Safety Information

Revised: 21 November 2014

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 Doxazosin and a possible risk of nightmare (paroniria) added to the medicines monitoring scheme

1 April 2014

Since 1992, the Centre for Adverse Reactions Monitoring (CARM) has received a total of seven reports where the patient experienced nightmare whilst taking doxazosin. In the majority of these reports doxazosin was the sole suspected medicine.

Products Affected

Doxazosin is an alpha-1 adrenergic receptor blocker used to treat high blood pressure and urinary retention associated with benign prostatic hyperplasia (BPH).

Product name Sponsor
Apo-Doxazosin Apotex NZ Ltd
m-Doxazosin Multichem NZ Limited

Additional Information

The overall benefit-risk balance of doxazosin remains positive.

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

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Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring (M² logo) scheme to obtain further information on this possible side effect. Please report any adverse events with doxazosin, in particular suspected nightmare.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to CARM.

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

During the M² logo period (1 April to 31 October 2014), no cases of nightmare associated with the use of doxazosin were reported to CARM. It was concluded that no link between doxazosin and nightmare was demonstrated.

The balance of benefits and risks of harm for doxazosin remains positive and no further action is required at this time.

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