Paxil Questions
Q: What is Paxil?
A: Paxil, made and sold by GlaxoSmithKline, was approved by the Food and Drug Administration in 1992. This drug is meant to help relieve the symptoms of depression, anxiety and obsessive-compulsive disorders. Paxil is among a group of drugs known as selective serotonin reuptake inhibitors (SSRIs), which increase the level of serotonin in a person’s brain. Paxil is marketed as Seroxat in Europe.
Most babies with Paxil birth defects—such as heart defects, cleft lip or palate and problems with the digestive system—require surgery.
Q: Are there any side effects associated with Paxil?
A: Yes. Paxil side effects include weakness, dry mouth, constipation, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite and sexual problems.
Q: Do people tend to gain weight while on Paxil?
A: Many patients have observed that they gained 20 to 40 pounds while on the drug and could not get rid of it until they stopped taking Paxil.
Q: What allegations have been made regarding GSK and Paxil?
A: A lawsuit filed in New York contends that GSK suppressed four studies which demonstrated Paxil’s ineffectiveness in treating children and adolescents, and suggested a possible increase of suicidal thoughts and behavior. The lawsuit refers to a 1999 document showing that the company intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.”
Q: Does Paxil cause birth defects?
A: Some studies suggest that birth defects are more common in babies whose mothers took Paxil in the first trimester of pregnancy. A recent study followed a group of 958 women who took Paxil early in their pregnancies. The results suggest that about 4 in 100 babies whose mothers take Paxil in early pregnancy will be born with a birth defect, as compared with 3 in 100 babies born to women who do not take Paxil. About 2 in 100 babies whose mothers take Paxil in early pregnancy will be born with a heart defect, as compared with 1 in 100 babies born to women who do not take Paxil.
Q: What sort of Paxil birth defects did the babies have?
A: They mainly had heart defects, such as a hole in the heart (known as a “ventricular septal defect”). The study also found problems such as a cleft lip or palate and problems with the digestive system. In most cases, surgery is needed to repair these Paxil birth defects.
Q: If I wish to stop taking Paxil, can I do so immediately?
A: It’s better not to stop taking Paxil suddenly unless you have medical guidance. Otherwise, you may get withdrawal symptoms which include nausea, dizziness, headaches, sweating, problems sleeping and a resumption of depression or anxiety.
Q: What has the FDA said about Paxil?
A: It compelled GSK to add a “black-box” warning to Paxil with information describing the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressants. In May 2006, GSK and the FDA announced labeling changes pertaining to younger adults. Two months later, the FDA issued two alerts related to Paxil. The first FDA alert was about the use of antidepressants such as Paxil during pregnancy in mothers of babies born with persistent pulmonary hypertension of the newborn (PPHN). The second FDA alert was about serotonin syndrome, which can occur when SSRIs (such as Paxil) and medicines used to treat migraine headaches are taken together.
Q: What should I do if I think I have been injured as a result of taking Paxil?
A: If you or a loved one have experienced any dangerous symptoms or unusual medical conditions related to Paxil use, you should first contact a doctor. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Paxil use. Many Paxil lawsuits have been filed in the last two years.
