have i mentioned that i have been taking alka-seltzer cold medicine that's expired?
oh, did i mention that it's also on that list of drugs that've been recalled?
well, at least my headache will have subsided
Public Health Advisory and Recall of Products Containing Phenylpropanolamine (PPA)
You'll notice some empty shelves at the local drugstore as manufacturers of several over-the-counter (non-prescription) cold remedies and diet drugs recall products containing the chemical phenylpropanolamine hydrochloride (PPA).
The Food and Drug Administration (FDA) issued a public health advisory recommending that consumers not take products containing PPA. This drug is widely used as a nasal decongestant and for weight control. And the FDA is taking steps to remove PPA from all drug products and has requested that all drug companies discontinue marketing products containing PPA.
PPA has been marketed for many years and a very small number of people taking the drug have had strokes, but a recent study by scientists at Yale University reported that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. The Yale study helped show that the number of people having strokes when taking phenylpropanolamine was greater than the number of people having strokes who were not taking phenylpropanolamine.
Although this risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of the adverse event (the irreversible outcome) and the inability to predict exactly who is at risk. The increased risk of hemorrhagic stroke was detected among women using the drug for weight control and for nasal decongestion in the 3 days after starting use of the medication, but men may also be at risk. FDA does not consider the conditions for which PPA is used as justifying the risk of this serious event. Alternate nasal decongestants which do not contain phenylpropanolamine are available both with and without prescription. Many manufacturers will likely reformulate their products so that they do not contain PPA.
You can identify over-the-counter cough-cold, nasal decongestant, and weight control products containing this ingredient by looking for "phenylpropanolamine" in the list of active ingredients on the label. Check with your health care provider or pharmacist to see whether your prescription cough-cold or nasal decongestant product contains phenylpropanolamine, and discuss alternative over-the-counter and prescription products with your health care providers or pharmacist.
A list of products containing PPA was supplied to news media by the Consumer Healthcare Products Association, but keep in mind that this list may not be complete, and that store and house brands of similar products may also have PPA, so check the labels of ALL cold remedies and diet products in your house.
- 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 flavor); 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 Cold 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 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.
If you have questions about drug products you can call 1-888 INFO FDA (1-888-463-6332). The FDA encourages anyone aware of a serious side effect or adverse reaction to PPA to submit a MedWatch report. You can do this from the Medwatch web site or you can call 1-800-FDA-1088.
The Center for Drug Evaluation and Research,
US Food and Drug Administration
Article Updated: 2001-10-16
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