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Phenylpropanolamine (PPA) Recall

Netlore Archive: Forwarded emails warn that non-prescription medicines containing phenylpropanolamine hydrochloride (PPA) may have adverse health effects.

Description: Email rumor
Circulating since: Nov 2000
Status: Outdated

Example:
Email text contributed by Nancy, Dec. 6, 2000:

You may have heard this, or noticed that these products have been removed from the shelves.

Discard these Medications

subject: Phenylpropanolamine

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:

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 Nighttime 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
Dietary Supplements
Acutrim Maximum Strength Appetite Control
Dexatrim Caffeine Free
Dexatrim Extended Duration
Dexatrim Gelcaps
Dexatrim Vitamin C/Caffeine Free

Please discard any of these medications as soon as possible


Update: Most if not all of the products listed above which formerly contained phenylpropanolamine hydrochloride have been reformulated to eliminate the ingredient. Consumer questions about phenylpropanolamine and its potential health hazards may be directed to the U.S. Food and Drug Administration at 1-888-INFO-FDA.

Some manufacturers of over-the-counter medicines containing phenylpropanolamine have offered refunds to consumers who purchased the products before they were voluntarily recalled in late 2000. To inquire about the availability of such refunds, dial the 800-number for consumer questions listed on the product packaging.

Analysis: This email has it mostly right. In November 2000, the FDA issued a public health advisory about phenylpropanolamine hydrochloride (PPA), the drug mentioned in the email. This drug is found in many over the counter (OTC) medicines, specifically in cold and flu remedies, as well as appetite suppressants. The drug will likely be banned, but because this process takes time, the FDA issued the health advisory in the meantime and manufacturers are voluntarily recalling and/or reformulating medicines containing PPA.

The main problem with this drug is that it elevates your risk of having a hemorrhagic stroke, especially with (but not limited to) first time use among women. Because the uses of PPA are not serious enough to warrant taking even that small chance, the FDA recommends that you stop taking any medications containing the drug.

Rather than looking at a limited list such as the one contained in the above email, you'd be better off checking the package of any cold, flu or appetite suppressant medication for the drug, which will appear in the list of active ingredients and may be listed as phenylpropanolamine, phenylpropanolamine hydrochloride, or phenylpropanolamine bitartrate. Many manufacturers offer several formulations of their cold and flu remedies, some of which do not contain PPA. Pseudoephedrine is an effective alternative to PPA for use in cold and flue preparations, but unfortunately, there is no approved alternative OTC drug for use in appetite suppressants. Therefore, if you are using any OTC medications to suppress your appetite for weight loss or other reasons, you should stop using the medicine and talk to your doctor about getting a prescription drug instead. Additionally, some prescription decongestants and cold and flu preparations contain PPA, so if you are using any prescription medicines for these purposes, talk to the prescribing doctor to see if you should continue using the medicine.

One word of caution: Though the email states your risk is for "increased hemorrhagic stroke (bleeding in brain) among women ages 18-49 in the three days after starting use of medication," don't think you are safe if you've used the drug for longer than three days. The three-day window was merely one of the guidelines used in the study that prompted the health advisory; for the study, they defined PPA exposure as having used PPA within three days prior to the stroke. Risk of stroke may be present after three days of use. For detailed information, see the final report of the Hemorrhagic Stroke Project, Web-published by the FDA.

As always, your best resources for reliable information on medicines and medical conditions are your own physician and pharmacist.

~ Carla Homan


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Sources and further reading:

Phenylpropanolamine (PPA) Information Page
U.S. Food & Drug Administration


Last updated: 11/09/10


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