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arznei-telegramm 2013; 44: 16

 


Tongue ulcer on alendronate (FOSAMAX, generics): The day after taking the second weekly dose of the bisphosphonate alendronate (FOSAMAX, generics), which she swallowed with water and without letting it stay in her mouth, as prescribed, a 73-year-old woman awoke with pronounced swelling in the region of the left lower half of her face and severe pain and paraesthesia in the tongue area. On examination in hospital, 3 x 1.5 cm livid discolouration of the tongue was observed. An exploratory biopsy histologically revealed aphthoid mucosal ulcerations with no signs of malignancy. Alendronate was stopped. After about eight weeks, the facial swelling had subsided. Three months after the onset of the symptoms, however, the patient was treated with local anaesthetics for agonising paraesthesia (NETZWERK Report 16.215). Oropharyngeal ulcerations are described as a rare adverse effect of alendronate (MSD: FOSAMAX SPC, as at Oct. 2012). In most cases, these ulcerations are likely to be due to taking the medication incorrectly, e.g. sucking or not swallowing immediately. According to a current review of published case reports, ulcers in the mouth are documented in only one out of a total of 13 patients after correct administration. The sufferers were mainly treated unsuccessfully at first, before alendronate was stopped or the medication was taken correctly as instructed. In the case of oral ulcers, the possibility of an adverse drug reaction should therefore be considered at an early stage (KHARAZMI, M. et al.: J. Oral. Maxillofac. Surg. 2012; 70: 830-6). The BfArM overviews 354 suspected reports of stomatitis or ulcerations in the mouth on alendronate treatment from home and abroad, while osteonecrosis of the jaw was described at the same time in 300 reports (BfArM: letters dated 3 and 5 Dec. 2012).



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