Eye Events in Patients Receiving Risedronate
Background
In the UK, risedronate is used for the prevention and treatment of osteoporosis (thin bones), mainly in postmenopausal women, and to treat Paget’s disease (a condition which leads to bone deformities). There have been case reports of adverse drug reactions affecting the eye in patients taking risedronate or similar medicines published in the medical literature. During a prescription-event monitoring (PEM) study of risedronate the reporting of adverse events affecting the eye was notable. The aim of this research was to evaluate these reports in detail.
Methods
The PEM study of risedronate was conducted in England between September 2000 and June 2002. Subequently general practitioners (GPs) were asked for follow-up information on selected events affecting the eye. Based on the information provided, events followed up were classified as either ‘probably’, ‘possibly’ or ‘unlikely’ to be related to risedronate. If insufficient information was obtained from the follow-up questionnaire, cases were categorised as ‘unassessable’.
Results
Of the total study population of 13,643 patients, 11,156 (82%) were females and 2,398 (18%) were males. We received 359 reports of adverse events affecting the eye in 313 patients. Of these we followed up 178 patients. Nineteen patients experienced eye events assessed as possibly or probably related to risedronate. The age range for these patients was 50-92 years and the time to onset of symptoms from the start of treatment ranged from 7 days to 5 months. Dry eye (six reports), sore eye (five reports) and inflammation of the conjunctiva (three reports) were the most frequently reported eye events which were assessed as probably or possibly related to risedronate. GPs also reported five other cases of inflammatory conditions affecting the eye. However, the information received on those events was insufficient to make an assessment of whether or not they were caused by risedronate.
Conclusion
Patients receiving risedronate can develop a variety of signs and symptoms affecting the eye, with differing degrees of severity. In some patients eye symptoms may develop after the first month of treatment. Doctors should be vigilant for possible adverse reactions affecting the eye in patients receiving this medicine