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Paxil Relater Birth Defects

Injured by Paxil?

On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.

The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.

In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk.

New Paxil Suicide Warning
Paxil (Generic: Paroxetine hci) has been linked with suicide, suicidal ideation and violence in children and teenagers. On May 12, 2006, the FDA issued a Paxil warning when results of a study became public showing that Paxil also increases suicide risk in young adults aged 18-30.  An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the pacebo.  Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.  Paxil is most commonly used to treat depression but is also prescribed to treat anxiety, panic, obsessive compulsive disorder, and post traumatic stress disorder. An estimated 17 million people worldwide have been treated with Paxil. 

In September 2004, the FDA 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.  British health regulators recently issued a warning and stated: "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks."  Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland, and the FDA continues to investigate the suicide risk associated with Paxil and other antidepressants.

Birth Defects
The FDA is strengthening its warning for the antidepressant Paxil because it may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects.  The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name Paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. Two studies of pregnant women taking Paxil during their first trimester showed that their babies have heart defects at a rate of 1.5 to 2 times the norm.  The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.

Withdrawal Symptoms
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.  Paxil has been associated with difficult withdrawal side-effects. Often these withdrawal effects are experienced just hours after a missed dose. Paxil withdrawal symptoms include a "flu-like" syndrome, anxiety, dizziness, fatigue, headache, migraine-like feelings, nerves jangling when moving eyes, continuous indigestion, neck and back pain, psychotic features such as visual and/or audio hallucinations/illusions, insomnia, nausea, restlessness, "electrical shock" phenomena/electrical surges or shocks through the head and/or body, hyper-sensitivity of the nervous system to light, sound, colors & stressors, tremors, tinnitus and a vertiginous-like experience, depressive thoughts, suicidal thoughts, homicidal thoughts, extreme anger, severe agitation, extreme irritability, "over-reacting", ringing in ears and throbbing in head, vomiting, paranoia, aggressive behavior, roller-coaster emotions, out of character behavior, severe malaise, general dysphoria, derealization and panic attacks.

In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs. 

During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.

Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.

If you or a loved one took Paxil and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.