FDA Warns of Paxil Birth Defect Risks

The Food and Drug Administration (FDA) has issued an alert to physicians and patients warning of potential risks of birth defects resulting from the use Paxil, a drug prescribed for depression and several other psychiatric disorders. According to an FDA press release, early results of new studies for Paxil (paroxetine) suggest that use of the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.

"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." Click here for more details from the FDA

If you or someone you know has taken Paxil during pregnancy, please contact us immediately.

Various Paxil Tablets

Paxil (paroxetine HCI) has been linked with suicide, suicidal ideation and violence in children and teenagers. Paxil has also been associated with terrible withdrawal symptoms. Paxil is most commonly used to treat depression but is also prescribed to treat anxiety, panic, obsessive compulsive disorder, and post traumatic stress disorder.

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.

British health regulators have recently issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland and the FDA has said it will investigate the drug further.

Britain's Department of Health said the 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."

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.

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 audial hallucinations/illusions, insomnia, nausea, restlessness, "electrical shock" like phenomena/electrical surges or shocks through the head and/or body, hyper-sensitivity of the nervous system to light, sound, colours & 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 behaviour, rollercoaster emotions rapidly following up on eachother, out of character behaviour, severe malaise, general dysphoria, derealization, panic attacks.

The risk is highest when just starting or stopping the drugs and may extend to violent behaviour. In July 2001, a jury in Wyoming ordered manufacturers GlaxoSmithKline to pay $6.4 million to the relatives of Donald Schell after the 60 year old shot and killed his wife, daughter and baby granddaughter before killing himself. He had no previous history of violence and been taking Paxil for just two days.

• Addiction
• Withdrawal side-effects (Often experienced hours after a missed dose):
  • "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 audial hallucinations/illusions
  • Insomnia
  • Nausea
  • Restlessness
  • "Electrical shock" like phenomena/electrical surges or shocks through the head and/or body
  • Hyper-sensitivity of the nervous system to light, sound, colours & stressors
  • Tremors
  • Tinnitus and a vertiginous-like experience
  • Depressive thoughts
  • Suicidal thoughts
  • Homicidal thoughts
  • Extreme anger
  • Severe agitation
  • Extreme irritability
  • Ringing in ears and throbbing in head
  • Paranoia
  • Aggressiveness
  • Rollercoaster emotions rapidly following up on eachother
  • Severe malaise
  • General dysphoria
  • Derealization
  • Panic attacks.

• FDA Public Health Advisory
• Antidepressant Medication Guide

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• New York Newsday : Study ties antidepressants to suicide