ADR that result in revision of patient information
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| Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight |
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1. European Union: Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends that these emergency contraceptives can continue to be used in women of all weights as the benefits are considered to outweigh the risks.
In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate.
Having assessed all the available evidence on the effectiveness of emergency contraceptives, the CHMP considered that the data available are too limited and not robust enough to conclude with certainty that contraceptive effect is reduced with increased bodyweight, as stated in the product information for Norlevo. For levonorgestrel-containing products, some clinical studies have suggested a reduced effectiveness in women with high bodyweight, but in others no trend for a reduced effect with increasing bodyweight was observed. Similarly, for ulipristal acetate, although limited data from clinical trials suggest a possible trend for a reduced contraceptive effect, the data are too limited and insufficiently precise to draw definite conclusions. The CHMP recommended that the results of these studies should be included in the product information of emergency contraceptives, but that the current statements on the impact of bodyweight in the product information for Norlevo should be deleted.
The CHMP considered that, with side effects generally mild, the safety profile of emergency contraceptives is favourable and they can continue to be taken regardless of the woman’s bodyweight. Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse. They should only be used as an occasional ‘rescue’ method as they do not work as well as regular contraceptive methods. The CHMP recommendation will now be sent to the European Commission for a legally binding decision that will be valid throughout the EU.
Healthcare professionals are advised that emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI). The available data are limited and not robust enough to support with certainty the conclusion of decreased contraceptive effect with increased bodyweight/BMI. Healthcare professionals should continue to remind women that emergency contraception is an occasional 'rescue' method and should not replace a regular contraceptive method.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002145.jsp&mid=WC0b01ac058004d5c1
2. The United Kingdom: Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
The EMA have concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether the effectiveness of Levonelle (containing levonorgestrel) and ellaOne (containing ulipristal acetate) was reduced with increased body weight. They concluded that based on the data available the benefits of using these emergency contraceptives remains positive and it cannot be concluded that body weight has an impact on the effectiveness of these widely used medicines.
Healthcare professionals are advised that:
- levonorgestrel and ulipristal acetate can be used for emergency hormonal contraception regardless of the woman's weight or BMI;
- emergency contraceptives should be taken as soon as possible after unprotected sexual intercourse or contraceptive failure;
- emergency contraceptives do not prevent pregnancy in every instance;
- emergency contraception is for use, as the name suggests, in an emergency. It should not be used to replace a regular contraceptive method;
- levonorgestrel containing emergency contraceptives work best if taken within 12 hours of unprotected sex or contraceptive failure but can prevent pregnancy if taken up to 3 days afterwards; and
- ulipristal acetate containing contraceptives can prevent pregnancy if taken up to 5 days after unprotected sexual intercourse or contraceptive failure
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Whatsnew/CON437753
In Hong Kong, there are 29 registered emergency contraceptive medicines containing levonorgestrel and 2 containing ulipristal acetate. All the products are prescription-only medicines. News related to concerns on increased bodyweight affects the effectiveness of the emergency contraceptive medicines has been released by European Medicines Agency (EMA), Health Canada and Therapeutic Goods Administration (TGA), and was posted on the Drug Office website on 4 February, 1 March and 27 March 2014. Letter to healthcare professional has been issued on 27 March 2014 to draw their attention on Health Canada's announcement on warning of reduced effectiveness of emergency contraceptives in women over a certain body weight. The matter is pending for discussion in the meeting of the Registration Committee of the Pharmacy and Poisons Board (the Committee). In view of the new announcement by the EMA and the MHRA that emergency contraceptives remain suitable for women regardless of bodyweight, a letter to healthcare professionals to update the new conclusion will be issued, and the latest information will be provided to the Committee for consideration.
Ends/ Friday, July 25, 2014
Issued at HKT 14:00
side effects generally mild, the safety profile of emergency contraceptives is favourable and they can continue to be taken regardless of the woman’s bodyweight. Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse. They should only be used as an occasional ‘rescue’ method as they do not work as well as regular contraceptive methods. The CHMP recommendation will now be sent to the European Commission for a legally binding decision that will be valid throughout the EU.
Healthcare professionals are advised that emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI). The available data are limited and not robust enough to support with certainty the conclusion of decreased contraceptive effect with increased bodyweight/BMI. Healthcare professionals should continue to remind women that emergency contraception is an occasional 'rescue' method and should not replace a regular contraceptive method.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002145.jsp&mid=WC0b01ac058004d5c1
2. The United Kingdom: Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
The EMA have concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether the effectiveness of Levonelle (containing levonorgestrel) and ellaOne (containing ulipristal acetate) was reduced with increased body weight. They concluded that based on the data available the benefits of using these emergency contraceptives remains positive and it cannot be co |
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