Actonel official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more. In 2008, the FDA released an alert regarding bisphosphonates such as Fosamax, Actonel, Reclast, and Boniva. The warning noted to consumers that many bisphosphonate users suffered severe bone, muscle, or joint pain during treatment with the drugs. In many cases, patients reported pain that was so debilitating that it interfered with their normal, daily activities. Easy-to-read patient leaflet for Actonel. Includes indications, proper use, special instructions, precautions, and possible side effects. Includes indications, proper use, special instructions, precautions, and possible side effects. Original New Drug Approvals (NDAs and BLAs) by Month All applications approved for the first time during the selected month. Includes New Molecular Entities (NMEs) and new biologics. Osteoporosis drugs Actonel, Fosamax and Boniva already contain numerous warnings about serious side effects. Find out why the FDA is now adding more about femur fractures, requiring manufacturers to distribute consumer guides and asking doctors to reassess whether keeping patients on these dangerous drugs on a long term basis is safe. According to the FDA, doctors wrote more than 150 million prescriptions for bisphosphonates between 2005 and 2009. The drugs work by targeting the body's process of breaking down and regenerating. This information is an update to the FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures issued on March 10, 2010. As a result of these Actonel side effects, the U.S Food and Drug Administration (FDA) reviewed and issued a warning in regard to future use of Actonel. The FDA warning is to clarify to both doctors and patients that because of Actonel side effects, the medication may not be safe if used longer than five years. ACTONEL is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of ≥ 7.5 mg prednisone or equivalent) for chronic diseases. According to an FDA review, further investigation is needed on the long-term risks and benefits of bisphosphonates, drugs used to treat osteoporosis.