More than 1,500 additional cases of liver injury have been discovered that are associated with the newest class of hepatitis C drugs. In October, the FDA first identified24 cases involving safety issues related to the 9 new antiviral drugs for hepatitis C, including Harvoni (ledipasvir-sofosbuvir), Olysio (simeprevir) and Sovaldi (sofosbuvir). While these drugs appeared to lower the hep C virus to undetectable levels in the majority of patients, some of them experienced reactivation of hepatitis B that had serious health consequences, including liver transplant and death. An investigation by the Institute for Safe Medicine Practices of FDA adverse events data identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of liver injury. In a further 761 cases, the adverse event was failure of the antiviral drug against the virus. Posted January 25, 2017. Via ISMP.
Almost half of women undergoing treatment for breast cancer experience side effects. Researchers in a study asked 1,945 women with early-stage breast cancer about 7 treatment side effects: nausea and vomiting, diarrhea, constipation, pain, arm swelling, shortness of breath and breast skin irritation. About 45% reported at least one of the side effects was severe or very severe. And when women got chemotherapy, the risk of severe side effects doubled. However, when chemo was conducted with radiation, the odds of severe side effects were just 30% higher. Posted January 24, 2017. Via Cancer.
Last year, the FDA approved only 22 new drugs, a sharp drop from the 45 that were given the green light in 2015. The 22 new medicines are the lowest number approved since 2010. There are several reasons for the decline, according to John Jenkins, director of the FDA Office of New Drugs. There were fewer drug applications filed before the FDA and the agency either delayed or rejected more applications last year compared to the prior 2 years. In addition, 5 drugs whose approval was expected in 2016 ended up winning approval in late 2015. Posted January 2, 2017. Via Reuters.