Selective Serotonin Reuptake Inhibitors: Labelling and Packaging
The question
To ask the Secretary of State for Health and Social Care, what discussions he has had with Selective Serotonin Reuptake Inhibitors (SSRIs) manufacturers on the effectiveness of the packaging and labelling of SSRIs in warning patients of (a) the associated risks, (b) suicidal thoughts as a side effect of their use and (c) withdrawal symptoms.
Answered by Dr Zubir Ahmed
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that selective serotonin reuptake inhibitor (SSRI) packaging and labelling produced by marketing authorisation holders (MAHs) reflects what is known about the safety of these medicines for patients on all associated risks or side effects, including suicidal thoughts and withdrawal symptoms.
The product information can be updated based on new safety data or to address concerns. The MHRA wrote to the MAHs of SSRIs to inform them of an independent expert working group (EWG) review into how the risk of suicidal behaviour and sexual dysfunction where symptoms continue are communicated in patient leaflets. Updates to the statutory patient information leaflets (PILs) for antidepressants were agreed for the risk of “post-SSRI sexual dysfunction” for some of the 28 antidepressants involved in the review. The EWG recommended that proposed updates to the PILs on the risk of suicidal behaviour should be tested by a group of patients with a range of mental health conditions and the MHRA is currently exploring the most appropriate way to take this advice forward
In addition to this work, a review into how the risk of withdrawal symptoms is communicated in the SSRI and other antidepressants patient leaflets will be started by the MHRA later in the year and all affected MAHs will be informed.
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