Other safety alerts
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| Review of emergency contraceptives started |
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1. European Union - Review of emergency contraceptives started
The European Medicines Agency (EMA) has started a review of emergency contraceptives to assess whether increased bodyweight and body mass index (BMI) reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or contraceptive failure. Emergency contraceptives act by blocking and/or delaying ovulation. Available emergency contraceptive medicines in the European Union contain levonorgestrel or ulipristal acetate.
EMA will evaluate the impact of new data suggesting that a high bodyweight could impair the effectiveness of emergency contraceptives. It will assess whether any changes should be made to the product information for all emergency contraceptive medicines containing levonorgestrel or ulipristal acetate. Emergency contraceptives containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure while ulipristal acetate can be used up to 120 hours.
The review of emergency contraceptives started at the request of the Swedish medicines regulatory agency, under Article 31 of Directive 2001/83/EC. It follows a procedure finalised in November 2013 for Norlevo, an emergency contraceptive medicine containing levonorgestrel, to add the following information to the summary of product characteristics: 'In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more, and levonorgestrel was not effective in women who weighed more than 80 kg'. This information is currently not reflected in the product information for other emergency contraceptives containing levonorgestrel. For ulipristal acetate, no information regarding the woman's weight or BMI is currently included in the product information.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002010.jsp&mid=WC0b01ac058004d5c1
2. Canada: Health Canada evaluating whether body weight affects the effectiveness of emergency contraceptive pill
Health Canada is evaluating the effectiveness of levonorgestrel-containing emergency contraception in light of new data that suggests these pills may be less effective in women over a certain weight. Health Canada is aware of the recent statement by the European Medicine's Agency (EMA) regarding this issue. Health Canada, like the EMA, is assessing new data suggesting that a higher body weight could reduce the effectiveness of emergency contraceptives. It is also looking at whether labelling changes will be needed for all levonorgestrel emergency contraceptive products to better reflect the patient population in which these products are effective. As noted in the EMA statement, the product labelling for the drug Norlevo was recently revised in Europe to add the following information: "In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more, and levonorgestrel was not effective in women who weighed more than 80 kg." Health Canada will take appropriate action as required, such as working with the manufacturers to update drug labels and notify Canadians of new information.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../37771a-eng.php
In Hong Kong, there are 28 registered emergency contraceptive medicines containing levonorgestrel and one containing ulipristal. They are prescription only medicines. DH will keep vigilant on any safety updates of the drugs and actions taken by overseas regulatory authorities of any action deemed necessary.
Ends/ Tuesday, February 04, 2014
Issued at HKT 16:00
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