GlaxoSmithKline Inc. (GSK) has issued a warning to
physicians concerning their anti-depression drug Paxil,
as it may put pregnant women at an added risk for birth
defects when compared to similar mental health
medications. If you or someone you love has suffered
side effects from Paxil, you may be entitled to
compensation. Martinez, Manglardi, Diez-Arguelles & Tejedor, P.A. is a statewide
litigation firm committed to protecting the safety of
Florida’s families. Since 1988, our firm has recovered
more than $100 million in verdicts and settlements for
our clients, in cases ranging from pharmaceutical
negligence to wrongful death.
Martinez, Manglardi, Diez-Arguelles & Tejedor, P.A. is investigating claims of
birth defects in infants born to women who took the
antidepressant Paxil while pregnant. GSK’s warning to
physicians came after a Food and Drug Administration
study examining the effects of the antidepressant in
3,581 women who took Paxil or any other antidepressant
during their first trimester. The study showed that
Paxil users had a 50 percent higher risk of delivering a
child with a birth defect compared to women on other
antidepressants.
Cardiovascular defects such as ventricular septal defect
are among the common defects found in infants who were
born to women on Paxil. However, in its letter to
physicians, GSK stated that it was inconclusive whether
children born with cardiovascular defects came as a
direct result of the mother's intake of Paxil. It did
maintain that all Paxil labels would contain a birth
defect warning in the future.
On September 27, 2005, the FDA notified healthcare
professionals of changes to the Pregnancy/PRECAUTIONS
section of the prescribing information for Paxil and
Paxil CR Controlled-Release Tablets to describe the
results of the study. The FDA letter stated that doctors
should “carefully weigh the potential risks and benefits
of using paroxetine (Paxil) therapy in women during
pregnancy and . . . discuss these findings as well as
treatment alternatives with their patients."
In addition to the risks of birth defects during
pregnancy, Paxil causes a number of side effects in
patients. Among them:
- Nausea and general malaise
- Injury
- Infection
- Diarrhea
- Constipation
- Decreased appetite
- Sleepiness
- Weakness
- Dry mouth
- Insomnia
- Dizziness
- Tremor
- Yawning
- Sweating
- Abnormal vision
- Sexual side effects
If you have experienced any of the above listed
side effects when taking Paxil, or believe that your
child suffered Paxil-related birth defects contact
an attorney immediately. At Martinez, Manglardi, Diez-Arguelles & Tejedor, P.A.,
we are on your side, and can help you make informed
decisions about your claim. We offer free
consultations in your home, at the hospital or in
our offices. There are no fees or costs unless we
win. Contact us today in
Orlando at (407) 381-4123, or in Kissimmee, (407)
846-2240.
