it may not be withdrawn in
Australia. When overseas, you could unknowingly use an banned
product brought fromAustralian .
If a
substance may not be sold in the USA or Europe, it doesn't mean that chemical manufacturers may not sell it
anywhere else in the world. USA has a convenient law that allows manufacturers to sell USA banned
chemicals to foreign
countries. Be aware! The USA and Europeans considers Australia a foreign country!
An Example
Phenylpropanolamine recalled
Quoted in part from http://www.ppa-news.com/html/recall.html
"PPA" Recall
On November 6, 2000, the Food and Drug Administration (FDA) announced a ban on the sale of
phenylpropanolamine (PPA) in products that are sold over the counter. In addition, the agency
requested that all drug companies discontinue marketing products containing PPA.
The agency went one step further
and issued a public health advisory for phenylpropanolamine hydrochloride, the active ingredient
in PPA. This chemical is found in many over-the-counter (OTC) and prescription cold and cough
medications, nasal decongestants and OTC appetite suppressant and weight loss products.
PPA is
one of the most commonly used non-prescription medications.
PPA has been linked to a heightened risk of haemorrhagic stroke, a serious health condition marked
by bleeding into the brain or into the tissue surrounding the brain. Real concern followed the release
of a scientific study from Yale University that found 25 women between the ages of 18-49 had died after
taking appetite suppressants. Women were nearly 16 times more likely to experience a stroke within the
first three days of taking appetite suppressants containing PPA than those who did not take
PPA."
It goes on to say that at least five reports of haemorrhagic stroke involved PPA in cough, cold and flu
medications - check medications for phenylpropanolamine.
The list of brands and products is so large, you need to go to the web site to see them all.
Always check products for those letters PROP- if 'prop' forms part of
the name, avoid it in any preparation as a precaution.
Some preparations may have altered their formulas
and may no longer contain PPA. You may have an overseas visitor carrying these products, you may go
overseas yourself and need such a product or there may be old stock in the medicine cabinet.
Acutrim®,
Alka-Seltzer®,
Contac®,
Demazin®,
Dimetapp®, and Orthoxicol®
are some of the brand names of
products for cough, cold and flu treatment for adults and children have had phenylpropanolamine in them.
From the TGA (Therapeutic Goods Administration)
Web site: http://www.tga.gov.au/docs/html/ppa.htm
Phenylpropanolamine
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".
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.
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.
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