ADR that result in revision of patient information
|
| |
| European Union: European Medicines Agency starts safety review of Diane 35 and its generics - Pharmacovigilance Risk Assessment Committee to give EU-wide recommendation |
| |
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) formally started a safety review of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35µg), associated names and its generics at its 4-7 February 2013 meeting. The Europe-wide review has been initiated at the request of the French medicines regulatory agency (ANSM), following the announcement of its plan to suspend the marketing authorisations for Diane 35 and its generics for acne treatment in France over the next three months. This was the result of an analysis of known data, including reports of venous and arterial thromboembolism (VTE and ATE, the formation of blood clots in the veins or arteries) recorded in the French national pharmacovigilance database in association with Diane 35 and its generics over a period of more than 20 years.
These medicines have been authorised at the level of individual Member States for many years. They are widely used across Europe. However, their authorised uses differ between Member States. In many countries they are authorised as a contraceptive in women with hormone-related conditions such as acne, hirsutism (excessive growth of hair on the face) and alopecia (loss of hair). In France, they are only authorised for the treatment of acne, but ANSM has noted wide-spread off-label use as a contraceptive. The risk of venous thromboembolism with these medicines is low but well known, and warnings are included in their product information to alert patients and prescribers to the risks. European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country. Therefore, the PRAC will evaluate all available evidence on the benefits and risks of these medicines and give a recommendation on whether their marketing authorisations should remain as they are, be varied, suspended or revoked, in the interest of all patients in the European Union. It is expected that the PRAC will adopt a recommendation at its 13-16 May 2013 meeting.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001711.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, Diane-35 Tab (HK-43330) is registered by Bayer Healthcare Ltd and there are other nine generic products with same ingredients registered in Hong Kong. All are prescription-only medicines and have package inserts including precaution of blood clot. Related news has been released by the European Medicines Agency, Health Canada and Therapeutic Goods Administration of Australia, and was posted on the website of Drug Office on 31 January, 1 February and 6 February 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 31 January 2013. The Department of Health will keep vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, February 09, 2013
Issued at HKT 12:00
|
| |
|
