.
.
.
.
.
.
.
.
.

May 13, (foodconsumer.org) - Paxil, a popular antidepressant, and its controlled-release version, Paxil CR have been linked to an increased risk of suicidal tendencies in young adults, the Food and Drug Administration (FDA) and the drug's maker GlaxoSmithKline warned doctors Friday.

The warning on Paxil, chemically known as paroxetincame, as a meta-analysis of clinical trials has linked the antidepressants to elevated suicidal behavior in adults, particularly those ages 18 to 30.

In a letter to healthcare professionals, Glaxo warned that patients on Paxil need careful monitoring, "It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated," the company's letter said.

However, the letter adds that the company "continues to believe that the overall risk: benefit of paroxetine (Paxil) in the treatment of adult patients with MDD [major depressive disorder] and other non-depressive psychiatric disorders remains positive." Glaxo's letter is posted on the FDA website.

The letter cites a meta-analysis conducted on 9,000 patients who were taking Paxil and almost 6,000 others on a placebo. Participants in these trials had psychiatric disorders including MDD, other depression, and nondepression disorders. The analysis showed the presence of increased suicidal tendencies in younger patients taking Paxil as compared with those on a placebo.

Suicide tendencies were not present in older adults, but GSK said that there was no statistic significance, meaning it may have been due to chance. A second analysis focused on major depressive disorder in adults of all ages. GlaxoSmithKline reported that there was a higher frequency of suicidal behavior in those taking Paxil than in those patients taking a placebo.

Glaxo noted that there were 11 cases of suicidal behavior among 3,455 patients taking Paxil as compared to 1 case out of 1,978 taking placebo. It added that 0.32 percent of patients taking Paxil showed suicidal behavior as compared to 0.05 percent of those taking placebo.

"All of the reported events of suicidal behavior in the adult patients with MDD were nonfatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30," GlaxoSmithKline's letter says. Additionally most patients who attempted suicide when on Paxil "had an identified social stressor at the time of the event."

The letter concludes that "it is difficult to conclude a causal relationship between paroxetine and suicidality due to the small incidence and absolute number of events, the retrospective nature of this meta-analysis, and potential for confounding by the fact that the events of interest are a symptom of the psychiatric illnesses themselves."

The company said that it had changed the label for Paxil to reflect these new findings. The FDA had ordered all drug companies that produce similar antidepressants to place a strong warning on antidepressant labels in October 2004 following the findings of increased suicidal behavior in children and adolescents.

Even in the studies on children and adolescents, there were only episodes of suicidal thinking and no fatalities were reported. Reacting to the current study, the FDA said that it was still evaluating the data, but "we are recommending that consumers and prescribers follow current advice to carefully observe adults being treated with antidepressants for worsening of depression and for an increased thinking of suicide. It is essential that patients taking Paxil do not suddenly stop taking their medication."

Earlier studies however have time and again highlighted the risks of antidepressants especially on the suicide attempts. A large review of the drugs reported in the British Medical Journal last year had found that people taking Paxil and Prozac admitted to attempting suicide more often. Antidepressants have already been banned by British regulators for use in children.

The current analysis had not convinced experts who say that the studies have proved inconclusive since they were not specifically designed to assess the suicide risk of Paxil.

"The new findings are not going to change my practice a lot, but I say, yes, they provide a reason to do even more careful monitoring of people on the medication," said Dr. George Simpson, a professor in psychiatry and behavioral sciences at the Keck School of Medicine at the University of Southern California. However, he agreed that a better system of monitoring needs to be in place to evaluate the antidepressants such as Paxil already on the market. "The current system of postmarketing surveillance is lousy."

Paxil was involved in a case where a 60-year-old man called Donald Schell, had killed his wife, daughter, granddaughter and then himself three hours after taking two Paxils that were given to him as samples. The jury in Wyoming had awarded the surviving members of his family $6.4 million. Glaxo later settled the case.

"Right now, the warning applies only to kids," said Kelly Posner, an assistant professor in the department of child psychiatry at Columbia University Medical Center in New York. "Later on in the year, whenever the FDA is ready, a large pooled analysis with all the companies and all the drugs will see if they find similar things in the adult data."

Paxil is a popular antidepressant drug although it has no longer had market exclusivity. In April, Glaxo had reported that sales of the drug in the first quarter had fetched $304 million.

© 2004-2005 by foodconsumer.org unless otherwise specified

Top of Page