The U. S. Food and Drug Administration issued new, stronger warnings regarding Paxil® (paroxetine hydrochloride) and its association with several serious medical conditions. The antidepressant is now required to carry black box warnings disclosing potentially fatal side effects and conditions that could result after taking the medication.  Black box warnings are the FDA's most serious warnings on medications.

Paxil® was initially approved for market in the U.S. in 1992 for the treatment of major panic disorder and obsessive compulsive disorder.  In 1999, the manufacturer sought and received approval for the use of the drug to treat social anxiety disorder, also known as social phobia.  By the early years of the new millennia, Paxil® had also been approved for the treatment of post-traumatic stress disorder (PSTD), premenstrual dysphoric disorder and generalized anxiety disorder.

Even as it sought approval to market Paxil® for all the new conditions, the manufacturer was receiving adverse event reports showing that the drug was associated with numerous catastrophic, sometimes fatal, illnesses.  Information from the FDA indicates that there were reports of users of the drug developing serious conditions, including serotonin syndrome, as well as increased risk of suicide, acute pancreatitis, toxic epidermal necrolysis, acute renal failure, pulmonary hypertension, anaphylaxis and eclampsia. 

In the first trial among the hundreds of lawsuits filed on behalf of consumers with claims of birth defects, the lawyers for a little boy who was born with a heart defect after his mother took Paxil® while pregnant presented evidence that the manufacturer knew for almost 20 years that the drug could cause birth defects.  The trial resulted in a verdict of $2.5 million for the injured child.  In 2001, a Wyoming jury rendered a $6.4 million verdict against GlaxoSmithKline in a case involving a man who shot his family and himself after taking Paxil®.

During 2004 and 2005, both the FDA and its European counterpart, the European Medicines Agency (EMEA), reviewed safety data and concluded that there was an increased risk of serious, sometimes fatal, outcomes after use of Paxil®. One of the more serious findings was the increased the risk of birth defects, particularly heart defects when women took the drug during the first three months of pregnancy. The FDA advised healthcare professionals not to prescribe Paxil® to women who were in the first three months of pregnancy or were planning pregnancy unless other treatment options were not appropriate.

As a result of the investigation, the FDA required the manufacturer to change the pregnancy category of Paxil® from C to D, a stronger warning. Category D means that studies in pregnant women had demonstrated a risk to the fetus. 

In 2006, the FDA announced another alert which affected pregnant women. Studies showed that there was an increased risk of neonatal persistent pulmonary hypertension in infants born to mothers who took SSRIs after the 20th week of pregnancy. A number of SSRIs, including Paxil®, Celexa®, Prozac® and Zoloft®, were listed by the FDA as increasing the risk for development of pulmonary hypertension.

Pulmonary hypertension is a less common type of high blood pressure which affects only the arteries in the lungs and the right side of your heart.  The illness begins when tiny arteries in your lungs, called pulmonary arteries and capillaries, become narrowed, blocked or destroyed. This makes it harder for blood to flow through your lungs, which raises pressure within the pulmonary arteries. As the pressure builds, your heart's lower right chamber (right ventricle) must work harder to pump blood through your lungs, eventually causing your heart muscle to weaken and sometimes fail completely.

Pulmonary hypertension is a serious illness that becomes progressively worse and is sometimes fatal. Although it isn't curable, treatments are available that can help lessen symptoms and improve your quality of life if you have pulmonary hypertension.

According to the Mayo Clinic, serotonin syndrome can occur when you take medications that cause high levels of the chemical serotonin to accumulate in your body. Paxil is one of the medications that can cause these extreme levels of serotonin in the body.

Serotonin is a chemical produced by your body and is needed for your nerve cells and brain to function. Nerve cells in your brain and spinalcord produce serotonin that helps regulate your attention, behavior and body temperature. Other nerve cells in your body, primarily in your intestines, also produce serotonin. In these other areas, serotonin plays a role in regulating your digestive process, blood flow and breathing.

However, too much serotonin causes problems. Severe serotonin syndrome can be fatal if it isn't treated. Serotonin syndrome usually goes away within a day of stopping the medications causing symptoms and taking drugs that block serotonin, if needed. Unfortunately for many, it does not always go away when a patient stops taking the medication.

Serotonin syndrome symptoms typically occur within several hours of taking a new drug or increasing the dose of a drug you're already taking. Signs and symptoms include:

• Agitation or restlessness
• Confusion
• Rapid heart rate
• Dilated pupils
• Loss of muscle coordination or twitching muscles
• Heavy sweating
• Diarrhea
• Headache
• Shivering
• Goose bumps

Severe serotonin syndrome can be life-threatening. Signs and symptoms of severely elevated levels of serotonin include:

• High fever
• Seizures
• Irregular heartbeat
• Unconsciousness

Even more warnings were added in 2006 which strengthened the warnings on the risk of suicidal tendencies for adult patients; especially young adults aged 18 to 24. The drug manufacturer announced that it had performed an analysis of clinical trials in adult patients with major depressive disorder (MDD) taking Paxil®. The analysis showed a higher overall frequency of suicidal behavior in adults aged 18 to 24 treated with Paxil® compared with a placebo (sugar pill). The majority of suicide attempts were in patients aged 18 to 30. This suggested that the higher frequency of suicidal tendencies seen in younger patients across psychiatric disorders may extend beyond the age of 24.

If you or someone you love were injured after taking Paxil or another selective serotonin reuptake inhibitor (SSRI), you may be entitled to financial compensation. Please fill out our online form, or call us toll free at 1-888-839-3775 to discuss your rights with one of the experienced defective drug lawyers at our firm.