Patient safety information for antidepressants has been updated to “improve the prominence and clarity” of warnings about suicidal thoughts and behaviour and sexual dysfunction, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today.
The regulator said that following an “extensive review” by the Commission on Human Medicines (CHM), it will introduce a “series of new measures to strengthen how key risks associated with antidepressant medicines are communicated to patients, carers and healthcare professionals”.
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It said it will update antidepressant patient information leaflets (PILs) to include a “new boxed warning signposting” to information on suicidal thoughts and behaviours that will make the information “easier to find”.
And a “credit card-sized” patient card will be included “in or on the medicine box” to strengthen important safety messaging and inform patients and carers about “how and when to get further support”, it added.
The regulator also said that some antidepressants will have their PILs updated to include the term “post SSRI sexual dysfunction” (PSSD), to inform patients of the risk of symptoms continuing after stopping treatment and “better reflect patient experiences and existing safety information”.
Read more: Antidepressants: MHRA to ‘strengthen’ leaflet suicide warning
It added that it is also developing with other healthcare system partners an ancillary leaflet for patients at their first appointment discussing antidepressants, as well as for patients already on antidepressants.
It said the leaflet, which will be available in 2027, will support “informed decision making” and highlight the “key risks and benefits” about their treatment.
Healthcare professionals have been told to advise patients that suicidal behaviour and thoughts and sexual dysfunction continuing after stopping treatment are “not new risks” but “it is important to be aware of them”.
Patient cards via pharmacies
Department of Health and Social Care parliamentary under-secretary James Frith told parliament earlier this week that since 2020, the MHRA has received four prevention of future death reports concerning the prescribing of antidepressants or their safety information.
He said responses had been issued by the MHRA for all cases, and the regulator had sought the advice of several independent committees on the reports and “the potential need for regulatory action”.
Frith added that the revised PILs and patient cards will be available electronically from this month, with hard copies in medicine packs available “three to six months later”.
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And the MHRA is working with manufacturers’ trade association to “evaluate the feasibility” of early access to the hard copies of the card “via pharmacies”, he said.
MHRA chief safety officer Dr Alison Cave said the aim of the safety information updates is “not to discourage use” of certain medicines, but to ensure “patients, carers and healthcare professionals can have more informed conversations about the benefits and risks associated with antidepressant medicines”.
Read more: Antidepressants to ‘vulnerable patients’ - pharmacist warned
“We are incredibly grateful for the valuable contributions of patients, families, clinicians and experts to this review,” she added.
National Institute for Health and Care Excellence (NICE) patient safety programme manager Chris Bird said the body will “consider the implications of this advice on published NICE guidance and review our recommendations if required”.
It comes after the MHRA confirmed in December that it would revise the safety information in PILs for antidepressants following a “detailed review”.
