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arznei-telegramm 2009; 40: 76

 


Paraesthesia due to angiotensin-II receptor antagonists: A 53-year-old man developed bilateral paraesthesia in the finger region after taking olmesartan (OLMETEC, VOTUM) for approximately one month. This did not improve until the angiotensin (AT)-II antagonist was withdrawn (NETZWERK report 12.738). The Netherlands Pharmacovigilance Centre, Lareb, has received 25 reports of paraesthesia in connection with medicinal products in this substance group. In eleven of the people affected, the symptoms improved after withdrawal, and in one woman they resumed after switching to two other AT-II blockers. Four patients were concomitantly taking other medications that are possible causes (omeprazole [ANTRA, generics], statins, beta-blockers) or had diabetes mellitus. The WHO database lists a total of 281 reports of paraesthesia associated with six of the seven AT-II blockers authorised in Germany (Lareb: "Angiotensin-II receptor antagonists and paraesthesia"; available at http://www.lareb.nl). In view of the number and type of reports, this could be a group effect. The 24 suspected reports received by the German Federal Institute for Drugs and Medical Devices (BfArM: letter dated 24 July 2009) suggest this, too. However, in the German Summary of Product Characteristics (SPC), references to paraesthesia or neuralgia as a rare side effect are given only for losartan (MSD Chibropharm: LORZAAR SPC, as at Feb. 2009) and valsartan (DIOVAN, etc.; Novartis Pharma: DIOVAN SPC, as at Dec. 2008). If paraesthesia occurs on angiotensin-II antagonists, the treatment should be switched to a different active principle. It should be noted that paraesthesia occurs frequently on some ACE inhibitors (compare a-t 1999; no. 3: 39-40).



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