FDA Suicide Anti-Depressant Warning

The FDA says that adults who use antidepressants should be closely monitored for warning signs of suicide, especially when they first start medication or when they change dosage.

Both in the United States and Britain, much of the concern over suicide and antidepressants has been focused on children who use the drugs. After the British National Health Service banned some SSRIs for children, the FDA -under pressure- stated there is a real, but small, increase in risk of suicidal behavior for children and ordered a "Black Label" warning on all antidepressants to say so.

A year ago, the FDA issued a warning that adults, too, may be at increased risk. Then the agency began reanalyzing hundreds of studies of the drugs to try to determine the risk, and told makers to add or strengthen suicide-related warnings on their labels in the meantime.

Their own internal meta-study, plus some newly published studies in medical journals, have caused the FDA to issue the current public health advisory.

The advisory cautions doctors and patients to watch closely for suicidal thinking or worsening depression and seek medical care if it happens.

There is no question that antidepressants have helped many people recover from depression.  However, the increased risk of suicide, though small, appears to be real.

Clinicians say there appears to be a window period of risk just after the beginning of a medication regimen, before the depression is lessened but when some patients experience more energy and intensity, motivating them to act on suicidal tendencies. The antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.

The FDA also released a notice about a higher-than-expected rate of suicide attempts in research with the nation's newest antidepressant, Eli Lilly's Cymbalta. The agency insisted when it approved Cymbalta last year that studies of depressed patients showed no suicide link. More research needs to be done.

FDA Advisory: http://www.fda.gov/cder/drug/advisory/SSRI200507.htm