Finasteride and Dutasteride: Suicidal ideation and behaviours
The EMA started a review of finasteride and dutasteride-containing medicines at the end of 2024, in response to concerns about suicidal ideation and behaviours.
Tablets containing 1mg of finasteride are authorised in Ireland to treat the early stages of androgenic alopecia in men aged 18 – 41 years.
Tablets containing 5mg of finasteride (Proscar and generics) and capsules containing 0.5mg of dutasteride (Avodart, Combodart, and generics) are authorised in Ireland for the treatment of symptoms of benign prostatic hyperplasia (BPH).
These medicines have a known risk of psychiatric side effects, including depression.
The SPC and PIL for finasteride currently state that mood alterations, including depressed mood, depression, and, less frequently, suicidal ideation, have been reported.
The SPC and PIL for dutasteride currently include depression as a potential side effect.
The EMA safety committee, PRAC have now completed their review and confirmed suicidal ideation as a side effect of finasteride 1 and 5mg tablets. Most cases of suicidal ideation were reported in people using 1mg finasteride tablets, which are used to treat androgenetic alopecia (hair loss due to male hormones). Patients who experience mood changes should seek medical advice and, if taking finasteride 1mg, should also stop treatment. The product information for finasteride 1mg tablets will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction), which are known side effects of the medicine and may contribute to mood changes. A patient card will be included in the packages of 1mg finasteride tablets to remind patients of these risks and to advise them about the appropriate course of action.
Although it was not possible to establish a link between suicidal ideation and dutasteride based on the reviewed data, dutasteride works in the same way as finasteride and therefore, information about the mood changes seen with finasteride will also be added to dutasteride’s product information as a precaution.
Patients taking finasteride or dutasteride should be advised to seek medical advice if experiencing depressed mood, depression or suicidal thoughts.
A direct healthcare professional communication (DHPC) will be sent to relevant healthcare professionals in due course.
Open disclosure practice is outlined in Principle 7 of the PSI’s Code of Conduct for Pharmacists:
“Promote patient safety through open and honest communication with patients, colleagues, and other healthcare professionals. Raise any concerns you may have about patient safety or other safety issues. Be honest when something goes wrong and learn from these incidents. Challenge poor practices and behaviours to improve existing pharmacy practice and always act to foster a culture of patient safety.”
To support IPU members in fostering and promoting open disclosure, an IPU Open Disclosure Policy is available on the IPU’s Open Disclosure webpage, at ipu.ie > Professional > Open Disclosure.
There has been an increase in the availability and use of Systemic Anti-Cancer Treatments (SACT), supportive therapy for managing side effects and co-morbidities, and Oral Anticancer medicines in recent years. Therefore, there are more patients undergoing cancer treatments, and there is an increased footfall of these patients and their carers in community pharmacies. Consequently, community pharmacists have upgraded their skills and knowledge to provide a cancer care service that meets the patient’s needs and engage with a multidisciplinary team to achieve better patient outcomes.
The following resources are available to support pharmacists in their role in cancer prevention, screening, management, and treatment optimisation:
Medicines must be stored following the manufacturer’s specifications to maintain the quality of the medicine supplied to the public. Therefore, those in governance must have procedures in place to ensure that temperatures are monitored in all areas of the pharmacy premises where medicines are stored. Particular attention should be paid to cold chain medicines and potential breaches of the cold chain.
In addition to having the pharmaceutical grade refrigerator serviced on an annual basis to ensure its correct functioning, it is advised that the pharmacy team carry out a visual inspection regularly to ensure that:
For further information, please refer to the PSI guidelines on the storage of medicinal products within a retail pharmacy business, available at psi.ie > Practice Supports > Guidance and Guidelines > Filter by topic > Sourcing Storage and Disposal of Medicines.
Tara Kelly MPSI, Medicines Information Pharmacist, IPU; Lara Marín MPSI, Professional Services Pharmacist, IPU; and Sinéad McCool MPSI, Professional Services/IPU Professional Academy, IPU
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