Revised: 21 November 2014

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.

Allopurinol and lichenoid-type skin reactions added to the medicines monitoring scheme

9 April 2014

Since 1971 the Centre for Adverse Reactions Monitoring (CARM) have received four reports of lichenoid-type reactions. The last report was received in 2013.

Lichenoid-type skin reactions include lichenoid keratosis and lichen planus.

More information on these skin reactions can be found on DermNet.

Products Affected

Allopurinol inhibits uric acid production and is used to manage gout and hyperuricaemia.

Product name	Sponsor
Allopurinol	Sandoz
Apo-allopurinol	Apotex

Additional Information

The benefits of allopurinol continue to outweigh the risk of harm.

This reaction has been linked to use of other medicines and by some sources to allopurinol, but is not listed in the allopurinol data sheets.

Allopurinol is known to cause serious skin reactions (such as DRESS) and should be discontinued at the first sign of rash.

Advice on how to take this medicine and other possible side effects can be found in the consumer medicine information (CMI) and data sheets.

Search for consumer medicine information

Search for data sheet information

Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring () scheme to obtain further information on this possible side effect. Please report any adverse events with allopurinol particularly lichenoid-type skin reactions.

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.

How to report an adverse reaction

Update to Original Communication

21 November 2014

This safety concern has been investigated through . No further cases were received. It was concluded that no link between allopurinol and lichenoid type skin reactions was demonstrated. The balance of benefits and risks of harm for allopurinol remains positive and no further action is required at this time.

Medsafe will re-investigate this concern should more information become available.