Off label prescribing remains common

The older antidepressants have lost the market for treatment of depression. Worldwide. SSRIs are now off patent, and available for depression, and anxiety.

But there are other uses. This paper in the BMJ will not shock a single physician.

Overall, 29.3% (95% confidence interval 26.6% to 32.3%) of all antidepressant prescriptions were written for an off-label indication . By class, TCAs had the highest prevalence of off-label indications (81.4%, 77.3% to 85.5%), followed by other antidepressants (trazodone, bupropion, and mirtazapine; 42.4%, 37.1% to 47.7%) and SSRIs (21.8%, 19.0% to 25.0%). By contrast, the prevalence of off-label indications was much lower for serotonin-norepinephrine (noradrenaline) reuptake inhibitors (SNRIs; 6.1%, 4.8% to 7.5%). The high prevalence of off-label indications for TCAs was mostly due to amitriptyline, which was only approved for depression but was almost exclusively prescribed for off-label indications (93.0%, 89.6% to 95.7%)—most commonly pain (48.4%, 39.7% to 57.8%), insomnia (22.5%, 13.6% to 31.3%), and migraine (16.7%, 12.2% to 21.9%; table 2?). The high prevalence of off-label indications among other antidepressants (trazodone, bupropion, and mirtazapine) was largely due to trazodone, which was mostly prescribed for insomnia (82.5%, 74.5% to 88.1%) even though it was not approved for this indication. SSRIs and SNRIs had a lower prevalence of off-label indications because they were more frequently prescribed for depression than TCAs, which by definition was an approved indication for all antidepressants

The relevant tables are below.

The trouble is that this is a database study. It describes what is on the ground: it took some years. During that time, indications for medications changed. For better or ill. Better would be to consider dose, evidence and why this was done. This happens in peer review. It cannot happen in this kind of study.

But I’m not shocked. The results are expected.

2 thoughts on “Off label prescribing remains common

  1. Of course, a drug license is for direct and explicit marketing for a specific diagnostic – and was not intended to regulate clinical usage.

    Nowadays, most Big Pharma marketing is indirect – and via control of the medical research literature, especially randomised controlled trials- also by management of meetings, consensus and guidelines.

    But I think we currently have the worst of both worlds – licensing does not prevent gross abuses (such as multi-drug cocktails of all-known psychiatric drug classes for so-called Bipolar II disorder diagnosed in about 1/20 people; or the use of antipsychotics in children and immature adolescents) — but licensing is (rhetorically) used to make doctors unconfident and indeed afraid about using old, cheaper and safer drugs for indications licensed for new/ expensive/ on-patent drugs.

    1. I am on a commitee writing guidelines at present, and I have Cochrane asking about drug monies from the 1990s.

      There is pressure. To this jobbing psychiatrist, Bipolar II and adolescent Bipolar don’t exist. Kraepilin had described the phenonema in his monograph manic depressive psychosis. But then, I do not consider DSM 5 an authority, but a series of best guesses.

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