Direct healthcare professional communication on the new important advice regarding suicidal ideation and behaviour with use of apremilast (Otezla)
08.11.2016
Celgene Europe Limited, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the new important advice regarding suicidal ideation and behaviour with use of apremilast (Otezla).
Summary
- Suicidal ideation and behaviour have been reported from clinical trials and post-marketing experience (with or without a history of depression) with a frequency of uncommon (≥1/1,000 to ≤1/100), while cases of completed suicide were reported postmarketing in patients taking apremilast.
- The balance of benefits and risks of treatment with apremilast for patients with a history of psychiatric symptoms or patients taking medicines which are likely to cause psychiatric symptoms should be carefully assessed.
- If patients suffer from new or worsening psychiatric symptoms, or if suicidal ideation or suicidal behavior is identified, it is recommended to discontinue treatment with apremilast.
- Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood or of any signs of suicidal ideation.
Further information
Otezla is indicated for treatment of certain adult patients with psoriatic arthritis and chronic plaque psoriasis.
The communication provides healthcare professionals with more detailed information on the reported cases of suicidal ideation and behaviour as well as new recommendations regarding the specified risks.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
