What is Paxil?
Paxil, is an antidepressant commonly used for the treatment of depression and anxiety. Paxil is a newer type of antidepressant known as an selective serotonin re uptake inhibitor (SSRI). Selective serotonin re uptake inhibitors (SSRI's) are a class of antidepressants. They act within the brain to increase the amount of the neurotransmitter, serotonin (5-hydroxytryptamine or 5-HT), in the synaptic gap by inhibiting its re-uptake. SSRI's are frequently prescribed for anxiety disorders, obsessive-compulsive disorder, and eating disorders. Though not specifically indicated by the manufacturers, they are also sometimes prescribed to treat Irritable Bowel Syndrome.
Paxil Birth DefectsThe Food and Drug Administration recently alerted health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.
FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.
FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus. Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy. Women taking Paxil should not stop taking it without first talking with their physician.
The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.
In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.
FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.
Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.
Paxil Side Effects
behavior, roller coaster
The FDA has recently issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. This follows a report issued by Britain's Department of Health which said that evidence provided by the drug company, from nine studies based on more than 1,000 youngsters, shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.
The British regulators wrote in a statement "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks." Paxil is known as Seroxat in Great Britain. Additionally, Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug.
Recently, The British drug agency required Glaxo to remove a statement on its patient label saying that the drug was not addictive. Two years ago, a Wyoming jury awarded $6.4 million to the family of a patient taking the pill who killed his wife, daughter and granddaughter. It is estimated that almost 17 million people worldwide have been treated with Paxil.
If you or a loved one have taken Paxil and experience Paxil side effects, have had problems with Paxil withdrawal while trying to discontinue Paxil use, have lost a loved one due to a Paxil suicide, or have questions about a possible Paxil recall; contact the Paxil lawyers of Ennis & Ennis, P.A. today and find out about the possibility of a Paxil lawsuit. Call us toll-free at: 1-800-856-6405 or click for your Free Case Evaluation.
