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arznei-telegramm 2011; 42: 32

 


Syncope with ulipristal acetate (ELLAONE): A 17-year-old girl took the progesterone receptor modulator ulipristal acetate (ELLAONE) for emergency contraception. Directly after ingestion severe dizziness developed. Two days later there was a fall in her blood pressure with syncope (NETZWERK report 15.770). It has been known since introduction onto the market that dizziness can frequently occur with ulipristal acetate (a-t 2009; 40: 97-8). Syncope was included in July 2010 under nervous system disorders as a rare undesirable effect in the summary of product characteristics (HRA Pharma: letter dated 2 February 2011). No reports of suspected syncope are known to the Federal Institute for Drugs and Medical Devices (BfArM) from Germany either for ulipristal acetate or for the progestagen levonorgestrel (LEVOGYNON, PIDANA), well established for the same indication (BfArM: letter dated 31 January 2011).



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