New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Bisphosphonates and Atypical Fractures Oct 13, 2010 FDA MedWatch Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. The median BP treatment duration in patients with atypical subtrochanteric and femoral shaft fractures is 7 years. The FDA recommends: • Evaluate any patient who presents with new thigh or groin pain to rule out a femoral fracture. More than half of patients reported with atypical femoral fractures have had a prodrome of thigh or groin pain before suffering an overt break. Bisphosphonates and Atypical Fractures Educate physicians and patients about this symptom and for physicians to ask patients on BPs and other potent antiresorptive agents about thigh or groin pain. Complaints of thigh or groin pain in a patient on BPs require urgent radiographic evaluation of both femurs (even if pain is unilateral). • Discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. anecdotal findings suggest that teriparatide therapy can improve or hasten healing of these fractures • Consider periodic reevaluation of the need for continued bisphosphonate therapy, particularly in patients who have been treated for over 5 years. Patients without a recent fracture and with femoral neck T scores > -2.5 after the initial therapeutic course, consideration may be given to a “drug holiday” Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Pioglitazone and Bladder Cancer? • September 17, 2010 FDA Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer – After Two Years Exposure In preclinical carcinogenicity studies of pioglitazone, bladder tumors were observed in male rats receiving doses of pioglitazone that produced blood drug levels equivalent to those resulting from a clinical dose. – Additionally, results from two, three-year controlled clinical studies of Actos (the PROactive study and a liver safety study) demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators – A ten-year, observational cohort study as well as a nested case-control study in patients with diabetes who are members of Kaiser Permanente Northern California (KPNC) health plan. • A planned five-year interim analysis was performed with data collected from January 1, 1997 through April 30, 2008, the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure Pioglitazone and Bladder Cancer? • Update 6-16-2011 The FDA warned that the diabetes drug Actos, known generically as pioglitazone, increases the risk of bladder cancer by at least 40% when used for more than a year or in higher cumulative doses. The agency said it will require changes in the label of the drug to reflect the new findings. • The FDA is not taking any further action against Actos until it receives further results from an ongoing study of the drug, but France has already suspended sales and Germany has warned physicians not to prescribe the drug to new patients. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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