| |
RECENT CASES |
|
| |
|
|
| |
 |
|
| |
|
|
| |
GENERAL INFORMATION |
|
| |
|
|
| |
 |
|
| |
|
|
|
| |
FDA Public Health
Advisory - Paroxetine & Infant PPH |
|
| The
Food and Drug Administration (FDA) has determined
that exposure to paroxetine in the first trimester
of pregnancy may increase the risk for congenital
malformations, particularly cardiac malformations.
At the FDA's request, the manufacturer has changed
paroxetine's pregnancy category from C to D and
added new data and recommendations to the Warnings section
of paroxetine's prescribing information. Paroxetine
is available as Paxil, Paxil CR, Pexeva, and
generic paroxetine hydrochloride. |
| The
FDA's conclusions and changes in paroxetin'’s
prescribing information are based on preliminary
analyses of two recent unpublished epidemiology
studies. |
- In a study using Swedish national registry
data, women who received paroxetine in early
pregnancy had an approximately 2-fold increased
risk for having an infant with a cardiac defect
compared to the entire national registry population
(the risk of a cardiac defect was about 2%
in paroxetine-exposed infants vs. 1% among
all registry infants).
- In a separate study using a United States
insurance claims database, infants of women
who received paroxetine in the first trimester
had a 1.5-fold increased risk for cardiac malformations
and a 1.8-fold increased risk for congenital
malformations overall compared to infants of
women who received other antidepressants in
the first trimester. The risk of a cardiac
defect was about 1.5% in paroxetine-exposed
infants vs. 1% among infants exposed to other
antidepressants.
- Most of the cardiac defects observed in these
studies were atrial or ventricular septal defects,
conditions in which the wall between the right
and left sides of the heart is not completely
developed. In general, septal defects are one
of the most common type of congenital malformations.
They range from those that are symptomatic
and may require surgery to those that are asymptomatic
and may resolve on their own. It is of note
that the data in these studies was limited
to first trimester exposures only, and there
are not currently data to address whether this
or any other risk extends to later periods
of pregnancy.
|
| The
FDA is awaiting the final results of the recent
studies and accruing additional data related
to the use of paroxetine in pregnancy in order
to better characterize the risk for congenital
malformations associated with paroxetine. In
the interim, FDA recommends the following: |
| Physicians who
are caring for women receiving paroxetine should
alert them to the potential risk to the fetus
if they plan to become pregnant or are currently
in their first trimester of pregnancy. Discontinuing
paroxetine therapy should be considered for these
patients. In individual cases, the benefits of
continuing paroxetine may outweigh the potential
risk to the fetus. If the decision is made to
discontinue paroxetine and switch to another
antidepressant or cease antidepressant therapy,
paroxetine discontinuation should be undertaken
only as directed in the prescribing information.
Paroxetine 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. |
| Women who are
pregnant, or planning a pregnancy, and
currently taking paroxetine should consult with
their physician about whether to continue taking
it. Women should not stop the drug without discussing
the best way to do that with their physician. |
| Date created: December
8, 2005 |
|
|
| Trademark
Notice: Personal Injury Lawyer America is an electronic newsletter
from Lieff Cabraser Heimann & Bernstein, LLP. Lieff Cabraser
represents clients in a wide range of cases, including personal
injury and wrongful
death lawsuits. Our personal injury attorneys
| lawyers are committed to providing the very best representation
and support possible for our clients. This website provides information
on the legal rights of the injured and the latest news on product
defects and related lawsuits. |
Lieff Cabraser
is not affiliated in any way with any trademark owner. The use of
any trademarks on this site is for product identification and information
purposes only.
About Lieff Cabraser: We have
offices in San Francisco, New York and Nashville. Our lawyers have
represented clients in personal injury, wrongful death and
rollover crashes and product defect lawsuits across America, including
residents of Alaska, Alabama, Arkansas, Arizona, California,
Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,
Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland,
Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North
Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada,
New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South
Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin,
West Virginia and Wyoming.
Among the cases our personal injury
attorneys are prosecuting are the Medtronic heart lead recall, the
AMO contact lens solution recall, the Peter Pan peanut butter recall, Guidant
pacemaker defects, SUV
rollover accidents, popcorn
workers lung injuries, and Ford
switch fires.
Disclaimer: The hiring of legal
professionals is an important decision that should not be based on
advertising alone. Please read our disclaimer. |
|
| Copyright © 2008 Lieff Cabraser Heimann & Bernstein, LLP |
|
|
|