Paxil Suicide

Paxil and Suicide: Did GlaxoSmithKline Disclose Suicidal Risks?

In 2003 FDA officials noticed an oddity while examining the results of a clinical trial with youngsters on Paxil. GlaxoSmithKline reported that substantially more children had shown emotional lability while on Paxil than from taking a placebo.

Emotional lability related to suicidality which is a psychiatric term for suicidal ideas or actions. The FDA was worried because although aware of the suicidal tendencies, GlaxoSmithKline had not proposed any labeling changes for Paxil to reflect the discovery. And worse – made a feeble attempt to dismiss the findings.

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The FDA launched a reexamination of trial data on antidepressants in children which caused internal problems. Before an FDA advisory panel hearing on the issue, the San Francisco Chronicle reported the internal struggle about making the data public.

In June 2004, a New York attorney sued the GlaxoSmithKline alleging that it had fraudulently withheld unfavorable data on children treated with Paxil. The company asserted that the lawsuit was unfounded and settled by agreeing to post its clinical results on the Web.

Recent studies have found that Paxil is relatively ineffective for children and suggested that children are prone to becoming suicidal during the early stages of treatment. The first effect most patients notice is a decrease in lethargy and the lack of motivation they experienced during their depression. This effect happens before the depression improves, so children may end up with enough energy and motivation to act on suicidal tendencies they may have already had.

Many people who are prescribed Paxil are suicidal to begin with. However, studies have compared suicide rates in patients using Paxil against a control group of depressed individuals not being treated with Paxil and the Paxil group was reported to be twice as likely to commit suicide.

Although GlaxoSmithKline says there is no reliable clinical evidence that the drug can cause violence or aggression, a wrongful death suit was filed June 2001 by the surviving family of a Wyoming man who killed his wife, daughter, and grandchild after two days on Paxil. During the investigation, it was reported that although Paxil is safe and effective most of the time, in a minority of cases Paxil can cause unpredictable side effects such as wild mood swings or suicidal thoughts. The jury ultimately awarded damages of $8 million against GlaxoSmithKline.

Last October the FDA finally confirmed that the suicide-related risk is real for a wide array of antidepressants (Paxil included) and required stern warnings on labels.

Contact a Paxil lawyer if you or your child has had suicidal tendencies while taking Paxil.

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