FDA Advising of Risk of Birth Defects
with Paxil
Agency Requiring Updated Product Labeling
The Food and Drug Administration today is
alerting health care professionals and patients about early results of new
studies for Paxil (paroxetine) suggesting that the drug increases the risk
for birth defects, particularly heart defects, when women take it during
the first three months of pregnancy. Paxil is approved for the
treatment of depression and several other psychiatric disorders. FDA
is currently gathering additional data and waiting for the final results
of the recent studies in order to better understand the higher risk for
birth defects that has been seen with Paxil. Read More
FDA warns Paxil may increase risk of birth
defects
Pregnant women on anti-depressant encouraged
to switch to different drug
By MARC KAUFMAN and SHANKAR VEDANTAM
Washington
Post
December 14, 2005
WASHINGTON - The Food and Drug Administration has warned
pregnant women and their doctors away from the anti-depressant Paxil
because of an increased risk of heart defects in newborns.
With the warning, the agency for the first time placed a
popular anti-depressant - one in the same drug class as Prozac and Zoloft
- into its second-highest category for risk of birth defects.
The agency did not say Paxil could never be used by
pregnant women, but it did say the FDA "is advising patients that this
drug should usually not be taken during pregnancy."
The advisory is based on early results from two studies
that found that women who took Paxil in the first three months of their
pregnancies were 1 1/2 to 2 times more likely to give birth to children
with a heart defect than women who took other anti-depressants or pregnant
women overall. The studies found Paxil has a risk of birth defects that
other common anti-depressants apparently do not.
"If you're on Paxil and pregnant, our advice is to talk
to your physician and consider switching to a different drug," said Robert
Temple, the agency's associate director of medical policy.
. . .
In the studies cited by FDA, the risk of heart defects is
about 1 percent overall and rose to 1.5 percent to 2 percent in infants
born to women taking Paxil.
Though researchers have been concerned for some time
about the effect of selective serotonin reuptake inhibitors on fetuses,
the recent announcement by the FDA and Paxil manufacturer GlaxoSmithKline
is the strongest indication so far that there may be significant risks.
Since a large number of pregnant women suffer some form of depression,
decisions about whether to start or continue on anti-depressants are
increasingly common and difficult.
Adding to the complexity, an earlier study published in
the Journal of the American Medical Association found that the babies of
mothers taking anti-depressants were three times more like to suffer from
irritability, tremors and seizures in the weeks after birth.
Collecting the data
With so many concerns, support groups for pregnant women
on anti-depressants are widespread.
The advisory was based largely on a new analysis of data
from Sweden's birth registry, which collects information on pregnant women
and their offspring.
Though an initial analysis of that large database found
no correlation between birth defects and use of SSRIs, a follow-up study
found that birth defects were twice as common among Paxil users as among
women taking other anti-depressants or none at all.
Most birth defects associated with antidepressants
involve holes and malformations in the chambers of the heart. The defects
often heal on their own, and more severe cases can be surgically repaired.
Glaxo spokeswoman Gaile Renegar said the company is studying how and why
their drug might be causing these defects, adding that it remains unclear
whether there is a direct cause-and-effect relationship.
Kim Yonkers, a psychiatrist at the Yale School of
Medicine who studies the treatment of mood disorders among pregnant women,
cautioned that the database studies that the FDA had used had limitations:
Unlike controlled studies, Paxil may have been prescribed far more than
other drugs, skewing the results.
Also, she said, databases sometimes concealed unrelated
medical problems
that could alter outcomes.
"Depression is still undertreated," she said. "Pregnant
women in particular are immensely undertreated, and you worry about people
being unduly frightened."
American regulatory officials have generally been slower
to issue warnings about anti-depressants than their counterparts in other
countries, especially in the United Kingdom and Canada.
Weighing the risk, benefit
Officials in the United States have repeatedly argued
that the risks of anti-depressants need to be balanced against their
benefits. Many of the drugs, including Paxil, have been shown to be
effective against depression, anxiety and other psychiatric disorders,
especially among adults. Though no
hard studies prove anti-depressants
lower the risk of suicide, many experts
believe that to be the case and
trace a lowered suicide rate in the United States to the increased use of
anti-depressants such as Paxil.
In its warning, the FDA acknowledged this tradeoff: "In
individual cases, the benefits of continuing paroxetine may outweigh the
potential risk to the fetus."
However, FDA officials added, in general, Paxil "should
generally not be initiated in women who are in their first trimester of
pregnancy or in women who plan to become pregnant in the near future."
FDA Strengthens Warning on
Paxil
Associated Press
8 December 2005
WASHINGTON
(AP) - The Food and Drug Administration is strengthening its warning that
the antidepressant Paxil may be associated with birth defects when it is
taken during the first trimester of pregnancy.
The FDA and GlaxoSmithKline have reclassified the drug,
which goes by the generic name paroxetine, as a "Category D" drug for
pregnant women. The classification means that studies in pregnant women
have shown that the drug poses a risk to the fetus.
But the FDA said the benefits of the drug to the mother
may outweigh the risk to the fetus.
Two studies of pregnant women who were taking Paxil
during their first trimester have shown that their babies have heart
defects at a rate that is as much as twice the norm, the FDA said.
The defects are most often holes in the walls of the
chambers of the heart. Some were minor; others could require surgery.
The agency announced the strengthened warning Thursday.
It issued a previous warning in September and expanded it when information
from an additional study came in. Further studies are under way.
The FDA is advising doctors not to prescribe Paxil to
women who are in their first three months of pregnancy or to women who are
planning to become pregnant, unless there are no other options.
Women who are taking Paxil should talk to their doctor
before going off the drug, the FDA said.
Most of the heart defects reported in these studies were
atrial and ventricular septal defects, which are holes in the walls of the
chambers of the heart.
In general, these types of defects range in severity from
those that are minor and may resolve without treatment to those that cause
serious symptoms and may need to be repaired surgically. Typically, 1
percent of babies develop a defect of this nature.
GlaxoSmithKline spokeswoman Gaile Renegar said the
company is notifying doctors about the new information.
She said the company not concluded there exists a
definite, causal link between the drug and the increased incidence of
birth defects. The company has previously cited another survey of births
that it said does not note a comparable increase.
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