EMA recommends double dose of LNG EC when used with enzyme-inducers

On May 2016, the European Medicines Agency (EMA) recommended the use of a non-hormonal emergency contraceptive (EC) when a woman in need of EC is using other interacting medicines (such as the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy, and herbal medicines containing St John’s wort). If using a cooper IUD is not an option, the EMA recommends doubling the dose of levonorgestrel (1500 microgram tablets).

The Agency’s Committee for Medicinal Products for Human Use (CHMP) issued this recommendation upon a review for Levonelle and associated names. The effectiveness of 3mg LNG-EC in women taking enzyme-inducing medications has not been studied, but no concerns are identified in relation to safety or side effects associated with the use of this dose.

On 1 August 2016 the European Commission issued a EU-wide legally binding decision to implement the EMA´s recommendation. The EMA has requested that changes be made on LNG EC product packages and leaflets, in order to ensure the correct use.

Read the EMA´s assessment and the statement issued by the Clinical Effectiveness Unit of the United Kingdom´s Faculty of Sexual and Reproductive Healthcare on this matter.

Sources:

European Medicines Agency. Levonelle 1500 microgram tablets and associated namesgoo.gl/v0JttY (accessed 27 September 2016)

FSRH Clinical Effectiveness Unit. Statement from the Clinical Effectiveness Unit. Use of double dose (3mg) levonorgestrel emergency contraception by women taking enzyme-inducing medications. 2 July 2016. https://www.fsrh.org/standards-and-guidance/documents/ceu-statement-double-dose-lng-ec-2-july-2016/ (accessed 27 September 2016)