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
& 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
FDA's Nonprescription Drugs Advisory Committee recently discussed this
study and other information on phenylpropanolamine. The Committee determined
that there is an association between PPA and hemorrhagic stroke and recommended
that PPA not be considered safe for over-the-counter use.
For more information on this public health advisory, please see the items
FDA Talk Paper on Phenylpropanolamine
Public Health Advisory.
Subject: Safety of Phenylpropanolamine (PPA). 11/6/2000.
Questions and Answers about
Phenylpropanolamine (PPA). 11/6/2000.
Statement on Safety of Phenylpropanolamine (PPA). 11/6/2000.
FDA Letter to Manufacturers
of Drug Products Containing Phenylpropanolamine (PPA) dated 11/3/2000.
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.
The following medications contain Phenylpropanolamine:
Alka-Seltzer Plus Children's Cold Medicine Effervescent
Alka-Seltzer Plus Cold medicine (cherry or orange)
Alka-Seltzer Plus Cold Medicine Original
Alka-Seltzer Plus Cold & Cough Medicine Effervescent
Alka-Seltzer Plus Cold & Flu Medicine Effervescent
Alka-Seltzer Plus Cold & Sinus Effervescent
Alka Seltzer Plus Night-Time cold Medicine Effervescent
BC Allergy Sinus Cold Powder
BC Sinus Cold Powder
Comtrex Deep Chest Cold & Congestion Relief
Comtrex Flu Therapy & Fever Relief Day & Night
Contac 12-Hour Cold Capsules
Contac 12 Hour Caplets
Coricidin D Cold, Flu & Sinus
Dimetapp Cold & Allergy Chewable Tablets
Dimetapp Cold & Cough Liqui-Gels
Dimetapp DM cold & Cough Elixir
Dimetapp 4 Hour Liqui Gels
Dimetapp 4 Hour Tablets
Dimetapp 12 Hour Extentabs Tablets
Naldecon DX Pediatric Drops
Tavist-D 12 Hour Relief of Sinus & Nasal Congestion
Triaminic DM Cough Relief
Triaminic Expectorant Chest & Head Congestion
Triaminic Syrup Cold & Allergy
Triaminic Triaminicol Cold & Cough
Acutrim Diet Gum Appetite Suppressant Plus Diary
Acutrim Maximum Strength Appetite Control
Dexatrim Caffeine Free
Dexatrim Extended Duration
Dexatrim Vitamin C/Caffeine Free
CVS was contacted and confirmed the news report.
The CVS website address is http://www.cvs.com/otherCVS/drugDisclaimer.asp
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