PHARM.D

Avastin No Longer Approved for Breast Cancer - FDA The US Food and Drug Administration (FDA) announced today that it is rescinding its approval of bevacizumab ( Avastin , Genentech) for treating metastatic breast cancer because the drug has not proven itself to be safe and effective for that indication. In a press conference today, FDA Commissioner Margaret Hamburg, MD, explained that bevacizumab received market clearance in 2008 under an accelerated approval pathway that required further studies to confirm its safety and efficacy. Two additional clinical trials, Dr. Hamburg said, failed to confirm the drug's initial promise. Women who receive bevacizumab for metastatic breast cancer, Dr. Hamburg said, risk potentially fatal adverse events without proof that the drug's use will provide a benefit — specifically, a delay in tumor growth — justifying that risk. In addition, there is no evidence that bevacizumab will help patients live longer or improve their quality of life....

Multivitamin use and breast cancer incidence in a prospective cohort of   Swedish women Susanna C Larsson, Agneta A kesson, Leif Bergkvist, and Alicja Wolk ABSTRACT Background: Many women use multivitamins in the belief that these supplements will prevent chronic diseases such as cancer and cardiovascular disease. However, whether the use of multivitamins affects the risk of breast cancer is unclear. Objective: We prospectively examined the association between multivitamin use and the incidence of invasive breast cancer in The Swedish Mammography Cohort. Design: In 1997, 35,329 cancer-free women completed a self administered questionnaire that solicited information on multivitamin use as well as other breast cancer risk factors. Relative risks (RRs) and 95% CIs were calculated by using Cox proportional hazard models and adjusted for breast cancer risk factors. Results: During a mean follow-up of 9.5 y, 974 women were diagnosed with incident breast cancer. Multivitamin use...

Clofazimine alters the energy metabolism and inhibits the growth rate of a human lung-cancer cell line in vitro and in vivo. The anti-leprosy drug Clofazimine is known to inhibit respiratory function and hence energy metabolism in yeast and in transformed fibroblasts. The aim of this study was to examine the effect of Clofazimine on the energy metabolism of a chemoresistant human non-small-cell bronchial-carcinoma cell line (WIL) and to determine whether this agent might inhibit the growth rate of this cell line in vitro and in vivo. Oxidative phosphorylation was estimated in vitro by measuring oxygen consumption polarographically and glycolysis was estimated from lactate production. In cells that had been pre-treated with an ATP synthetase inhibitor (oligomycin), the addition of Clofazimine resulted in an increase in oxygen consumption similar to that observed with 2,4-dinitrophenol, a classical inhibitor of oxidative phosphorylation. This inhibition of mitochondrial function was ass...

FDA Warns of Prostate Cancer Risk With Reductase Inhibitors Roxanne Nelson The US Food and Drug Administration (FDA) has alerted healthcare professionals about changes in the labeling for 5-alpha reductase inhibitors (5-ARI), which include dutasteride and finasteride. The drug labels now warn that there is an increased risk of being diagnosed with a high-grade prostate cancer while taking these drugs. Both drugs are marketed for use in benign prostate hypertrophy and have also been investigated for — but not approved for — prostate cancer prevention in men at high risk. However, it was in these studies looking at prostate cancer prevention that there was a finding of an increased incidence of high-grade prostate cancer. The FDA acknowledges that the risk appears to be low but says that practitioners need to be aware of this safety information. The known benefits can then be more accurately weighed against the potential risks when clinicians make a decision about starting...