Safety Issues and Adverse Reactions with Osteoporosis Management

Introduction: Osteoporosis is a disease that has spread worldwide and has become a relevant public health problem. Over the last 2 decades, a number of drugs have been licensed for its treatment owing to their efficacy in preventing fragility fractures. The safety profiles of these drugs are well defined with data from extensive programs of pharmacovigilance to support it.

Areas Covered: In this article we reviewed the long-term safety of Bisphosphonates, Calcium, Vitamin D, Selective Estrogen Receptor Modulators, Teriparatide and Denosumab. We excluded hormone replacement therapy that lost its indication for the treatment of osteoporosis. The license for the treatment of osteoporosis of Calcitonin was recently withdrawn and that of Strontium ranelate was severely limited. For both drugs, we report EMA statements about their safety profile.

Expert Opinion: The safety profile of most available drugs for the treatment of osteoporosis is well defined and the most serious adverse events are either rare or predictable. Osteoporosis treatment is a favorable choice in patients at moderate-high risk of fracture, while in patients at low risk pharmacological prevention should involve consideration of the balance between the beneficial effects of treatment, the probability of adverse effects and costs.