Editor's Note The Food and Drug Administration (FDA) on August 3 issued a warning for azithromycin, saying the antibiotic should not be given long-term to prevent an inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. A clinical trial…
Editor's Note The Food and Drug Administration (FDA) on July 25 issued an update for the Zoll LifeVest 4000 wearable cardioverter defibrillator. The update provides information on efforts by Zoll to remedy the potential hazard of the device failing to deliver a life-saving shock if not replaced soon after displaying…
Editor's Note The Food and Drug Administration (FDA) on July 19 finalized its guidance for using electronic health record (EHR) data in FDA-regulated clinical studies. The guidance is meant to encourage the use of EHR data in clinical studies and promote greater interoperability between EHR and electronic data capture systems.…
Editor's Note Food & Drug Administration (FDA) commissioner, Scott Gottlieb, MD, on July 9 issued a statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with the need to stem the misuse and abuse of opioids. As the FDA considers new steps to address the…
Editor's Note The Food & Drug Administration announced on July 10 that it was requiring labeling changes for fluoroquinolone antibiotics because they may cause significant decreases in blood sugar and mental health side effects. The labels will add that low blood sugar levels can lead to coma and make the…
Editor's Note The Food & Drug Administration (FDA) on July 6 announced that individual blood donations no longer need to be screened for Zika virus, “unless there is an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area that would trigger individual donation testing in…
Editor's Note In a June 19 letter to healthcare providers, the Food & Drug Administration (FDA) says it continues to evaluate information from several sources, including manufacturers, on the risks associated with Type III endoleaks with various endovascular graft systems used for treatment of abdominal aortic aneurysms (AAAs) and aorto-iliac…
Editor's Note The Food & Drug Administration (FDA) on June 14 issued a Safety Alert for compounded drugs containing triamcinolone and moxifloxacin by Guardian Pharmacy Services (Dallas, Texas). At least 43 patients have reported adverse events after receiving eye injections of the compounded triamcinolone and moxifloxacin drug during cataract surgery.…
Editor's Note The Food & Drug Administration on June 4 announced the recall by Hospira, Inc, of two lots of its opioid antagonist Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69). The two lots, 72680LL and 76510LL, were recalled because…
Editor's Note The Food & Drug Administration (FDA) on June 5 updated its Safety Communication: “Recommendations to Reduce Surgical Fires and Related Patient Injury.” Among the recommendations: Perform a fire risk assessment before each surgical procedure. Encourage communication among anesthesia personnel, surgeons, and OR staff. Practice safe use and administration…