date: 5/17/2006
Safety alert: Young adults taking Paxil warned of increased suicide risk
Adult patients, especially younger adults ages 18 to 30, have an increased risk of suicidal behavior when taking the antidepressant Paxil (paroxetine). They should be watched closely for symptoms such as agitation, panic attacks, irritability, and hostility, which may be the first hints of emerging suicidality.
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In 2005 the Food and Drug Administration alerted the public to newly published studies suggesting that adults on antidepressants might have an increased risk of suicidal behavior. The agency announced plans to re-analyze the results of clinical trials conducted as part of the drug approval process to see if those studies, too, showed increased risk of suicidal behavior, including not only actual suicides but also failed suicide attempts or thinking or talking about suicide.
On May 12, 2006, GlaxoSmithKline (the maker of Paxil) said that its own re-analysis of clinical trials involving nearly 15,000 adults did indeed turn up evidence that patients ages 18 to 24 who were given Paxil had more than twice the incidence of suicidal behavior as patients who received dummy pills. The incidence was still relatively low--2.2 percent--and not statistically significant, but the finding prompted the company to strengthen warnings on the drug's label. The suicidal behavior occurred even in patients who were being treated for conditions other than depression, which itself makes people more prone to think about or attempt suicide.
The analysis also found that suicidality rose, though not as much, in adults being treated for major depression only, especially among those under the age of 30.
In a letter to health-care professionals, GlaxoSmithKline advised that it is "important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated."
On May 12, 2006, GlaxoSmithKline (the maker of Paxil) said that its own re-analysis of clinical trials involving nearly 15,000 adults did indeed turn up evidence that patients ages 18 to 24 who were given Paxil had more than twice the incidence of suicidal behavior as patients who received dummy pills. The incidence was still relatively low--2.2 percent--and not statistically significant, but the finding prompted the company to strengthen warnings on the drug's label. The suicidal behavior occurred even in patients who were being treated for conditions other than depression, which itself makes people more prone to think about or attempt suicide.
The analysis also found that suicidality rose, though not as much, in adults being treated for major depression only, especially among those under the age of 30.
In a letter to health-care professionals, GlaxoSmithKline advised that it is "important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated."
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