Dave, Here's an interesting update on isotretinoin:
W A S H I N G T O N, Feb. 25 - Makers of a popular
prescription acne medication said today they would
add a warning to the label telling doctors to look
out for depression and suicidal tendencies in their
patients.
Hoffmann-La Roche said it
had received reports of
depression and suicide in
teen-agers taking Accutane,
its prescription product for
severe acne.
The Nutley, New
Jersey-based company would
not say how many reports it
had received but said it was worried enough to strengthen
label warnings that already describe the risk.
"The people that treat people with acne should be more
attentive to symptoms of depression, psychosis ... and
suicide," Roche spokeswoman Kellie McLaughlin said.
She said there was no evidence the drug actually caused
these symptoms.
"It's based on some of the MedWatch reports that FDA
and Hoffman have received," she said. MedWatch is a
system set up by the FDA with drug companies to track
reactions to drugs that are on the market.
May Just Be Depression
"We looked at it and we thought this was a population at
risk," she added. "Teen-agers have a higher incidence of
depression than most. It's very hard to tease out exactly what
is causing the depression."
McLaughlin said Roche had invited experts to examine the
reports, but they were unable to find evidence of anything the
drug might be doing to cause depression.
The label, written up with the approval of the U.S. Food
and Drug Adminstration (FDA), says no mechanism of action
has been established. This means the drug might not be the
cause, and taking a depressed teenager off Accutane might
not solve the problem.
"Discontinuation of Accutane therapy my be insufficient;
further evaluation may be necessary," it will say.
McLaughlin said some of the reportedly depressed
patients had stopped Accutane before their symptoms were
reported. "In many cases they had no taken Accutane for a
year and we know that Accutane leaves your system after
seven days," she said.
Lower Rate for Accutane Users
McLaughlin said the average background rate of suicide is
about 0.05 percent of the population among teenagers. The
suicide rate among those taking Accutane is "far, far, far
below that" but she would not say what the rate was.
Eight million people have taken Accutane, known
generically as isotretinoin. Approved by the FDA in 1982, it
is also sold as Roaccutane.
Accutane is prescribed for "severe, reclacitrant acne." "It's
for the very worst form of acne and recalcitrant means that
nothing else has worked," McLaughlin said.
"I like to describe the accutane patient as the kid we all
remember as having the worst acne in the school-the face
that breaks your heart." Teenagers, already at a higher risk of
depression, might understandably be upset by such a
problem, she said.
Accutane can cause severe birth defects and must not be
used by women who might become pregnant.
It is a vitamin A derivative that decreases the production
of oil. Overproduction of oil, which converts to a waxy
substance in the glands, is one cause of acne. This waxy
build-up irritates the skin, which can become infected. |
