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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