April 1, 2011
Paxil Could Cause More Suicidal Thoughts For Depressed
Drug maker GlaxoSmithKline released a new report detailing that its antidepressant Paxil could potentially make people with major depression more likely to become suicidal.
But in clinical trials, the company found that attempted suicide rates were relatively low -- 0.34 percent for those using Paxil vs. 0.05 percent for those taking a placebo pill.The report also states that the findings couldn't rule out that the difference was due to chance.
"The scientific evidence does not establish that paroxetine," the active ingredient in Paxil, "causes suicide, suicide attempts, self-harm or suicidal thinking," Sarah Alspach, a spokeswoman for the drug company, told Reuters Health by email.
"Nonetheless, all patients who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior," said Alspach.
The link between the risk of suicide and antidepressants has been a touchy subject for regulators and drug companies for some time. The current data was published in 2006 on GlaxoSmithKline's website in response to growing concern.
The US Food and Drug Administration (FDA) issued a warning in 2004 that minors taking antidepressants might have an increased risk of suicidal tendencies. The agency found that 4 percent of children taking antidepressants in clinical trials had thought about suicide, self mutilation, or actually have attempted suicide.
The FDA found that, by comparison, only 2 percent of children using a placebo either had those thoughts or attempted suicide.
The FDA extended its warnings in 2006 to include young adults up to age 25. All antidepressants are required to carry a "black box" label warning of the possible likelihood of suicidal thoughts and behaviors when using the medication.
The study showed a less-than clear picture of how antidepressants affect adults' thoughts and behaviors.
GSK's report was based on 57 clinical trials of Paxil used for a variety of psychiatric illnesses, involving about 15,000 patients. The study found that, overall, the drug did not appear to show an increase in suicidal thoughts and behavior.
It did, however, show a difference in 18- to 24-year-olds. The authors said for that age group, 2.58 percent of Paxil users thought about or attempted suicide, compared to 1.29 percent of those using placebo treatment.
Again, those findings could have been due to chance because of the low rate of suicidal thoughts and behaviors.
Data from 19 trials that only included people with major depression showed that among 3,455 Paxil users, 0.34 percent attempted suicide, compared to 0.05 percent of 1,978 people who received the placebo.
Despite the disconcerting findings, the report, which is published in the Journal of Clinical Psychiatry, notes that Paxil was effective overall at treating symptoms of mental illness.
"Paxil has proven efficacy and has helped many people battling mental illness lead more productive, happier lives," Alspach told Reuters Health.
The Centers for Disease Control and Prevention (CDC) says that antidepressants are among the most commonly prescribed classes of drugs in the US.
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