A recent study shows that an ingredient in frequently used products
like Acutrim®, Dexatrim®, Robitussin®, and other commonly
used cough and cold remedies can cause fatal strokes in some users.
The Food and Drug Administration (FDA) has issued a public health
advisory concerning phenylpropanolamine (PPA). This drug was widely
used as a nasal decongestant (in over-the-counter and prescription
drug products) and for weight control (in over-the-counter drug
products). The FDA has requested that all drug companies discontinue
marketing products containing phenylpropanolamine and their manufacturers
have, in fact, voluntarily pulled these drugs from store shelves.
Phenylpropanolamine
has been marketed for many years. Scientists at Yale University's
School of Medicine recently published results of a study, which
reported that taking phenylpropanolamine increases the risk of hemorrhagic
stroke (bleeding into the brain or into tissue surrounding the brain)
in women. Men may also be at risk.
The FDA's Nonprescription
Drugs Advisory Committee (NDAC) recently discussed this study and
other information on phenylpropanolamine. The NDAC determined that
there is an association between phenylpropanolamine and hemorrhagic
stroke and recommended that phenylpropanolamine not be considered
safe for over-the-counter use.
The FDA's Nonprescription
Drugs Advisory Committee (NDAC) recently discussed this study and
other information on phenylpropanolamine. The NDAC determined that
there is an association between phenylpropanolamine and hemorrhagic
stroke and recommended that phenylpropanolamine not be considered
safe for over-the-counter use.
Although the
risk of hemorrhagic stroke is very low, the FDA recommends that
consumers not use any products that contain phenylpropanolamine.
The FDA has significant concerns because of the seriousness of a
stroke and the inability to predict who is at risk. The FDA does
not consider the conditions for which phenylpropanolamine is used
(over-the-counter or by prescription) as justifying the risk of
this serious event. Other products are available for use.
Hundreds of
over-the-counter drugs contained PPA, including the following:
- Acutrim®
Maximum Strength
- Acutrin®
16 Hour Steady Control
- Alka Seltzer®
Plus Children's Cold Medicine
- Alka Seltzer®
Plus Cold Medicine
- Appedrine®
Caplets
- BC® Allergy
Sinus Cold Powder
- BC® Sinus
Cold Powder
- Comtrex®
Flu Therapy and Fever Relief
- Contact®12
Hour
- Control Capsules
- Corocidin®
D
- DayQuil®
Allergy Relief
- Dexatrim®
Maximum Strength Caffeine-Free Caplets
- Dexatrim®
Plus Vitamins Caplet
- Dimetapp®
- Naldecon®
Pediatric Drops
- Permathene®
Mega-16
- Robitussin®
CF
- Tavist®-D
- Triaminic®
Consumers can
also 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. Consumers can check with their health care provider
or pharmacist to see whether their prescription cough-cold or nasal
decongestant product contains phenylpropanolamine. Consumers are
advised to discuss alternative over-the-counter and prescription
products with their health care providers or pharmacists.
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