DRUG LIABILITY - PPA / PHENYLPROPANOLAMINE
PPA/phenylpropanolamine: Recent Study Shows Ingredient in Products
Like Dexatrim and Robitussin Can Cause Fatal Strokes in Some Users
On November 6, 2000 the FDA issued a recall notice for
these drugs. According to the FDA:
"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 study and other information on phenylpropanolamine.
The Committee determined that there is an association between
PPA and hemorrhagic stroke and recommended that PPA not be considered
safe for over-the-counter use."
The FDA also issued a Public Health Advisory indicating:
Food and Drug Administration
Public Health Advisory
Subject: Safety of Phenylpropanolamine
November 6, 2000
The Food and Drug Administration (FDA) is issuing a public health
advisory concerning phenylpropanolamine hydrochloride. This drug
is widely used as a nasal decongestant (in over-the-counter and
prescription drug products) and for weight control (in over-the-counter
drug products). FDA is taking steps to remove phenylpropanolamine
from all drug products and has requested that all drug companies
discontinue marketing products containing phenylpropanolamine.
Phenylpropanolamine has been marketed for many years. A recent
study 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. Although
the risk of hemorrhagic stroke is very low, FDA recommends that
consumers not use any products that contain phenylpropanolamine.
FDA's Nonprescription Drugs Advisory Committee (NDAC) recently
discussed this study and other information on phenylpropanolamine.
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 this risk of hemorrhagic stroke is very low, FDA has
significant concerns because of the seriousness of a stroke and
the inability to predict who is at risk. 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.
In the meantime, consumers 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. Consumers can check with
their health care provider or pharmacist to see whether their
prescription cough-cold or nasal decongestant product contains
phenylpropanolamine. We advise consumers to discuss alternative
over-the-counter and prescription products with their health care
providers or pharmacists.
On October 20, 2000, major drug companies announced that
they are in the process of replacing phenylpropanolamine (PPA),
the active ingredient in many commonly used appetite suppressant
and decongestant products a day after an FDA panel recommended
banning the chemical.
An FDA panel considered banning the chemical after a recent Yale
University study showed an increased risk of strokes from bleeding
in the brain in people ages 18 to 49. The FDA estimated that between
200 and 500 hemorrhagic strokes suffered by people each year could
be linked to PPA. The Yale study found that among the people studied,
overall, PPA increased the risk of stroke by two to three times.
But for those persons taking appetite suppressants (which involve
a higher dose of PPA) the increased risk of stroke was 16-fold.
The mortality rate for a hemorrhagic stroke is 40 to 50%. Those
who are lucky enough to survive are often severely and profoundly
disabled.
According to U.S.A. Today, there are at least 22 medicines on
the market that contain PPA. They include: AcuTrim Diet Gum Appetite
Suppressant, AcuTrim Maximum Strength, Alka Seltzer Plus Cold
Medicine, Alka Seltzer Plus Children’s Cold Medicine, BC
Allergy Sinus Cold Powder, BC Sinus Cold Powder, Comtrex Flu Therapy
& Fever Relief, Contac 12-hour Cold Capsules, Contac 12-hour
Cold Caplets, Coricidin “D” Cold, Flu and Sinus, Dexatrim
Gelcaps, Dimetapp Cold and Allergy Chewable Tablets, Dimetapp
LiquiGels, Dimetapp DM Cold and Cough Elixir, Naldecon Pediatric
Drops, Permathene Mega-16, Robitussin Allergy Cough, Robitussin
CF, Tavist-D 12-hour relief, Triaminic DM Cough Relief, Triaminic
Expectorant and Triaminic Syrup.
Combined U.S. sales of appetite suppressants and cold and allergy
remedies totaled $92.93 billion for the year ending September
9, with appetite suppressants accounting for $89.4 billion of
the sales.
Your Legal Rights
If you or someone you know has experienced a stroke and had
previously taken any of the medicines containing PPA (phenylpropanolamine),
you may
have a valid legal claim.
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