See: Paxil CR Dear Doctor / Healthcare Professional Letter September 2005

PAXIL Warnings

PRECAUTIONS in Dear Doctor Letter - September 2005

Pregnancy: Teratogenic Effects: Pregnancy Category C.

There are no adequate and well controlled studies in pregnant women. A recent
retrospective epidemiological study of 3,581 pregnant women exposed to
paroxetine or other antidepressants during the 1st trimester suggested an increased
risk of overall major congenital malformations for paroxetine compared to other
antidepressants (OR 2.20; 95% confidence interval 1.34-3.63). There was also an
increased risk for cardiovascular malformations for paroxetine compared to other
antidepressants (OR 2.08; 95% confidence interval 1.03-4.23); 10 out of 14 infants
with cardiovascular malformations had ventricular septal defects. A separate study
based on the Swedish Medical Birth Registry evaluated 4,291 infants exposed to
SSRIs in early pregnancy. This study reported no increased risk for overall major
malformations in 708 infants born to women with paroxetine exposure in early
pregnancy.

Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6
mg/kg/day in rabbits administered during organogenesis. These doses are
equivalent to 9.7 (rat) and 2.2 (rabbit) times the maximum recommended human
dose (MRHD) for major depressive disorder, social anxiety disorder, GAD, and
PTSD (50 mg) and 8.1 (rat) and 1.9 (rabbit) times the MRHD for OCD, on an
mg/m2 basis. These studies have revealed no evidence of teratogenic effects.
However, in rats, there was an increase in pup deaths during the first 4 days of
lactation when dosing occurred during the last trimester of gestation and continued
throughout lactation. This effect occurred at a dose of 1 mg/kg/day or 0.19 times
(mg/m2) the MRHD for major depressive disorder, social anxiety disorder, GAD,
and PTSD; and at 0.16 times (mg/m2) the MRHD for OCD. The no-effect dose for
rat pup mortality was not determined. The cause of these deaths is not known.
Paroxetine should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.

See: Paxil CR Dear Doctor / Healthcare Professional Letter September 2005

"GlaxoSmithKline PLC faces new questions about whether it deliberately misrepresented data on suicide risk for its antidepressant Paxil when it applied for the drug's approval to the U.S. Food and Drug Administration at an advisory committee meeting in 1991, a charge the company has denied.

A study by a Harvard psychiatry instructor, underwritten by plaintiffs' lawyers and previously kept under seal by a court order, says that Glaxo 'improperly' counted patients taking placebos during clinical studies. From 1989 through 1991, Glaxo then submitted information to the FDA that indicated no major difference in risk of suicidal behavior, or suicidality, as doctors call it, between patients who took Paxil and those who took a placebo. However, Glaxo's counting minimized the differences between suicidality rates in the Paxil and placebo groups, according to the report. For instance, the company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil."

June 19, 2008

Paxil & Antidepressants Causing Atrial and Septal Heart Defects

Medical studies have recently concluded that Paxil and other antidepressants may cause cardiovascular defects in babies' hearts. The FDA has alerted pregnant women who take Paxil (paroxetine) during the first trimester of pregnancy that such Paxil usage may increase the risk of their babies being born with holes in the heart. These Paxil heart defects include atrial and ventricular septal defects. With Paxil use, the chances of such heart defects almost doubles.

In fact, according to the FDA, "The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. "

Paxil Birth Defects

If you baby has been born with serious Paxil lung damage or Paxil heart damage, other serious Paxil birth defects or Paxil Lung damage / PPHN, then call our law firm to discuss your legal options. Free Consultation. Call 1-800-883-9858

The tetralogy of Fallot (TOF) is a congenital heart defect which classically has four anatomical components. Tetralogy of Fallot is the most common cyanotic heart defect and the most common cause of blue baby syndrome.

Children with tetralogy of Fallots may develop "tet spells". The precise mechanism of these episodes is in doubt, but presumably results from an increase in resistance to blood flow to the lungs with increased preferential flow of desaturated blood to the body

Tetralogy of Fallot results in low oxygenation of blood due to mixing of oxygenated and deoxygenated blood in the left ventricle through the VSD and preferential flow of both oxygenated and deoxygenated blood from the ventricles through the aorta because of obstruction to flow through the pulmonary valve. This condition is known as a right left shunt.

Paxil Usage During Pregnancy?

Has any Doctor ever told you that your baby's Tetralogy of Fallot may have been caused by taking Paxil or any other anti-depressant during pregnancy? Did you know that Paxil use during pregnancy may increase the risk for heart valve defects? If you have questions about any birth defect or heart valve abnormality, breathing problem or other condition, please call us to discuss. Call Toll Free 1-800-883-9858

Premature Baby- Did you take Paxil during Pregnancy?

Paxil and similar antidepressants have been linked to an increased risk of premature birth according to a new SSRI study, presented at the annual meeting of the American Psychiatric Association, involved about 200 pregnant women. About half of them suffered from depression, and half of those women took SSRIs throughout pregnancy. About 23 percent of those who took SSRIs throughout pregnancy gave birth to preterm babies. Only 6 percent of women who did not have depression and didn't take SSRIs had preterm babies.

Preterm Births More Likely with Paxil Usage

Paxil can cause premature births. This is just one of the many risks posed by Paxil and the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Paxil is also shown to increase the likelihood of heart valve defects, septal and atrial valve defects, lung damage and otherbreathing difficulties in the babies born of women taking Paxil and other SSRIs early in pregnancy.

Paxil Birth Defects

If you baby has been born with serious Paxil lung damage or Paxil heart damage, other serious Paxil birth defects or Paxil Lung damage / PPHN, then call our law firm to discuss your legal options. Free Consultation. Call 1-800-883-9858

According to a recent article in the New England Journal of Medicine, persistent pulmonary hypertension of the newborn (PPHN) is associated with substantial infant mortality and morbidity. A previous cohort study suggested a possible association between maternal use of the selective serotonin-reuptake inhibitor (SSRI) fluoxetine late in the third trimester of pregnancy and the risk of PPHN in the infant. We performed a case??"control study to assess whether PPHN is associated with exposure to SSRIs during late pregnancy.

Between 1998 and 2003, we enrolled 377 women whose infants had PPHN and 836 matched control women and their infants. Maternal interviews were conducted by nurses, who were blinded to the study hypothesis, regarding medication use in pregnancy and potential confounders, including demographic variables and health history.

Fourteen infants with PPHN had been exposed to an SSRI after the completion of the 20th week of gestation, as compared with six control infants (adjusted odds ratio, 6.1; 95 percent confidence interval, 2.2 to 16.8). In contrast, neither the use of SSRIs before the 20th week of gestation nor the use of non-SSRI antidepressant drugs at any time during pregnancy was associated with an increased risk of PPHN.

These data support an association between the maternal use of SSRIs in late pregnancy and PPHN in the offspring; further study of this association is warranted. These findings should be taken into account in decisions as to whether to continue the use of SSRIs during pregnancy.

Paxil Birth Injury Lawsuit

If you have any questions about filing a potential Paxil lawsuit for any injury or birth defect that you believe was caused to your child due to use of Paxil during pregnancy, then call and speak to a Paxil Lawyer at 1-800-883-9858

Serious Paxil Side Effects

According to Doctors and Health Care Providers, if you experience nausea, vomiting, drowsiness, dizziness, diarrhea, trouble sleeping, yawning, constipation, or dry mouth during or after taking Paxil, then you should notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: loss of appetite, unusual or severe mental/mood changes, increased sweating/flushing, unusual fatigue, uncontrolled movements (tremor), decreased interest in sex, changes in sexual ability. Tell your doctor immediately if any of these unlikely but serious side effects occur: black stools, blurred vision, change in amount of urine, "coffee ground" vomit, easy bruising/bleeding.

Further, tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, irregular heartbeat, muscle pain, trouble swallowing, unusual swelling, seizures, tingling or numbness of the hands/feet. Paroxetine may infrequently cause suicidal thoughts or self-harm urges in children or teenagers up to 18 years of age. Tell the doctor immediately should this occur (see Uses section). Males: In the very unlikely event you have a painful, prolonged erection, stop using this drug and seek immediate medical attention or permanent problems could occur. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist

Paxil Birth Defects

If you baby has been born with serious Paxil lung damage or Paxil heart damage, other serious Paxil birth defects or Paxil Lung damage / PPHN, then call our law firm to discuss your legal options. Free Consultation. Call 1-800-883-9858