The FDA reports that the Chantix (varenicline) drug label now contains updated efficacy and safety information. In addition to updated information on using varenicline in stable cardiovascular disease and information on using varenicline in patients with chronic obstructive pulmonary disease (COPD), the new label includes alternative directions for patients to select a quit smoking date. The alternative instructions tell patients to begin taking the drug, and then select a target quit date between day 8 and day 35 of treatment.
The FDA is continuing to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of esophageal cancer. The agency is reviewing data from published studies, which have reported conflicting findings on this risk. However, FDA believes at this time that the benefits of these drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks.
The FDA approved Zytiga (abiraterone acetate) in combination with prednisone (a corticosteroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).