About Paxil

Paxil (known generically as paroxetine) belongs to a class of popular, commonly prescribed antidepressants known as “SSRI’s” (“selective serotonin reuptake inhibitors”), marketed for the treatment of major depressive disorder and other related anxiety disorders, such as obsessive-compulsive disorder, panic disorder, social anxiety, posttraumatic stress disorder, and generalized anxiety disorder. The drug (which is produced by the pharmaceutical GlaxoSmithKline) has been in wide use since its approval by the U.S. Food and Drug Administration (FDA) in the early 1990’s—primarily because until quite recently it was considered relatively safe, less prone to causing side effects, and non-addictive.

Widespread use of Paxil and SSRIs

In the years since Paxil first hit the U.S. market, the use of antidepressants among Americans has more than tripled; in just the years between 1995 and 2002, antidepressants enjoyed a more than 48 percent jump in number of users. Paxil and its sibling SSRI’s (Prozac, Celexa, and Zoloft) account for the majority of these drugs now being heavily prescribed to treat, as one doctor puts it, symptoms of “unhappiness.”

“Doctors are now medicating unhappiness,” said Dr. Ronald Dworkin, author of the book Artificial Unhappiness: The Dark Side of the New Happy Class, in an interview with CNN. “Too many people take drugs when they really need to be making changes in their lives.”

A 2005 study by the U.S. Centers for Disease Control and Prevention found that among the 2.4 billion drugs prescribed in visits to doctors and hospitals that year, 118 million of them were for antidepressants. Strikingly, the study found that antidepressants were the most commonly prescribed drug class in the United States, ranking above medications for high blood pressure, high cholesterol, asthma or headaches.

A more recent study by the CDC found that 11 percent of Americans ages 12 and older take Paxil or other antidepressants, with the majority of these users being women.

How Paxil and SSRI’s work

Like other SSRI’s, Paxil alleviates depression by affecting the levels of naturally occurring chemical messengers (“neurotransmitters”) in the brain. These neurotransmitters, such as serotonin (the primary chemical messenger affected by SSRI’s), send signals to brain cells. SSRI’s like Paxil block the reabsorption or reuptake of serotonin (sometimes called the “happy” chemical), so that more serotonin is available to brain cells, thereby boosting mood. Most antidepressants work by changing the levels of one or more of the brain’s various neurotransmitters (serotonin, dopamine, epinephrine, etc). SSRI’s are called “selective” because they almost exclusively affect serotonin.

Paxil risks and side effects

Common side effects of Paxil may include, among others:

• Nausea
• Nervousness, agitation or restlessness
• Dizziness
• Reduced sexual desire or difficulty reaching orgasm or inability to maintain an erection (erectile dysfunction)
• Drowsiness
• Insomnia
• Weight gain or loss
• Headache
• Dry mouth
• Vomiting
• Diarrhea

Other risks associated with taking Paxil are:

• Bleeding
• Suicidal urges
• Mania and mood swings

Paxil’s links to birth defects and FDA warnings

The findings of two studies released in 2005 prompted the FDA and Paxil’s manufacturer GlaxoSmithKline to beef up their warnings regarding the use of Paxil during pregnancy. The two studies showed a higher rate of heart-related birth defects in babies born to women taking Paxil in early pregnancy than in babies born to women in the general population or to women on other antidepressants.

Whereas the risk of cardiovascular defects is about one per 100 infants normally, that risk essentially doubles for expecting mothers and their babies when exposed to Paxil, the studies found. Put another way, the FDA found that women who took Paxil during the first trimester of pregnancy were about 1.5 times more likely to have a baby with a heart defect as women on other antidepressants or women in the general population.

When occurring, heart defects in Paxil-exposed babies usually involved holes in the walls of the chambers of the heart. These defects, known in clinical terms as atrial and ventricular septal defects, range in severity from those that are minor and potentially self-correcting to those that are far more serious, require surgery and may be life-threatening.

The first study elicited an FDA alert and an updated drug label by GlaxoSmithKline. The results of the second study compelled the FDA to move Paxil from its classification as a category “C” drug in pregnancy to a category “D” drug, meaning that medical studies have shown a link between Paxil and birth defects.

Paxil litigation and settlements

The drugmaker GlaxoSmithKline has set aside more than $3 billion to settle court cases now being brought against it related to birth complications allegedly linked to Paxil-exposed pregnancies. Already class action suits have cost GlaxoSmithKline billions in patient compensation.

Lawsuits now blame Paxil for a number of serious side effects in babies. These include:

• Septal heart defects
• Pulmonary stenosis
• Pulmonary atresia
• Cleft lip or cleft palate
• Autism spectrum disorder (ASD)
• Malformed limbs
• Underdeveloped or missing parts of the skull
• Spina bifida
• Scoliosis
• Pulmonary hypertension of newborn (PPHN)

In the face of a plethora of product liability claims alleging Paxil is addictive, causes suicide and is responsible for serious birth defects, among other allegations, GlaxoSmithKline has largely denied its liability—this despite having come to numerous settlements related to the use of Paxil.

If you have good reason to believe that you or a loved one has been harmed by taking Paxil, or that Paxil is the cause of your child’s birth defects or developmental delays, you should consult a lawyer immediately about the possibility of pursuing compensation through a Paxil lawsuit.

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