Other safety alerts
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| The United Kingdom: Intrauterine contraception: uterine perforation - updated information on risk factors |
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Intrauterine contraception includes levonorgestrel-releasing IUSs and copper IUDs. IUSs are licensed for several gynaecological conditions in the UK, including:
• long-term contraception (Jaydess, Levosert, Mirena)
• heavy menstrual bleeding (Levosert, Mirena)
• protection from endometrial hyperplasia during oestrogen replacement therapy (Mirena)
Use of intrauterine contraception can rarely result in uterine perforation. Perforation most often occurs during insertion, but might not be detected until some time later. The European Active Surveillance Study for Intrauterine Devices (EURAS-IUD) was an observational study which examined the risk of uterine perforation with intrauterine contraception. The study followed 43,078 women who used levonorgestrel-releasing IUSs and 18,370 women who used copper IUDs.
The results review that the risk of perforation was increased in the following instances (details can be found in the MHRA's website):
• in women who were lactating (compared with women not lactating) at the time of insertion
• when the IUS or IUD was inserted up to 36 weeks (compared with more than 36 weeks) after giving birth
These risk factors were independent of the type of intrauterine contraception inserted.
The benefits of intrauterine contraception still strongly outweigh the rare risk of perforation for most women, including those who are lactating or have recently given birth. Therefore the MHRA has not put in place any new restrictions on use of intrauterine contraception based on the study findings. The summaries of product characteristics and patient information leaflets in the UK have been updated.
Healthcare professionals are advised of the following before inserting an intrauterine system (IUS) or intrauterine device (IUD):
• inform women that perforation occurs in less than 1 in 1,000 women and that the symptoms include:
• severe pelvic pain after insertion (worse than period cramps)
• pain or heavy bleeding after insertion which continues for more than a few weeks
• sudden changes in periods
• pain during sex
• not being able to feel the threads
Healthcare professionals should explain to women how to check their threads and tell them to return for a check-up if they cannot feel them (especially if they also have significant pain). Partial perforation may have occurred even if the threads can still be seen; consider this if there is severe pain following insertion.
Please refer to the following website in MHRA for details:
https://www.gov.uk/drug-safety-update/intrauterine-contraception-uterine-perforation-updated-information-on-risk-factors
In Hong Kong, there is one registered pharmaceutical product which is an IUS, namely Mirena Intrauterine system 52mg (HK-41251) which contains levonorgestrel. It is a prescription-only medicine registered by Bayer Healthcare Ltd (Bayer). So far, the Department of Health (DH) has not received any adverse drug reaction report on the product. Bayer has submitted an application to the DH to update the package insert of the product to include the relevant warning, and the application is under evaluation. In view of the MHRA's announcement, letters to healthcare professionals will be issued, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will remain vigilant on any safety updates of the drug.
Ends/ Saturday, June 27, 2015
Issued at HKT 13:00 |
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