Treatment with bisphosphonates may cause atypical fractures of the femur – especially in patients who have received long-term treatment for osteoporosis; concludes the European Medicines Agency, EMA, on the basis of a review it recently completed.
However, the benefits of bisphosphonate-containing medicines continue to outweigh their risks when used according to the approved indications. Bisphosphonates are used to treat osteoporosis by inhibiting bone resorption and increasing bone mineral density.
Warning text in summaries of product characteristics and package leaflets
Based on the result of the review, a warning text will be added to the summaries of product characteristics and package leaflets of all bisphosphonate-containing medicines. The summary of product characteristics describes the pharmacological properties and clinical particulars linked to the use of a medicine. Summaries of product characteristics are written for doctors and other healthcare professionals, and can be found in Danish at www.produktresume.dk.
Signs of atypical fractures
The fractures can occur after minor or no trauma. Many patients feel pain in the thigh or groin weeks or months before a complete fracture occurs. In that period, X-rays will often show signs of stress fracture. In some cases, the fractures may take a long time to heal.
Information for doctors who prescribe bisphosphonates
- The fractures often occur in both legs. Therefore, the opposite leg should also be examined in patients who have been treated with bisphosphonates and who have had a femoral neck fracture. Doctors should weigh the benefits against the risks individually for each patient with suspected atypical femoral fracture before considering ending treatment.
- Patients treated with bisphosphonates should be advised to contact their doctor if they experience pain in thighs, hip or groin.
- The optimal duration of bisphosphonate treatment of osteoporosis has not been determined. Doctors should regularly review the need for continued treatment on the basis of an individual assessment of benefits and risks for each patient – especially after five or more years of use.
- Doctors and patients are encouraged to continue reporting cases of atypical fractures linked to bisphosphonate treatment to the Danish Medicines Agency.