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Data from clinical trials indicates that the antidepressant drug Paxil appears to increase the risk of suicide attempts in some young adults, drug maker GlaxoSmithKline warns in a letter sent to doctors.
The labeling on Paxil has been changed to reflect the finding of the Glaxo study, which analyzed data from clinical trials involving about 15,000 people, the company said. The analysis found that 11 of 3,455 people taking Paxil for treatment of depression reported an attempted suicide, compared to 1 in 1,978 of those who took a placebo, The New York Times reported.
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Most of those who reported an attempted suicide were ages 18 to 30. Overall, the analysis found no increased risk of suicidal behavior in people over 30.
Among the people taking Paxil in the clinical trials, there was one suicide, the Glaxo researchers said.
Glaxo sent the warning letters out voluntarily and said that it believes that Paxil's benefits outweigh the risk for people with depression, The Times reported.
"We are now advising doctors to monitor all patients to make sure their symptoms don't worsen," during the full course of treatment with the drug, company spokeswoman Mary Anne Rhyne said.
The U.S. Food and Drug Administration is still evaluating the data and, "we are recommending that consumers and prescribers follow current advice to carefully observe adults being treated with antidepressants for worsening of depression and for increased suicidal thinking and behavior," the agency said in a statement.
"It is essential that patients taking Paxil do not suddenly stop taking their medication," the FDA statement said.
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