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Phenylpropanolamine (PPA) Information Page

HEALTH ALERT!

 

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 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 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.

 

Please discard any of these medications as soon as possible!

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 Elixir

Dimetapp 4 Hour Liqui Gels

Dimetapp 4 Hour Tablets

Dimetapp 12 Hour Extentabs Tablets

Naldecon DX Pediatric Drops

Permathene Mega-16

Robitussin CF

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

Supplements:

Acutrim Maximum Strength Appetite Control

Dexatrim Caffeine Free

Dexatrim Extended Duration

Dexatrim Gelcaps

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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