Safety Information

Published: 27 February 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.

Effectiveness of emergency contraception may be reduced in women weighing more than 70kg

27 February 2014

Levonorgestrel 1.5 mg tablet (or 2 x 0.75 mg tablets) is used as an oral emergency contraceptive within 72 hours of unprotected sexual intercourse.

Recent publications have indicated that levonorgestrel may not be effective for women who weigh more than 70 kg.

Irrespective of weight, levonorgestrel may not prevent pregnancy in every case. The sooner you take emergency contraception, the more likely it is that it will work.

Products Affected (Currently Available)

Product name Sponsor
Next Choice Actavis New Zealand Limited
Next Choice Arrow Actavis New Zealand Limited
Postinor-1  REX Medical Ltd

Additional Information

The overall benefit-risk balance of levonorgestrel remains positive.

Women are advised to use emergency contraception as soon as possible and follow the instructions of their healthcare professional.

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

Search for consumer medicine information

Regulator Actions

Medsafe, in conjunction with the Therapeutic Goods Administration (Australia), is continuing to review this safety concern and will provide further information once this review is complete.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (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