Lay Summary: Prescription-event monitoring of alendronate

Alendronate (Fosamax®) is used for the treatment of osteoporosis (thin bones) in women after the menopause. This study analyses medical events reported in patients prescribed alendronate by general practitioners (GPs) in England. The research method used was prescription event monitoring (PEM). Of the questionnaires sent to the GPs of patients issued with a prescription for alendronate between October 1995 and January 1997, 11,916 were returned. The medical events most frequently reported as suspected adverse effects or reasons for stopping alendronate were nausea and vomiting, abdominal pain, dyspepsia, and heartburn caused by inflammation of the oesophagus (gullet). These are all recognized side-effects of alendronate. A few cases of severe skin rash and abnormal blood levels of calcium were suspected to be serious adverse effects of treatment with alendronate. During the study period 540 mostly elderly patients died but there was no suspicion that these deaths were related to treatment with alendronate. This study suggests that alendronate is generally well-tolerated and confirms that some patients develop side-effects affecting the gullet, stomach and gut.