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FDA recall of PHENYLPROPANOLAMINE
2002

All drugs containing PHENYLPROPANOLAMINE are being recalled. You may want to try calling the 800 number listed on most drug boxes and inquire about a REFUND. Please read this CAREFULLY. Also, please pass this on to everyone you know.

STOP TAKING anything containing this ingredient. It has been linked to increased hemorrhagic stroke (bleeding in brain) among women ages 18-49 in the three days after starting use of medication. Problems were not found in men, but the FDA recommended that everyone (even children) seek alternative medicine.

The following medications contain Phenylpropanolamine:

Acutrim Diet Gum Appetite Suppressant Acutrim Plus Dietary Supplements Acutrim Maximum Strength Appetite Control 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 Alka-Seltzer Plus Cold &Sinus Effervescent Alka Seltzer Plus Night-Time Cold Medicine BC Allergy Sinus Cold Powder BC Sinus Cold Powder Comtrex Flu Therapy &Fever Relief

Contac 12 Hour Caplets Coricidin D Cold, Flu &Sinus Day &Night Contac 12-Hour Cold Capsules Dexatrim Caffeine Free Dexatrim Extended Duration Dexatrim Gelcaps Dexatrim Vitamin C/Caffeine Free Dimetapp Cold &Allergy Chewable Tablets Dimetapp Cold &Cough Liqui-Gels Dimetapp DM Cold &Cough Elixir Dimetapp Elixir Dimetapp 4 Hour Liquid 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 Triaminic Syrup Cold &Allergy Triaminic Triaminicol Cold &Cough ....

I just found out and called the 800# on the container for Triaminic and they informed me that they are voluntarily recalling the following medicines because of a certain ingredient that is causing strokes and seizures in children:

Orange 3D Cold &Allergy Cherry (Pink) 3D Cold &Cough Berry 3D Cough Relief Yellow 3D Expectorant

They are asking you to call them at 800-548-3708 with the lot number on the box so they can send you postage for you to send it back to them, and they will also issue you a refund.

If you know of anyone else with small children, PLEASE PASS THIS ON. THIS IS SERIOUS STUFF!

DO PASS ALONG TO ALL ON YOUR MAILING LIST so people are informed. They can then pass it along to their families.

To confirm these findings please take time to check the following:

URL: Phenylpropanolamine Information Page http://www.fda.gov/cder/drug/infopage/ppa/default.htm

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. 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.

We have received numerous requests for a list of products containing PPA. In response to the request made by FDA in November 2000, many companies have voluntarily reformulated and are continuing to reformulate their products to exclude PPA while FDA proceeds with the regulatory process necessary to remove PPA from the market. Therefore, there is no comprehensive, updated list available from FDA. FDA is aware of emails circulating widely that list many products allegedly containing PPA. Those emails are no longer valid and should be ignored. Please read the labels of OTC products to determine if they contain PPA. (Paragraph added 2/20/2002)

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.

From the IICPH Resource Centre www.iicph.org

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