Adverse effects of drugs for osteoporosis

This chapter addresses key safety aspects of pharmacotherapy for osteoporosis and briefly also new drugs in phase III trials. It focuses on risk estimates than on pathophysiology and draws on data from both clinical trials and postlicensing observational studies. Observational post authorization safety studies (PASS) are designed to assess the public health burden of any potential unwanted effect/s when drugs are used in the community after regulatory approval. In 2012, Dell reviewed femur fracture X-rays in the Kaiser California radiology database to estimate the incidence rate of atypical femur fractures (AFFs) as a function of duration of bisphosphonate use. AFFs are rare, but not unknown, in persons who have not used antiresorptive treatment. Other anti-osteoporosis drugs such as strontium ranelate, raloxifene, and more recently, in pre-marketing studies, odanacatib have been associated with an increased risk of thromboembolic and cardiovascular events. The chapter discusses the safety profile of bone formation (anabolic) agents.