FDA looks at link between medications, depression

HEALTH

Federal regulators warn that an array of drugs could play a role in spurring thoughts of suicide or other psychiatric symptoms.

As symptoms of depression go, there is none much clearer than having thoughts of suicide.

But a spate of recent announcements from federal health officials suggests a surprising new interpretation of suicidal fantasies and the depression they are thought to signal: Sometimes, sadness, anxiety and self-destructive thoughts are not symptoms but side effects -- of medicine.

In this year alone, federal regulators have warned that a surprising array of drugs could play a role in spurring thoughts of self-destruction. Medicines that treat epilepsy, asthma and influenza are now under suspicion, as is one that helps smokers kick the tobacco habit.

The FDA stresses that it has established no direct causal link between these medications and suicidal thoughts in patients taking them. But in all the cases, regulators acknowledge they had one of two indicators of potential trouble.

In some cases, a review of a drug's early clinical trials turned up increased rates of suicidal thinking among subjects taking the medicine. In others, the tip-off came when the FDA observed an uptick of reports that patients taking a medication for some other condition developed symptoms of depression.

As a result, FDA officials and medical researchers now are scouring their data for clear signs that these drugs increase the risk of dangerous psychiatric symptoms. Moving forward, the agency will require developers of many new drugs to test for psychiatric side effects that could tip the balance between a new medicine's risks and benefits.

"We're trying to develop systematic strategies for looking . . . in a more rigorous way" for links between drugs and unintended psychiatric effects, said Dr. Thomas Laughren, director of the FDA's division of psychiatry products. "The difficulty is that we have such a primitive understanding of human behavior on a biological level . . . it is hard to predict which compounds are going to have psychiatric effects."

FDA warnings

The recent rash of advisories comes just four years after the FDA first suggested a connection. Prompted by reports that suggested children taking antidepressants were more likely, not less, to commit suicide, the agency in 2004 warned that antidepressants might actually increase the risk of suicidal fantasies and behaviors among children. That link is now in doubt, after recent studies showed a rise in youth suicide even as antidepressant use in that population has plummeted.


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