Paxil may raise suicide risk

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http://www.msnbc.msn.com/id/12757835/print/1/displaymode/1098/

 

MSNBC.com

 

FDA: Antidepressant may raise suicide risk

 

Young adults taking Paxil should be monitored by their doctors, FDA

warns

 

The Associated Press

Updated: 3:42 p.m. ET May 12, 2006

 

WASHINGTON - The antidepressant Paxil may raise the risk of suicidal

behavior in young adults, GlaxoSmithKline and the Food and Drug

Administration warned Friday in a letter to doctors.

 

The warning letter was accompanied by changes to the labeling of both

Paxil and Paxil CR, a controlled-release version of the drug, also

called paroxetine.

 

A recent analysis of clinical trial data on nearly 15,000 patients

treated with both Paxil and dummy pills revealed a higher frequency of

suicidal behavior in young adults treated with the drug, according to

the letter.

 

The FDA reported that there were 11 suicide attempts †" none

resulting in death †" among the patients given Paxil in the trials.

Just one of the dummy pill patients attempted suicide.

 

Given that small number, the results “should be interpreted with

caution,†the FDA said. Eight of the 11 attempts were made by

patients between the ages of 18 and 30. All trial patients suffered from

psychiatric disorders, including major depression.

 

GlaxoSmithKline released its findings following an FDA request that

antidepressant manufacturers examine their clinical trial data for any

links between the drugs and suicide in adults, company spokeswoman Mary

Anne Rhyne said.

 

“At some point, the FDA is going to say what their analysis

shows across the category,†Rhyne said, adding of her

company’s own analysis: “We felt like this was

information we wanted to share with physicians.â€

 

In the letter to doctors, Dr. John E. Kraus, the company’s

director of clinical development for clinical psychiatry in North

America, said GlaxoSmithKline PLC continues to believe the

drug’s benefits outweigh its risks.

 

The FDA stressed that all patients, especially young adults and those

who are improving, should be carefully monitored when treated with

Paxil.

 

In 2004, the FDA ordered strong warnings about the pediatric risk of

suicidal tendencies put on antidepressant labels, and began analyzing

whether adults face a similar risk.

 

All antidepressants now carry warnings on their labels cautioning

patients and doctors of the risk of suicidal behavior.