An FDA advisory committee has narrowly recommended approval of a new antibiotic to treat pneumonia. The committee voted 7-6 that the drug, solithromycin, is as effective as another antibiotic, Avelox (moxifloxacin). However, solithromycin has liver toxicity issues associated with it, according to an FDA review. In addition, agency staff had concerns about a relatively high number of infusion site-related reactions. Solithromycin is related to another antibiotic already on the market, Ketek (telithromycin), that has been linked with liver problems and is not frequently prescribed as a result. The FDA is slated to make a decision on whether or not to approve solithromycin by the end of December. Posted November 7, 2016. Via Reuters.
People who don’t get enough vitamin D may be at increased risk for bladder cancer. That conclusion was made by researchers based on a review of 7 studies conducted by scientists in the UK. Five out of the 7 studies linked low vitamin D levels to an increased risk of bladder cancer, according to a presentation at a medical conference by researchers at the University of Warwick. Prior research has linked vitamin D deficiency with cardiovascular disease, cognitive impairment, autoimmune diseases and cancer. The body naturally produces vitamin D through exposure to sunlight. Although more studies are needed, “our work suggests that low levels of vitamin D in the blood may prevent the cells within the bladder from stimulating an adequate response to abnormal cells,” the study’s lead author said in a news release. Posted November 8, 2016. Via University of Warwick.
The FDA has issued a new rule that limits a tactic used by pharmaceutical companies to delay generic drugs from coming to the market. Filing a “citizen petition” is intended to make the FDA aware of potential concerns with a drug’s risk or effectiveness and trigger a review. However, drug companies have filed such petitions in regard to generic drugs set to become available to delay competition. Brand-name firms filed 92% of the citizen petitions between 2011 and 2015, according to a recent review. More than 9 out of 10 of them were rejected by the FDA. Posted November 9, 2016. Via STAT.