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Health
Officials Say They Suspected PPA's Link to Higher Stroke Risk
By
Sarah Lueck
The Wall Street
Journal, November 8, 2000
Researchers have suspected for two decades that
phenylpropanolamine, or PPA, which is found in diet drugs and nasal
decongestants, might not be safe. On Monday, the Food and Drug
Administration announced plans to ban it.
Now consumer groups and some in the medical community are
wondering what took so long. The answer: A recent study that linked PPA
and stroke was the final piece of support the agency was seeking before
taking regulatory action.
The FDA had received reports of
strokes among people who took medicines containing PPA. Based on the
reports, the agency estimated that 200 to 500 strokes a year among
individuals less than 50 years old were attributable to PPA.
While noting that strokes were rare, the FDA recommended
that consumers stop taking versions of household cold medications such as
Robitussin, Triaminic and Alka-Seltzer that contain PPA. Large drug-store
chains, such as Walgreen Co. and Rite Aid Corp., have begun
clearing drugs containing PPA from their shelves. People who take diet
medications such as Dexatrim and Acutrim are now left with no
over-the-counter alternative.
FDA officials warn that even one dose of a drug
containing PPA, which is chemically similar to amphetamines, can result in
a stroke in some individuals. Whether the medicine is a cold remedy or
appetite suppressant doesn't appear to matter. There is some indication
that taking the drug longer or at higher doses might increase the risk of
stroke, researchers said.
Researchers first raised the possibility that PPA may
raise the risk of stroke in the early 1980s when they received reports,
mostly anecdotal, of young, otherwise healthy people experiencing high
blood pressure and sometimes bleeding in the brain after taking drugs
containing PPA.
In 1982, the FDA took its first major action on PPA as it
limited the daily dose of weight-control medicines to 75 milligrams and
requested blood-pressure studies of PPA. Consumer groups began calling on
the agency to remove PPA from the market. The FDA was concerned about the
possible risk of stroke, but didn't have sufficient data to prove that
there was an association, said Robert Sherman, a biologist in the FDA
office in charge of over-the-counter drugs.
At the time, the agency had been classifying
over-the-counter medication ingredients in one of three groups: safe and
effective for consumer use; not safe and effective; or more data needed to
judge. Products cannot be marketed if they are placed in the latter two
categories.
In 1985, the agency deferred a decision on classifying
PPA nasal decongestants, later asking a group of consultants to review the
information on the drug's possible association with strokes, Dr. Sherman
said. The consultants said the data weren't sufficient to prove the
association, but that the possibility couldn't be ruled out.
In 1993, the FDA told the Consumer Healthcare Products
Association, an industry group, that it was prepared to classify PPA as
"more data needed" -- which would have required the removal from
the over-the-counter market of products containing the drug. But the
agency instead agreed to let CHPA fund a five-year study, which was
completed this year and provided the basis for the agency's proposed ban.
Watchdog groups say that is where the FDA went wrong.
Once the agency agreed to the study, it "became obligatory to wait
for the results," says Sidney Wolfe, director of Public Citizen's
Health Research Group. Leaving PPA on the market in the meantime likely
caused "a number of bouts of high blood pressure or strokes,"
said Michael Jacobson, executive director of the Center for Science in the
Public Interest.
The study was necessary "to prove there was an
association" between PPA and the negative effects, Dr. Sherman said.
"We couldn't make that conclusion from what we had."
For its part, CHPA, which paid for and helped to design
the study, disputed its central findings and continues to disagree with
the FDA's ruling that PPA increases the risk of stroke. Some drug
companies also disagree with the FDA, though many are removing products
from the market and working to replace PPA with other ingredients.
The companies selling over-the-counter appetite
suppressants such as Dexatrim, Acutrim and Permathene Mega-16 are likely
to be hardest hit by the ban, since there is no other ingredient they can
use.
"We're doing what the government says. I don't think
it's right, but I don't have a choice," said David Edell, president
of CCA Industries Inc., which sells Permathene.
Shares of Chattem Inc., which makes Dexatrim, slipped 14%, or 83
cents, to $4.98 at 4 p.m. in Nasdaq Stock Market trading. The Chattanooga,
Tenn., concern said it disagrees with the FDA's ruling, but that it will
stop shipping Dexatrim with PPA and accept returns from retailers.
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