Continue to follow the recommendations in. ..

FDA Drug Safety Communication: Security update for drugs against osteoporosis, bisphosphonates, and atypical fractures

Security Announcements [10-13-2010] Food and Drug Administration (FDA) update the public on the information previously reported describe the risk of atypical hip fractures, known as podvertelnyh and diaphyseal femoral fractures in patients taking bisphosphonates to treat osteoporosis. This information will be added to >> << Warning labels of all bisphosphonates drugs approved for the prevention and treatment of osteoporosis. Bisphosphonates class of drugs that can be effective in preventing or slowing bone loss (osteoporosis) in postmenopausal women, which reduces the overall risk of osteoporotic fractures. Fractures caused by osteoporosis can lead to pain, hospitalization and surgery. Atypical podvertelnyh fractures of the femur bone fractures just below the hip joint. Diaphyseal fractures of the femur occurring in the long part of the femur. These fractures are very rare and seems to be less than 1% of all hip and hip fractures in general. Although it is not clear if bisphosphonates are the cause of these unusual fractures of the femur were mainly reported in patients taking bisphosphonates. Bisphosphonates, which are affected by this notice only those approved for the treatment of osteoporosis, including

(and their generics). affects bisphosphonates drugs used for treatment of Paget's disease or high blood calcium levels due to cancer (ie, Didronel, Zometa, Skelid, and their generics). Although the optimal duration of bisphosphonates to treat osteoporosis is unknown, these atypical fractures may be associated with long-term use of bisphosphonates. FDA requires new restrictions on the use of statement >> << Indications and use of labels for these drugs. This statement will describe the uncertainty of optimal duration of bisphosphonates for the treatment and / or prevention of osteoporosis. Medication Guide will also need to give patients when they raise their prescription bisphosphonates. This guide will describe the symptoms of atypical hip fracture and recommends that patients inform their doctor if they develop symptoms. These actions are part of the ongoing review of safety of bisphosphonates and the emergence of atypical podvertelnyh and diaphyseal fractures of the femur, as announced earlier. More information for patients, if you are currently taking bisphosphonates, you should:

Continue to take medication if you say to stop your doctor. Talk to your doctor if you develop a new hip or thigh pain (usually described as dull or aching pain), or you have a problem with drugs. Please report any side effects of bisphosphonates drugs MedWatch program, FDA, using the information at the bottom of the page in the Contacts. More information for health professionals aware of the risk of atypical podvertelnyh and diaphyseal femoral fractures in patients taking bisphosphonates. Continue to follow the recommendations in the drug label when prescribing bisphosphonates. Discuss the known benefits and potential risks of bisphosphonates in patients. Evaluation of any patient with a new hip or groin pain, to prevent hip fractures. Stop powerful antiresorptive medications (including bisphosphonates) in patients with femoral shaft fracture certificate. Consider a periodic reassessment of the need to continue therapy bisphosphonates, especially in patients treated for 5 years. Please report any side effects when using bisphosphonates to the MedWatch program, FDA, using the information at the bottom of the page in the Contacts. Any information provided to MedWatch should be as detailed and include information on fracture location / configuration, the magnitude of injury, fracture details (complete or incomplete, bilateral or crushed), presence and duration of prodromal thigh or groin pain, duration of bisphosphonates use appropriate medical history and concomitant use of other drugs. Summary FDA has considered all available data, including data contained in the American society for bone and mineral research (ASBMR) Task Force report on bisphosphonates and atypical podvertelnyh and diaphyseal fractures of the femur, released September 14, 2010. These atypical femur fractures can occur in any part of the femur, just below the lower Spit support above nadmyschelkovyh flash, and transverse or oblique brief orientation with no signs of grinding. Fractures may be complete (involving both the cortex) or incomplete (including the lateral cortex only), and may be bilateral. Many patients report prodromal pain in the affected area usually presents as a dull, aching hips, weeks or months until failure occurs. The exact frequency of atypical femoral fractures is unknown, but appears to constitute less than one percent of the thigh and hip fractures in general. Thus, atypical fractures are very rare. Although atypical femoral fractures were mainly reported in patients taking bisphosphonates, they also were reported in patients who did not receive bisphosphonates.

The optimal duration of bisphosphonates to treat osteoporosis, is unknown. Bisphosphonates drugs approved for preventing and / or treatment of osteoporosis in these clinical trials support the effectiveness of reduction of fracture with at least 3 years of treatment, and in some cases after 5 years. FDA is continuing its assessment of the data to prove safety and efficacy of long-term use (more lasix drug interactions than 3 to 5 years) bisphosphonates for the treatment and prevention of osteoporosis and provide additional instructions to complete our review. Therefore, FDA continues to review the current safety of bisphosphonates and the emergence of atypical fractures of the femur. As this message, FDA, patients notice and medical professionals new >> << Warnings and Precautions information that is added to this risk on the labels of all bisphosphonates products approved for the prevention and treatment of osteoporosis. New restrictions on the use of statement will describe the uncertainty of optimal duration of bisphosphonates for the treatment and / or prevention of osteoporosis. In addition, FDA requires that Medication Guide be included in all bisphosphonates drugs approved for osteoporosis indications to better inform patients risk of hip fractures atypical. Shane E, D Burr, Ebelinh PR and others. Atypical podvertelnyh and diaphyseal fractures of the femur: report of the Task Force American Society of bone and mineral research [published before printing]. Journal of bone and mineral research. 2010,. On September 17, 2010. .