Recent News
FDA: Clinical Trials Show Increased Risk of Amputation with Invokana
Recent safety communications published by the US Food and Drug Administration indicate that type 2 diabetes drug, Invokana (canagliflozin), can cause increased risk for foot and leg amputations. This announcement was made after data from two clinical studies showed that such amputations were necessary in nearly twice as many patients taking Invokana as compared to…
Redesigned Olympus Scope Linked to Infection Outbreak
Olympus issued a recall of its TJF-Q180V duodenoscope model in January 2016, after reports linked the device to multiple outbreaks of Carbapenem-resistant enterobacteriaceae (CRE), a form of antibiotic resistant infection that is difficult to treat, and often fatal. Further investigation into the incidents revealed that at least 35 people died after suffering infections linked to…
Lack of Communication Cited as Primary Cause of Birth Injuries
Parents spend months preparing for the arrival of their new child to ensure that the child, upon arrival into the world, is secure and healthy. Part of that preparation is partnering with doctors and nurses to ensure a smooth and safe birthing process. Despite this preparation, serious birth injuries affect about 1.5% of US births,…
Government Agency Cites Gaps in FDA’s Reporting System In Power Morcellator Report
In August 2015, The Government Accountability Office (GAO) received requests from 12 US Congress Representatives to investigate the FDA’s handling of adverse event reports regarding laparoscopic power morcellator devices. Such reports claimed that the use of laparoscopic power morcellators spread cancer in those being treated for uterine fibroids. Early this year, the GAO released a…