Expanded indications/Labeling changes for February 2010

[chantell.reagan]

Expanded indications/labeling changes:

Benicar (olmesartan) by Daiichi Sankyo
Expanded indication: treatment of hypertension in pediatric patients 6 to 16 years of age

•Link to FDA letter
•Link to prescribing information

Crestor (rosuvastatin) by AstraZeneca
Expanded indication: to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease. (The FDA approval was based on data from the JUPITER study (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin)

•Link to AZ press release 2/10
•Link to prescribing information

Lamictal XR (lamotrigine) by GlaxoSmithKline
Expanded indication: once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures. (This is an expanded label, as Lamictal XR is approved for partial onset seizures (with or without secondary generalization) for patients in this age group).

•Link to GSK press release 1/10

Tykerb (lapatinib) and Femara (letrozole) by GSK and Novartis
Expanded indication: to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women

•Link to GSK press release 1/10
•Link to Tykerb prescribing information

Zyprexa (olanzapine) by Lilly
Labeling change: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia

•Link to FDA Medwatch Zyprexa (olanzapine): Use in Adolescents

Safety issues:

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp
Safety issue: FDA is requiring all ESAs to be prescribed and used under a risk evaluation and mitigation strategy (REMS), to ensure the safe use of these drugs; patients are required to receive a medication guide, while healthcare professionals who prescribe ESAs to patients with cancer must complete a training

•Link to FDA safety communication 2/10

Videx/Videx EC (didanosine) by BMS
Safety issue: may cause non-cirrhotic hypertension in patients, which was discovered through 42 post-market, adverse event reports

•Link to news article 1/10

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER