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Safety Information

Trans-Tasman Early Warning System - Alert Communication

Discontinuation of oral ketoconazole (Nizoral) 200mg tablets

12 November 2013

Products affected
Information for consumers and caregivers
Information for healthcare professionals
How to report
Further information

Discontinuation Date

1 December 2013

Healthcare professionals and consumers are advised that Janssen-Cilag (New Zealand) is discontinuing oral ketoconazole (Nizoral) 200mg tablets.

Oral ketoconazole tablets are a prescription medicine used to treat fungal infections. Due to ongoing safety concerns regarding liver injury with the use of oral ketoconazole tablets, the manufacturer has decided to stop making this medicine. This adverse reaction is well known with oral ketoconazole and was most recently discussed by the Medicines Adverse Reactions Committee (MARC) in September 2011.

Minutes of the 147th MARC meeting – 8 September 2011

Products affected

From 1 December 2013 the company will stop supplying oral ketoconazole (Nizoral) 200mg tablets. Topical (on the skin) ketoconazole products, including shampoos and cream, are not affected by these safety concerns and will continue to be available.

Information for consumers and caregivers

  • If you are currently taking oral ketoconazole, talk to your doctor about switching to an alternative antifungal treatment. Do not stop taking this medicine without first discussing it with your doctor.
  • If you are taking oral ketoconazole seek immediate medical help if you experience nausea, vomiting, anorexia, yellow skin and eyes (jaundice), stomach pain or dark urine.
  • If you are using topical formulations of ketoconazole (shampoos or cream), continue your treatment as directed by your healthcare professional as these products are not affected by these safety concerns.
  • If you have any concerns or questions, please talk to your healthcare professional.

 

Information for healthcare professionals

  • Patients requiring long-term alternative treatments will need to be changed to an alternative antifungal treatment.
  • Topical ketoconazole formulations have low systemic absorption and therefore are not affected by these safety concerns and will continue to be available.
  • Janssen-Cilag (New Zealand) will provide more information in a letter to you.

How to report

Healthcare professionals and consumers are encouraged to continue reporting any adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Phone 03 479 7247 to speak to a Medical Advisor at CARM
From your iPhone using the ADR online app
Online Submit an online report
Prescribers can submit using the online reporting tool available in patient management software
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail (address is on the card)
Email carmnz@otago.ac.nz
Fax 03 479 7150

Further information

Medsafe cannot give advice about an individual’s medical condition.If you have any concerns about oral ketoconazole Medsafe encourages you to talk to your healthcare professional or contact Janssen-Cilag Medical Information on 0800 800 806.

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