Safety Information

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² Logo Isotretinoin and Obsessive Compulsive Disorder (OCD) added to the Medicines Monitoring scheme

14 August 2018

Monitoring finishes 31 March 2019

Products Affected
Additional information
Regulator actions
Reporting
References

The Centre for Adverse Reactions Monitoring (CARM) has received a report of a 14 year old male who developed obsessive compulsive disorder (OCD) and other anxiety symptoms shortly after starting treatment with oral isotretinoin for acne. Isotretinoin treatment was stopped several weeks later, but there was no improvement in his symptoms.

A search of the World Health Organization (WHO) global adverse reaction database, VigiBase, identified 106 case reports in which OCD was reported in association with isotretinoin. The cases were poorly documented, and it has not been possible to identify a causal association between isotretinoin and OCD based on these reports.

The Medicines Adverse Reactions Committee (MARC) reviewed available information at its 174th meeting on 3 July 2018. The MARC agreed that at present there is insufficient evidence of a causal association between isotretinoin and OCD. However, the MARC recommended additional monitoring to encourage reporting of other cases of OCD in patients taking oral isotretinoin.

Products Affected

Product Name Sponsor
Oratane Douglas Pharmaceuticals Ltd
Isotane Mylan New Zealand Ltd

Additional information

Isotretinoin is a medicine used to treat severe acne.

Information on the known psychiatric side effects associated with the use of isotretinoin is included in the New Zealand data sheets for Oratane and Isotane1,2. The data sheets indicate that depression, psychosis and suicidality have been reported in patients treated with isotretinoin, although a causal relationship has not been established. Take care when prescribing isotretinoin to patients with a history of depression, and monitor all patients for signs of depression and refer appropriately if necessary.

The overall benefit-risk balance of isotretinoin remains positive. Advice on how to take this medicine and the known side effects can be found in the consumer medicine information and data sheets.

Search for consumer medicine information and data sheets

Search for information on obsessive compulsive disorder, depression and other health conditions on the Health Navigator website.

Regulator Actions

Medsafe is placing this safety concern on the Medicines Monitoring (M² Logo) scheme to encourage reporting of other cases of OCD in patients taking oral isotretinoin for acne.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring.

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

References
  1. Douglas Pharmaceuticals Ltd. ORATANE Capsules (isotretinoin 5 mg, 10 mg , 20 mg, 30 mg and 40 mg), New Zealand Data Sheet (27 March 2018). Available at: http://medsafe.govt.nz/profs/Datasheet/o/oratanecap.pdf
  2.  Mylan New Zealand Ltd. ISOTANE Capsules (isotretinoin 10 mg and 20 mg), New Zealand Data Sheet (27 February 2018). Available at: http://medsafe.govt.nz/profs/Datasheet/i/isotanecap.pdf