Do you have any Phenylpropanolamine? FDA drug recall!

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A coworker just sent this around. Just a notice in case anyone is interested. ----- Check out the FDA website for more information:

http://www.fda.gov/cder/drug/infopage/ppa

All drugs containing Phenylpropanolamine are being recalled. CVS Pharmacy has a sign stating that all drugs containing Phenylpropanolamine have been pulled from their shelves. You may want to try calling the toll-free number listed on most drug boxes and inquire about a refund.

Phenylpropanolamine 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 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 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 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 Congestion Triaminic Syrup Cold & Allergy Triaminic Triaminicol Cold & Cough

-- Anonymous, February 07, 2001

Answers

That would explain the cold medicine commercials lately with the disclaimers, "No PPA!"

I'll probably have to clean out most of my cupboard.

-- Anonymous, February 07, 2001


Phenylpropanolamine is the only thing that helps my sinus infections. Pseudoephedrine does nothing for me. For the past five years or so I've relied on Entex, a prescription medicine containing PPA, or else Triaminic, which also has it. (Most of the drugs you've listed above haven't had PPA for a while ... I know, because I'm always looking for it and I always check the ingredients on my cold medicines.)

I don't want to have a stroke, but this recall totally bums me out. I only have a few things left with PPA, and I'm not throwing them away.

-- Anonymous, February 07, 2001


I'll save mine for you, then. I don't use anything more than echinacea and vitamin C anymore...

-- Anonymous, February 07, 2001

Has it been recalled entirely, or only as an over-the-counter ingredient?

-- Anonymous, February 07, 2001

The link posted above did not work, and PPA is not listed on the FDA's page of recent (past 60 days) recalls. In fact, it's not listed in the archive, either. The FDA earlier called for a voluntary recall of both prescription and OTC versions, and indicated that eventually the drug will be banned altogether.

The most recent info available on the FDA website is the voluntary recall.

-- Anonymous, February 07, 2001



Odd, I was able to get to the page okay. You can get to it from the main http://www.fda.gov page- select Drugs on the lefthand column and then there is a link to PPA info on the right hand side of that page. It takes you to the FDA's Center for Drug Evaluation and Research. Looking around on the main FDA page, I have to say I misspoke. They have not offically recalled it but it looks like there is a health advisory out and that they are urging voluntary discontinuation of the drug. Sorry that I posted that it was an official recall, although it looks like it is not long for the OTC world.

The main gist of the text on the page (there are a lot of links to studies and stuff) is:

"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."

-- Anonymous, February 07, 2001


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