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The FDA and The Center for Drug Evaluation and Research is currently reviewing reports of an increased risk of suicidal thinking and suicide attempts related to the use of the drug Paxil in children and adolescents under the age of 18 with major depressive disorder (MDD).
Based on the results of the new analyses of safety data from pediatric studies, it was found that certain possibly suicide-related behaviors, including suicidal thoughts and attempts, were more common in children receiving Paxil. The risk of these events in the study was about 3 times greater with Paxil compared to placebo. There were no deaths in these trials.
Three well-controlled clinical trials carried out in children (under 18 years of age) with MDD compared the effect of Paxil and placebo (sugar pills) and found that Paxil did not work any better than placebo in the treatment of MDD.
The FDA has not approved Paxil for the treatment of MDD or any other indication in pediatric patients. However, the FDA does not regulate the practice of medicine and physicians may use a drug in ways other than indicated on the labeling when, in their professional judgment, it is warranted in a particular case.
Paxil has not been approved for use in children under the age of 18 for any indication, but your child may have been prescribed Paxil for an off-label use. As stated above, physicians may use a drug in ways other than indicated on the labeling when, in their professional judgment, it is warranted in a particular case. If your child is taking Paxil, you should consult with your doctor before making any changes. It is very important that Paxil not be stopped abruptly since discontinuation effects may occur.
According to World Health Organization ("WHO"), Paxil has the highest incidence rate of withdrawal adverse experiences of any anti-depressant drug in the world. Studies show that 85% of people taking SSRI anti-depressants will have some type of symptom when they stop taking the drug. While the medical community has acknowledged the potential for all SSRIs to cause dependency/withdrawal syndrome, Paxil is thought to be the worst.
It is alleged that Paxil can cause some people who take it to experience serious and unexpected withdrawal reactions, including suicide. Complaints now exist that patients and physicians were unaware of the withdrawal reactions due to the manufacturers deliberate failure to warn people about these occurrences. Lawsuits have resulted because people were not made aware of Paxil's addictive, dependency, and withdrawal reactions to reduced or terminated dosages.
It is alleged that Paxil creates both physical and psychological dependency because Glaxo SmithKline has concealed information about the severe withdrawal reactions of its drug. Many patients and their physicians are confused into thinking that the withdrawal reactions are caused by something else, such as a relapse, leading to further incorrect and unnecessary medical treatment, including increased dosages of Paxil. It is alleged that doctors were not properly notified of the withdrawal symptoms and either did not taper the patients off of Paxil or re-prescribed the drug after observing withdrawal symptoms.
Symptoms include:
Other Possible Severe Paxil Withdrawal Symptoms:
fainting, scratching sounds within one's head, tingling sensations in lips and areas around them, heart palpitations and chest pain, swollen and sore eyes, fatigue, bursting headaches, lump in throat, rash, dry, flaky, and/or irritated skin, grinding teeth, difficulty with swallowing, itchiness, numbness, speech problems, trembling.
If you or a loved one took PAXIL and want to know your legal options, please contact The Monsour Law Firm, or fill out the case evaluation form for a free consultation.
Lawsuit Filed In Case Of Suicide After Paxil Use
The Chattanoogan, TN
"A lawsuit has been filed in Circuit Court against the makers of Paxil in a case in which a 20-year-old took his own life after using the drug."
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Listening to Prozac's Lawyers
CNN - Nov 15, 2005
"... Research), alleging that it had fraudulently withheld unfavorable data on youngsters treated with Paxil. Glaxo, which asserts the lawsuit was "unfounded ..."
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