US warning on antidepressants

Patients on some popular antidepressants should be closely monitored for warning signs of suicide, the US government warned today in asking the makers of 10 drugs to add the caution to their labels.

Although the US Food and Drug Administration’s investigation into the possible suicide connection initially focused on children given the drugs, its warning was aimed at both adult and paediatric use.

It is not clear yet that the drugs actually do lead to suicide, the FDA stressed.

But until that is settled, the FDA today followed its advisers’ recommendation, issuing a public health advisory putting doctors, patients, families and other caregivers on notice to be particularly vigilant for signs of worsening depression or suicidal thoughts at the beginning of antidepressant therapy or whenever the dose is changed.

The drugs of concern are all newer generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin.

Most are known to affect the brain chemical serotonin.

British health authorities sounded the alarm last year, saying long-suppressed research suggests certain antidepressants might sometimes increase the risk of suicidal behaviour in children and teenagers.

Because only one drug, Prozac, has been proven to alleviate paediatric depression, Britain declared others – drugs called SSRIs and their close relatives – unsuitable for depressed youth.

The FDA issued a caution on paediatric use last year, but today’s action - especially the addition of the warning to drug labels – goes significantly further.

Dozens of anguished parents pleaded with FDA to add such warnings in a meeting last month, citing pre-teens and teenagers who hanged themselves or slashed their wrists shortly after starting the antidepressants.

A key feature: Parent after parent described a child who had become extremely agitated or anxious shortly after starting the antidepressants, and seemingly sudden impulses that turned deadly.