Understanding Paxil Birth Defects

Ann Blake-Tracy says:

Your comment is awaiting moderation.

After two decades of tracking mothers and babies exposed to SSRI
antidepressants during pregnancy I shutter to ever see a mother take one of
these drugs. If those adverse effects listed in this article are not bad enough
to consider exposing a baby to, we have yet to witness the full effects of these
drugs upon offspring. These babies brains will not be fully developed until they
are in their 20’s. The full negative effects upon that developing brain will not
be known until then. Knowing what I know after 20 years of researching these
drugs and tracking patients who have taken them, I DO NOT WANT TO SEE WHAT IS
COMING!!

Ann Blake-Tracy, Executive Director,
International Coalition for Drug
Awareness
http://www.drugawareness.org & http://www.ssristories.drugawareness.org

Understanding Paxil Birth Defects

In December 2005, GlaxoSmithKline (GSK) posted its Paxil findings on its
website regarding pregnant women taking antidepressants. In this announcement,
GSK noted that it was revising its pregnancy precaution category from C to D.
This revision was based on recent studies that indicated positive evidence of
human fetal risk. In addition, GSK was placing this information in the WARNINGS
section of the Paxil label.
The FDA then advised pregnant women to switch from Paxil to another SSRI
drug, such as Prozac or Zoloft. This warning was based on the results of an
analysis of Sweden’s birth registry that showed women who took Paxil were 1.5 to
2 times more likely to give birth to a baby with heart defects than women who
took other selective serotonin reuptake inhibitors (SSRIs) or no antidepressant
at all.
Studies also showed that complications were reported for babies born to
mothers who had taken antidepressants such as Paxil in the third month of
pregnancy. Such complications included breathing difficulties, turning blue,
seizures, changing body temperature, feeding problems, vomiting, low blood
sugar, stiffness, tremor, irritability or constant crying. In other words, just
like adults, newborn babies of mothers who have taken Paxil while pregnant,
experience similar withdrawal symptoms. Because of this, tube feeding, help with
breathing and longer hospitalization may be needed. Premature births in pregnant
women exposed to SSRIs such as Paxil have also been reported.
Based on such reports obstetricians went so far as to recommend that
women avoid Paxil and reconsider using any SSRI antidepressant during pregnancy.
Still, other physicians maintain that the benefits of mothers getting treatment
for their depression outweigh the risks to the fetus.
The most common birth defects caused by antidepressants have been found
to be holes or other malformations in the chambers of the heart. Often the

defects heal on their own, but more severe cases need surgical procedures. GSK
is investigating how Paxil could be causing such defects.
In addition, antidepressant drugs are known to imbalance blood sugar
metabolism thereby worsening gestational diabetes. However, it is doubtful that
this is explained to expectant mothers who are given such drugs.
Medical professionals in women’s mental health point out that it is
important to aptly gauge the timing of medications prescribed for women who are
pregnant. Paxil is currently one of the most popular antidepressants in the
world, and roughly 25 percent of its users are women of childbearing age —
between 18 and 45.

Nick Johnson serves as lead counsel with Johnson Law Group, with principal
offices located in Houston, Texas. Johnson represents plaintiffs with injury
cases involving Defective Drugs. Contact Nick Johnson at 1-888-311-5522 or visit
http://www.johnsonlawgroup.com

316 total views, no views today

PAXIL: BIRTH DEFECTS – TEST CASE FOR OVER 600 MORE CASES – USA

First two paragraphs read:  “GlaxoSmithKline P.L.C., the
world’s second-biggest drugmaker, begins a trial in Philadelphia next week in
what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth defects.”

“Patients and their parents say internal company documents
show Glaxo failed to warn consumers about the risks of Paxil until forced
to do so in 2005 by the Food and Drug Administration.
In the trial set
to start Monday, Michelle David blames the drug for causing life-threatening
heart defects in her son, Lyam Kilker, now age 3.”

Glaxo trial opens here Monday in what could be Paxil test case

By Sophia Pearson and Margaret Cronin Fisk

Bloomberg
News
GlaxoSmithKline P.L.C., the world’s second-biggest drugmaker, begins a
trial in Philadelphia next week in what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth
defects.

Patients and their parents say internal company documents show
Glaxo failed to warn consumers about the risks of Paxil until forced to do so in
2005 by the Food and Drug Administration. In the trial set to start Monday,
Michelle David blames the drug for causing life-threatening heart defects in her
son, Lyam Kilker, now age 3.

The company, based in London and with major
operations in Philadelphia and its suburbs, faces two more such trials each
month from October through January in state court in Philadelphia.

“The
early cases set the parameters for any global settlement negotiations,” said
David Logan, dean and professor of law at Roger Williams University in Bristol,
R.I.

Paxil, approved by the FDA in 1992, generated about $942 million in
sales last year, 2.1 percent of the total for the company.

Glaxo has
settled other Paxil-related cases, including a suit brought by the New York
Attorney General’s Office accusing the company of withholding safety data about
the antidepressant.

The drugmaker isn’t liable for Lyam Kilker’s heart

defects, and it acted responsibly in testing Paxil and updating safety
information, Kevin Colgan, a Glaxo spokesman, said in an e-mail.

“The
scientific evidence simply does not establish that exposure to Paxil during
pregnancy caused Lyam Kilker’s condition,” Colgan said. “Very unfortunately,
birth defects occur in 3 to 5 percent of all live births, whether or not the
mother was taking medication during pregnancy.”

The FDA said in an alert
to doctors on Dec. 8, 2005, that preliminary studies suggested Paxil might
contribute to heart defects in infants when taken in the first three months of
pregnancy. The government asked the company to update the label enclosed with
the medicine, changing its birth-defect warning.

The FDA’s action does
not prove any connection between Paxil use and birth defects, Glaxo said in
court filings in July.

“GlaxoSmithKline will show it acted properly and
responsibly in conducting its clinical trial program for Paxil, in marketing the
medicine, in monitoring its safety once it was approved for use and in updating
pregnancy information in the medicine’s label as new information became
available,” Glaxo’s Colgan said.

Lawyers for patients say Glaxo
documents show the company had known since 1980 that Paxil could raise the risk
of birth defects.

Buzz
up!
Buzz this story.

320 total views, no views today