FDA Warns Birth Defects with Paxil
16 December 2005
by Anai Rhoads
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AnaiRhoads.org - The Food and
Drug Administration (FDA) is advising that birth defect warnings should
to be added to the prescription-only antidepressant, Paxil
(paroxetine).
Researchers are investigating the link between fetal heart defects and
Paxil used by women in the first trimester of pregnancy. Early results
suggest the drug increases the risk of this and other birth defects.
The agency is waiting to hear the final results of the recent studies,
but still warn the preliminary results require immediate label changes.
Heart defects in babies whose mothers had taken Paxil in the first trimester
of pregnancy showed a 2 percent risk, compared to a 1 percent risk in the
whole population. Mothers who took other antidepressants showed a 1
percent chance of birth defects.
A majority of the heart defects reported in these studies were atrial
and ventricular septal defects (holes in the walls of the chambers of
the heart). Although some were found to be minor, others required
surgery to repair.
FDA has asked the manufacturer of Paxil, Glaxo Smith Kline (GSK), to
update the pregnancy category to a stricter warning, from C to D.
Category D are medications not recommended to pregnant women.
Paxil is approved for the treatment of depression and several other
psychiatric disorders. In May 1996, The agency approved Paxil for the
treatment of Panic Disorder. Four years later, Paxil was approved for
the treatment of Social Anxiety Disorder, and by 2001, Post Traumatic
Stress Disorder (PTSD), and Generalised Anxiety Disorder (GAD) were added
to the approved list.
Women planning to become pregnant, or are pregnant, will no longer be
advised to use Paxil. The FDA now recommends all health care
workers instead offer alternative antidepressants that have lower risk
of fetal defects.
Additional Information Provided by the FDA:
Paxil
CDER Information Sheets
Other Information About Paxil
Side Effects
GSK Sued Over Paxil
Paxil Addiction
Paxil Litigation
©2005 Anai Rhoads. Reproduction must be authorised in writing
by author only. Altering, redistributing, or selling this material is
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