INDICES> Products containing Pseudoephedrine (3)

[kae <tingkae@mail.hukm.ukm.my>]

INDICES> Products containing Pseudoephedrine (3)
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Dear Mary,

Here's the information and links from FDA:

Phenylpropanolamine (PPA) Information Page
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The Food and Drug Administration (FDA) is taking steps to remove
phenylpropanolamine (PPA) from all drug products and has requested that all
drug companies discontinue marketing products containing PPA.  In addition,
FDA has issued a public health advisory concerning phenylpropanolamine
hydrochloride. This drug 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.

Scientists at Yale University School of Medicine recently issued a report
entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke:   Final Report
of the Hemorrhagic Stroke Project."   This study reports that taking PPA
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 PPA.

FDA's Nonprescription Drugs Advisory Committee recently discussed this Yale
study along with additional information on phenylpropanolamine. The
Advisory Committee determined that there is an association between PPA and
hemorrhagic stroke.  It recommended that PPA be considered not safe for
over-the-counter use.

For more information on this public health advisory, please see the items
below.

FDA Talk Paper on Phenylpropanolamine (PPA).  11/6/2000. 
Public Health Advisory.  Subject:  Safety of Phenylpropanolamine (PPA).
11/6/2000. 
Questions and Answers about Phenylpropanolamine (PPA).  11/6/2000. 
Science Background Statement on Safety of Phenylpropanolamine (PPA).
11/6/2000.  
FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine
(PPA) dated 11/3/2000.  Posted 11/6/2000. 
Nonprescription Drugs Advisory Committee Meeting: Safety Issues of
Phenylpropanolamine (PPA) in Over-the-Counter Drug Products, (10/19/00).
This link leads to the meeting agenda, roster, questions, presentation
slides, and briefing information, including the Yale Hemorrhagic Stroke
Project:  Final Study Report

[Note, the above can be found at the website link: 
http://www.fda.gov/cder/drug/infopage/ppa/default.htm]

Because of that, phenylpropanolamine-containing products have also been
withdrawn from the malaysain market. Pseudoephedrine-containing products
are still available however and I have not heard of any problems with it,
perhaps someone else can comment on that?

Best regards and God bless, our love and prayers are with our american
e-druggers and all who have been affected by the tragedies,

kae :)
Ms. Ting Kae, MRPharmS
Drug Information Pharmacist
Drug Information Centre
Pharmacy Department
Hospital Universiti Kebangsaan Malaysia
Jalan Yaacob Latif, Bandar Tun Razak
56000 Cheras, Kuala Lumpur
Malaysia
Tel: 603-9702154 or 9733333 x2154/2156
Fax: 603-9737151
Email: tingkae@mail.hukm.ukm.my


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