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Paxil and Pregnancy

Women are currently being counseled not to take the anti-depressant Paxil during pregnancy or if they could become pregnant, but the warning is a recent development. Paxil is a selective serotonin reuptake inhibitor (SSRI) made by GlaxoSmithKline (GSK). It has been FDA-approved for treatment of depression, stress and anxiety disorders since 1993.

Prescribed Conditions

Paxil, a brand name for paroxetine hydrochloride, has been widely prescribed since the mid-1990s for the following conditions:

• Depression

• Panic Disorder

• Social Anxiety Disorder (SAD)

• Obsessive-Compulsive Disorder (OCD)

• Post-traumatic Stress Disorder (PTSD)

• General Anxiety Disorder

Common Side Effects

• Dry Mouth

• Constipation

• Weakness

• Yawning

• Diarrhea

• Sweating

• Infection

• Dizziness

• Tremors

• Nervousness

• Decreased Appetite

• Nausea

• Difficulty Sleeping

• Sleepiness

Serious Side Effects

• An increased risk of having suicidal thoughts or actions

• Increased risks for women who are pregnant or may become pregnant. Babies born to mothers taking Paxil late in pregnancy have developed problems such as difficulty breathing and feeding

• Mania (becoming hyperactive, excitable or elated)

• Seizures (even if Paxil is not taken in conjunction with an MAOI)

• Bleeding problems, especially if taken with aspirin, NSAIDs (non-steroidal anti-inflammatory drugs, such as ibuprofen or naproxen) or other drugs that affect bleeding

• Sexual problems including impotence (erectile dysfunction), abnormal ejaculation, difficulty in reaching orgasm or decreased libido (sexual desire)

Birth Defects

In September 2005, the FDA and GSK alerted doctors about a new study on major birth defects. The alert was based on a study done by GSK of major birth defects in infants born to mothers who took antidepressants, of which Paxil was one, during the first trimester.

The study involved more than 3,500 pregnant women and concluded that Paxil was linked to twice as many major birth defects as other antidepressants, according to the FDA. Most of the birth defects seen in the study were heart-related and the most common heart defects seen were ventricular septal defects, which are holes between the heart's two main pumping chambers.

After the alert, in December 2005, the FDA announced that it was requiring GSK to add additional warnings about Paxil-related birth defects to the drug's prescribing literature. The FDA took the action because the early results of two other studies indicated that women who took Paxil during the first trimester of pregnancy were about one and a half to two times more likely to give birth to a baby with a heart defect as women who received other antidepressants or women who took no antidepressants. The most commonly seen heart defects were atrial and ventricular septal defects. In general, the heart defects ranged in severity from those minor enough to be resolved without treatment to those serious enough to require surgical repair.

In July 2006, the FDA issued another alert announcing the results of a study conducted on the use of antidepressants during pregnancy. It concentrated on mothers of babies born with a serious medical condition called persistent pulmonary hypertension of the newborn or PPHN. The condition causes abnormal blood flow and insufficient oxygen throughout the body. Babies with PPHN can be very sick and may die. Recent studies in Sweden and the U.S. have shown that when a mother takes Paxil during pregnancy, babies are 6 times more likely to have PPHN.

There is mounting evidence showing that SSRIs dramatically increase the chances of mothers miscarrying and babies experiencing low birth weight, premature birth, erratic heartbeats and breathing problems. GSK's current literature indicates that Paxil-related complications in newborns may include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia (low blood sugar), hypotonia (low muscle tone), hypertonia (abnormal muscle tension), hyperreflexia (over-responsive reflexes), tremor, jitteriness, irritability and constant crying.

Settlements

In October 2009, GSK was ordered by a Philadelphia court to pay a $2.5 million settlement in a suit claiming Paxil caused heart defects in a 3-year-old boy. Lyam Kilker, the boy in question, was born with serious heart defects which threatened his life. According to his mother, Michelle David, it was because she took Paxil during her pregnancy. During the case, the plaintiffs' attorneys asserted that in 1993 GSK had destroyed raw data from animal studies of the drug and that in 1996, 1998 and 2000 it withheld safety reports of adverse outcomes involving mothers who took Paxil.

This is the first verdict delivered in more than 600 cases filed alleging that GSK knew that Paxil caused birth defects and hid those risks to boost its profits. More lawsuits are being initiated each month by mothers who took Paxil during pregnancy prior to the disclosure made by GSK in 2005 and who subsequently bore children with birth defects. The litigation involving Paxil will take many years and many GSK millions to fully resolve.

If you or a loved one has experienced serious side effects or health complications with Paxil, fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.