EMA: keine Änderung der Beipackzettel erforderlich

[dieBeate]

Re: EMA request reference ASK-35536

Dear XY,

Thank you for your query of 27 October about intrauterine devices (IUDs) containing levonorgestrel.

EMA has completed its assessment of a signal of anxiety, panic attacks, sleep disorders and restlessness with IUDs containing levonorgestrel (marketed in the EU as Mirena, Jaydess, Levosert and other trade names).

At its meeting of 23-26 October 2017, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there is currently not enough evidence for a possible association between use of these products and anxiety disorders including panic disorder or sleep disorders.

The PRAC considered available data from published studies and post-marketing reports of side effects and noted that when anxiety, panic attacks, sleep disorders and restlessness occurred they were often associated with depression. The data did not show a clear link between levonorgestrel IUDs and these effects in the absence of depression. Mood disorders such …

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