Recently Gretchen LeFever Watson wrote on Mad in America about the different boxed warnings on SSRI drugs in Canada and the US. Patients in Canada have been warned since 2004 that these medications carry a risk of suicide and violence including ‘harm toward others’. There are no age restrictions on such warnings. In the US, on the other hand, the ‘harm to others’ clause is not included on drug labels, while the suicide warning is limited to individuals aged 24 and under.
As LeFever Watson points out, there is no reason to believe that these drugs affect people differently depending on which side of the US-Canada border they happen to live on. SSRIs have been implicated in many cases of homicidal ideation and actual homicide regardless of the location. Nor does the evidence show that the risk they pose of harm to others is limited by an arbitrary cut-off age.
Here on the island of Ireland we now have a similar situation pertaining to SSRI drugs whereby patients on one side of the soft border dividing the island are to receive strengthened safety warnings while those on the other side won’t.
Two weeks ago, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new safety measures to improve how the risks of suicidal thoughts and behaviours and post-SSRI sexual dysfunction (PSSD) are communicated to patients taking antidepressants. A new boxed warning to highlight suicide risk will be included on patient information leaflets, and patients will be issued with a card reinforcing key safety messages in electronic and hard copy formats. Furthermore, healthcare professionals are advised to discuss with patients starting or changing an antidepressant dose the risk of suicidal thoughts and behaviours and to highlight that some antidepressants are associated with PSSD. Such additional safety measures will be rolled out in Northern Ireland at the same time as elsewhere in the UK.
However, currently, no enhanced measures of this kind are planned for the Republic of Ireland. As a result, patients living either side of an invisible, open frontier that has no physical infrastructure will be given different information about the same drugs, impacting on patient safety and on the ability to provide informed consent to treatment.
This disparity was raised last week in the Dáil by Mark Ward TD on behalf of families affected by drug-induced suicides. Would the republic’s Health Products Regulatory Authority, HPRA, be adopting the measures implemented in the UK, Minister of State with responsibility for Mental Health, Mary Butler, was asked. Did the Irish Government have a plan to address the disparity?
The response given by Minister Butler was unsatisfactory in several respects. First and foremost, it did not answer or even address the question posed. Instead, overall suicide rates were cited, as were differences in this respect between the Republic of Ireland and Northern Ireland and countries in southern Europe, where, the minister stated somewhat bafflingly, lower rates have been ‘put down to the fact there are some benefits from being in sunlight.’ Some benefits?
Antidepressants were not mentioned at all; nor was the substantive question of how associated risks are communicated to patients on either side of the Irish border. The minister concluded by saying that the question would be referred to the Chief Medical Officer’s office and the Irish College of Psychiatry ‘because anything we do will have to be evidence-based.’
Bereaved families who requested that this question be asked in the Dáil deserved better from Minister Butler. Patients in the republic also deserve better. The open border on our island facilitates the free movement of people and goods, and persistent sexual dysfunction and drug-induced suicidality don’t stop there either.
Meanwhile in both the UK and the Republic of Ireland the risk of ‘harm to others’ is only alluded to indirectly in the small print of patient information leaflets as ‘hostility’, defined as aggression, oppositional behaviour and anger – and exclusively in relation to young people. No change to this will be made as a result of the UK’s new safety measures.
Four different jurisdictions – Canada, the US, the UK and the Republic of Ireland – and four different sets of warnings. Many people are helped by SSRIs but some are seriously harmed by them. The risks are known and well evidenced: akathisia; suicidal thoughts and behaviour at any age; violence including harm to others; PSSD; severe withdrawal effects; and more.
Patients everywhere should have access to the same kind and level of information about the same drugs in order to make informed decisions about whether to go on them in the first place.