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GPs warned off-label antidepressant prescribing ‘lacks evidence’

Researchers have urged GPs to be cautious about prescribing off-label antidepressants, after a study found nearly half of drugs prescribed off-label did not have any clear evidence to support their use

The study of 174 primary care doctors in Canada showed that around a third of all prescriptions for antidepressants over a 12-year period were off-label.

Of these, 45% lacked strong scientific evidence to support their use for the indication they were prescribed for, with trazodone for insomnia being the most frequently prescribed drug with no supporting evidence.

Just 16% of prescriptions were backed up by scientific evidence, including amitriptyline for pain, escitalopram for panic disorders and venlafaxine for obsessive compulsive disorders.

Around 40% of prescriptions had evidence to support the off-label prescription of another drug in the same class.

The researchers said the vast number of available drugs can make it difficult GPs to remember which drugs are appropriate for which indications, but also that contraindications and a lack of effective treatments for symptom-based conditions could mean they are turning to off-label antidepressants as a last resort.

‘When evidence to support efficacy is lacking, physicians should exercise caution, prescribe conservatively, and inform patients of this information via a shared decision making process,’ the researchers said.

‘These findings highlight an urgent need to produce more evidence on the risks and benefits of off-label antidepressant use and to provide physicians with this evidence at the point of prescribing.’

Writing in a linked editorial, Professor Bruce Guthrie, professor of primary care, and Dr Daniel Morales, GP and discovery fellow, both from the University of Dundee, said ‘off-label prescribing is common and is often poorly supported by evidence or relies heavily on extrapolating evidence from one situation to another’.

But they also highlighted that ‘these pitfalls are not confined to off-label drugs’ and cautioned that ‘patients and prescribers should be cautious about all extrapolations of evidence whether the proposed treatment is “on-label” or “off-label”.’

They noted that the UK GMC says GPs must be able to justify their decisions on prescribing drugs ‘regardless of whether they are licensed or unlicensed’.

BMJ 2017; available online 21 February

Readers' comments (6)

  • We have several patients on off licence treatments.
    Any advice on now stopping as these patients find the drugs help

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  • Since your picture shows amitriptyline, does this include neuropathic pain? If we switch everyone to pregabalin..........Meds Mgmt will go into meltdown!

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  • this is Not-News surely-If there were strong evidence bases for off licence uses the companies would have then licensed the drugs concerned anyway.also since none of the examples chosen above are commonly addictive -and have plenty of unwanted side -effects- it follows that they only continue to be prescribed when they are working.(Memo to self. must think of a way to audit our documenting of off label uses/consultations before next appraisal...)

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  • every pt is different, one works for one doesnt mean it will work for every one. no harm in trying and continuing if it works for the pt-
    we treat pts individually its not a cattle market .. i hope the i...ts understand who say these statements... or do what 2nd person above states and lets put them in a meltdown

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  • I offer patients with severe PMT off label low dose SSRIs during the second half of their menstrual cycle which many of them have had great success with. Obviously we've exhausted other methods of treatment, lifestyle changes etc and i've counselled them re possible side effects and also given them follow up and stopped the medication within 2 months if it's not working. I also put on the medication instructions that it's for PMT as most patients don't want anyone to think they're on it for depression. No complaints so far and lots of happy patients. Also helps hot flushes if given continuously.

    Waiting for lots of rude responses now....

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  • Re; -

    Off label low-dose SSRIs: - second half of menstrual cycle, severe PMT.

    Both - off-label/on-label antidepressant prescribing.

    POST SSRI SEXUAL DYSFUNCTION. (PSSD). RxISK. 2017.

    "Close to 100% of people who take antidepressants experience some form of sexual side effect".

    "Most people who take an SSRI or an SNRI and some tricyclic antidepressants (clomipramine and imipramine) will feel some form of genital numbing, often within 30 minutes of taking the first dose".

    "PSSD affects both men and women. It can happen after only a few days exposure to an antidepressant and persist for months, years or indefinitely. There is no known cure".

    (Then there is the risk of akathisia, with resulting violence against self and/or others).

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