Acitretin: Prescriber action needed

Update Medicines

The Special Authority for acitretin contains a requirement that prescribers warn people of childbearing potential of the risk of teratogenicity (birth defects).

View the current Special Authority form(external link)

Datasheet update

The current datasheet for acitretin states that teratogenicity is a risk for up to 3 years after treatment, this was updated in October 2019. Until recently, PHARMAC’s Special Authority said that teratogenicity was a risk for up to 2 years.

Action to take

We are asking prescribers to ensure that people who have been prescribed acitretin in the last 3 years are aware of the change to the datasheet.

For people of childbearing potential, we ask that you alert them to the risk of teratogenicity for up to 3 years after treatment has ended.

Everyone prescribed acitretin should also be warned not to give blood for 3 years after treatment has ended.

Find more information:

NZ Formulary acitretin monograph(external link)

Medsafe datasheet for Novatretin(external link) [PDF]

Medsafe’s March 2020 Prescriber Update(external link) 

Special Authority error

We updated the acitretin Special Authority form in March 2021 for gender neutral language. At that stage, we accidentally changed the length of time teratogenicity was a risk from 2 years to 1 month. This error was corrected by April 2021 and all prescribers who applied for a Special Authority during this time period were directly notified of the error.

On discovering the error, we became aware that the datasheet had changed in late 2019 to say there was a risk for 3 years.

We apologise for our error. While PHARMAC does not provide clinical advice, we acknowledge that some prescribers may have relied on the information on PHARMAC’s Special Authority form.

Check the sources of clinical advice

We remind prescribers to always check Medsafe data sheets and NZ Formulary for the latest clinical information about treatments.

Search Medsafe’s datasheets(external link)

Search the NZ Formulary(external link)

We note that Medsafe’s advice is that it is the supplier’s responsibility to make known any changes to datasheets.

See Section 7.2 of Guideline on the Regulation of Therapeutic Products in New Zealand Part 8: Pharmacovigilance – Medsafe’s website(external link)

Special Authority review

We’re currently checking whether other Special Authority forms contain information that might be viewed as clinical advice. The criteria in Special Authorities only relate to the eligibility for funding; they do not cover the breadth and depth of clinical practice.

People who have taken acitretin

If you have taken acitretin in the last 3 years and can get pregnant, we recommend you contact your doctor or the person who prescribed the acitretin.