FDA Antidepressant Warning has Unintended Consequences

decline ssri

We discussed a prior publication in the Archives of General Psychiatry about the decline of antidepressants use after the FDA black box warning. In a more recent study published in the same journal this prior study was criticized because it had some serious limitations. The study used prevalent use instead of incidence use. This means, used all cases instead of the new cases that started using antidepressants and they included all use instead of the use for depression. Antidepressant indications range from major depression to smoking cessation and weight loss, with varied suicidality risk. The warning for heightened suicidality risk was targeted at depressed patients.

This new study used new antidepressant users from the targeted group (children, adolescents, younger adults 18-24 years) and a comparison group of nontargeted adults over a long period from 1997 to 2007 in a large cohort.

Diagnosing decreases persist. Substitute care did not compensate in pediatric and young adult groups, and spillover to adults continued, suggesting that unintended effects are nontransitory, substantial, and diffuse in a large national population.

In all age groups, 5-18, 18-24 and 25-89, depression diagnosis rates were significantly lower than history predicted based. More specific 44% lower for pediatric, 37% lower for young adults, 29% for adults.

The decline in SSRI prescriptions was 10-15%. Not only did SSRI prescriptions decrease in the targeted populations from 5-18 and 18-24 but it also had an unintended effect. The same decline persists in the adult cohort, which was never a target of the advisory or warnings. Luckily no increase in prescriptions of atypical antipsychotics or anxiolytics for depression was found. Psychotherapy increased significantly for adult, though not pediatric, cases.

You could argue that the FDA warning worked. It did but it also spilled over to unintended groups. Moreover, since the debatable suicidality is also influenced by non prescription of effective medication in the targeted population and a clear shift in other forms of treatment such as psychotherapy is minimal also due to a lack of children and adolescent psychiatrists, some action is needed. I think these finding are not limited to the US but probably also apply to The Netherlands and other European countries. Use of SSRIs and Venlafaxine Decreasing among Dutch Children and Adolescents. What do you think?

Related posts on this blog:

SSRI prescription drop associated with suicide increase in children?

7 Posts about Adolescents and Depression
Libby, A., Orton, H., & Valuck, R. (2009). Persisting Decline in Depression Treatment After FDA Warnings Archives of General Psychiatry, 66 (6), 633-639 DOI: 10.1001/archgenpsychiatry.2009.46