Add antidepressant warning labels for young adults: U.S. panel

Antidepressant drugs should be labelled to warn that their use may increase the risk of suicidal thoughts and behaviour in people up to age 24, a U.S. government advisory panel said Wednesday.

The information should be added to current "black box" warnings that say taking the drugs may increase risks in children and teens, said the panel of outside experts, which the U.S. Food and Drug Administration called on for advice on the issue.

The FDAput forth its plan to update the drug labels at the meeting, saying thechangeswould include a recommendation for careful monitoring, especially when patients are beginning treatment.

Public reaction was split, with some saying the changes were overdue and others arguing they could keep drugs from those who need them.

In emotional testimony illustrated at times by slides of family photos, relatives of suicide victims pleaded for the new warnings. Suzanne Gonzalez, shouting and in tears, goaded the panel to action, telling the experts that her 40-year-old husband who had been taking Paxil shot himself.

"I wake up every morning thinking, 'Oh my God, he's dead. He is freaking dead.' Do you wake up and think, 'How many people are going to die today because I am doing nothing?"' Gonzalez asked.

Questions raised

Still, mental health experts worry that additional warnings could curtail use of the drugs and ultimately do more harm than good.

Dr. John Mann, a Columbia University psychiatrist, suggested simply replacing the proposed expanded warnings with the recommendation that doctors more closely monitor their patients.

"We can do more good by providing more treatment for depressed children and adults," Mann said.

The FDA proposed the changes after completing a review that found use of the drugs may increase the risk of suicidal thoughts and behaviour among young adults 18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning for children led to a falloff in antidepressant prescriptions being written for patients under 18 and an increase in suicides in that age group.

They warned that people with untreated depression about half of those who suffer from the disease face an estimated 15 per cent greater likelihood of death by suicide.

Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor in psychiatry and author of Prozac Backlash, said expanding the warnings wouldn't scare off patients, but instead would allow them to make informed choices.

FDA completes review

The FDA recently completed a review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.

When the results were analyzed by age, it became clear there was an elevated though small and short-term risk for suicidal thoughts and behaviour among adults 18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the risk of suicidal thoughts and behaviour associated with treatment with the drugs. For instance, antidepressants seem to protect against suicidal thoughts and behaviour in adults 30 and older, with the effect most pronounced in patients over 65.

The FDA said the increased risk could mean as many as 14 additional cases of suicidal thoughts or behaviour in every 1,000 children treated with antidepressants. For adults 18 to 24, there could be four additional such cases per 1,000.