FDA statement on access to opioids for patients with chronic, end-of-life pain
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…
FDA requires new labeling for fluoroquinolone antibiotics
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…
FDA: US will no longer perform Zika tests on individual blood donations
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…
FDA letter updates risks of Type III endoleaks with aortic endovascular graft systems
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…
FDA issues Safety Alert for compounded drugs containing triamcinolone, moxifloxacin
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.…
FDA: Hospira recalls two lots of Naloxone Hydrochloride Injection
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…
FDA updates recommendations to reduce surgical fires
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…
FDA issues Class I Recall of CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope
Editor's Note The Food & Drug Administration on June 6 identified the recall by Maquet Datascope Corp of its CARDIOSAVE Hybrid Intra-aortic Balloon Pump as Class I, the most serious. The recall was initiated because of a design issue that allows fluid to seep into the device, which can lead…
FDA: New labeling for liquid-filled intragastric balloons
Editor's Note The Food & Drug Administration on June 4 announced that it had approved new labeling on potential risks for liquid-filled intragastric balloons by Apollo Endosurgery and ReShape Lifesciences. The new labeling for the Orbera and ReShape balloon systems includes more information about possible deaths linked to the use…
FDA: Recall of STAT-Check and Medline manual resuscitator bags
Editor's Note The Food & Drug Administration on June 1 announced the recall by SunMed Holdings of 18,808 units of its STAT-Check and Medline manual resuscitator bags. The recall was initiated because the patient port retaining ring of the bags may not fully seat, which could allow the patient port…
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