Safety Information

Trans-Tasman Early Warning System - Alert Communication

Utrogestan (progesterone) formulation change - important information for patients with a peanut allergy

Update to Original Communication

31 July 2014

Medsafe has been advised that the peanut oil formulation of Utrogestan is no longer available in New Zealand (last stock expired 31 July 2015).

Products affected
Information for consumers and caregivers
Information for healthcare professionals
What actions are Medsafe taking?
How to report adverse events
Further information

Healthcare professionals and consumers are advised that a new formulation of Utrogestan is available in New Zealand that contains sunflower oil instead of peanut oil. The sunflower oil formulation was introduced into New Zealand in October 2012 and the peanut oil formulation is being phased out. However, currently both formulations may be available.

Utrogestan contains the hormone progesterone. Utrogestan is indicated for adjunctive use with oestrogen in post-menopausal women with an intact uterus (as HRT). Utrogestan is also used for progesterone supplementation in women undergoing in vitro fertilisation.

Utrogestan is funded by PHARMAC under special authority for the prevention of pre-term labour in women with a confirmed short cervix or with a history of pre-term birth at less than 28 weeks. This is an unapproved indication.

Medsafe has previously reviewed the risks associated with the use of medicines containing peanut oil in patients with a known peanut allergy. A Prescriber Update article was published in June 2012 which included Utrogestan in the list of peanut oil containing medicines (www.medsafe.govt.nz/profs/PUArticles/BewarePeanutOil.htm).

There is a potential for severe allergic reactions (including possible anaphylaxis) to occur if a patient with a peanut allergy receives the formulation of Utrogestan containing peanut oil instead of the sunflower oil containing formulation.

Products affected

Utrogestan (progesterone) 100mg capsules.

Information for consumers and caregivers

Some medicines contain peanut oil and might cause an allergic reaction in patients with a peanut allergy.
Two different formulations of Utrogestan are currently available in New Zealand — one of the formulations contains peanut oil.
If you have a peanut allergy, please ensure that your doctor and pharmacist are aware of this and ask them to check if any of your medicines might contain peanut oil.
If you have a peanut allergy, please check the product packaging before taking a new medicine. Peanut oil (also known as arachis oil) should be clearly listed as an ingredient.
Utrogestan still contains soya lecithin and must be avoided in patients with a known allergy to soya products.

Information for healthcare professionals

There are currently two different formulations of Utrogestan available in New Zealand — the peanut oil formulation is being phased out.
Please ask patients if they have a peanut allergy before prescribing or dispensing Utrogestan.
If Utrogestan is prescribed to a patient with a known peanut allergy — the prescription should indicate that the patient is allergic to peanuts and should specifically request the sunflower oil formulation.
Utrogestan still contains soya lecithin and must be avoided in patients with a known soya allergy.

What actions are Medsafe taking?

Health professionals and consumers will be informed when the formulation containing peanut oil is no longer available in New Zealand.

How to report adverse events

Online	Submit a CARM report Prescribers can also submit a report using the online reporting tool available in patient management software.
Paper	Download a consumer reporting form (Word Document, 61KB, 1 page) Download a healthcare professional reporting form (PDF, 292 KB, 2 pages) Submit completed forms by emailing CARMreport@health.govt.nz or mail (Medsafe, Ministry of Health, 133 Molesworth Street, Thorndon, Wellington, 6011).
Email	CARMreport@health.govt.nz

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.