Paxil-Talk.com

Paxil, one of a class of drugs known as selective serotonin reuptake inhibitors (SSRIs), is one of the most popular antidepressants on the market. In fact, by 2006, it was the fifth most commonly prescribed antidepressant in the US. Unfortunately, Paxil has caused serious birth defects such as VSD / ASD and other problems in infants whose mothers used the drug during pregnancy. Paxil has also been linked to suicidal behavior in some users, especially teenagers and young adults.

Newborns whose mothers took Paxil have experienced the following problems:

• Ventral and Atrial Septal Defects: In September 2005, the FDA and GlaxoSmithKline alerted doctors about a new study on major birth defects seen in babies born to women who took the antidepressant Paxil during the first trimester of pregnancy. The alert was based on a study GlaxoSmithKline conducted of major birth defects in infants born to women who took antidepressants - including Paxil - during the first trimester of pregnancy. In the study of more than 3,500 pregnant women, 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; the most common heart malformations were septal defects, which are holes between the heart’s pumping chambers.

• Ventral Septal Defect (VSD) was the most common, and most serious, birth defect seen in this study. VSD is a hole between the right and left pumping chambers of the heart. A large VSD will gradually lead to symptoms of congestive heart failure and must be treated surgically.

• Atrial Septal Defect (ASD) is a hole in the wall between the two upper chambers of the heart. Though not as serious as VSD, this treatment may also require surgical intervention. If not treated properly, ASD can lead to serious problems in adulthood, including an increased likelihood of heart attack and stroke.

• Persistent Pulmonary Hypertension in the Newborn (PPHN): PPHN is a serious disorder in which a newborn’s arteries to the lungs remain constricted after delivery, thus limiting the amount of blood flow to the lungs and therefore the amount of oxygen in the bloodstream. About one in every 500 to 700 babies develops PPHN. It occurs most often in full-term or post-term babies after a difficult birth, or birth asphyxia (a condition that results from too little oxygen).

In July 2006, the Food & Drug Administration (FDA) warned Paxil users that it and other SSRIs had been associated with the occurrence of PPHN in children whose mothers were exposed to the drug during pregnancy. The alert was prompted by the publication of a case-control study which found that infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have PPHN than infants born to mothers who did not take antidepressants during pregnancy.

• Withdrawal: Babies born to women who took Paxil in the third trimester of pregnancy have been known to experience serious withdrawal symptoms. Complications seen in newborns suffering Paxil withdrawal include difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. In many instances, these infants require tube feeding, help with breathing and longer hospitalization.

Paxil’s side effects are not limited to birth defects. People taking Paxil have also been known to experience a number of problems, including:

• Suicide: In 2006, the FDA changed the labels of all antidepressants - including Paxil - to include an expanded warning of suicidal thoughts and behavior in patients ranging from 18-24 years of age. The new suicide warning followed an analysis of multiple trials involving 15,000 patients that revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking a placebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.
• Serotonin Syndrome: A sometimes life-threatening condition known as Serotonin Syndrome has been known to occur when SSRIs, including Paxil, are taken with migraine medications known as triptans. The disorder occurs when excess serotonin activity in the brain produces a specific spectrum of symptoms including mental status changes, overactive reflexes, muscle spasms, fever, uncoordinated movements, heavy sweating and nausea or vomiting.

Despite the serious problems it can cause, Paxil remains on the market. In fact, since its approval in 1992, more than 19.7 million prescriptions have been written for this dangerous drug.