Recalls and warnings
A warning about the risk of hepatitis B virus (HBV) reactivating in patients with current or previous infection with HBV who are treated with certain direct-acting antivirals for hepatitis C virus. Citing 24 cases reported between 2013 and 2016, the FDA will require a boxed warning for the drug labels of direct-acting antivirals instructing clinicians to screen and monitor for HBV in all patients receiving these drugs. Of the reported cases, 2 patients died, and 1 required a liver transplant. HBV reactivation usually occurred within 4 to 8 weeks.
A recall of all unexpired IV flush syringes by Nurse Assist because of a potential link to a multistate outbreak of Burkholderia cepacia bloodstream infections. More than 100 patients in the Northeast have reportedly developed these infections while receiving IV care using the prefilled saline flushes, according to the CDC. Recalled products were distributed between Feb. 16 and Sept. 30, 2016.
A warning that clinicians, patients, and caregivers should respond immediately to “elective replacement indicator” alerts for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St. Jude Medical. The batteries in these devices may fail earlier than expected, and some have depleted within 24 hours of the patient receiving an alert, rather than in the normal 3-month lead time for replacement. Without battery power, the devices are unable to deliver lifesaving pacing or shocks. Nearly 350,000 affected devices remain actively implanted worldwide, although the manufacturer has initiated a recall and correction of affected devices.
A nationwide recall of all unexpired Twin-Pass dual-access catheters due to excess manufacturing material at the tip, which may separate from the catheter during use, posing a risk of embolism. No associated injuries have been reported. Of the 5,784 recalled products, which were distributed from October 2014 to September 2016, about 9% are estimated to have the excess material.
The MiniMed 670G hybrid closed-loop system, the first automated insulin delivery device approved for people ages 14 and older with type 1 diabetes. The system includes a sensor that measures glucose levels under the skin and an insulin pump, which is strapped to the body and connected to an infusion patch with a catheter that delivers insulin. It measures glucose levels every 5 minutes, automatically administering or withholding insulin, although users must manually request insulin doses to counter carbohydrate consumption. A clinical trial of 123 participants demonstrated safety, as no serious adverse events, diabetic ketoacidosis, or severe hypoglycemia was reported. Risks include hypoglycemia, hyperglycemia, and skin irritation or redness around the infusion patch. It is contraindicated in patients who require fewer than 8 units of insulin per day.
Adalimumab-atto (Amjevita), a biosimilar to adalimumab (Humira), to treat multiple inflammatory diseases. The drug is approved to treat moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis; moderately to severely active Crohn's disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis. The most common adverse reactions are infections and injection-site reactions.
Three new indications for canakinumab (Ilaris): tumor necrosis factor receptor-associated periodic syndrome, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency, and familial Mediterranean fever. The most common adverse reactions for these indications are injection-site reactions and heightened susceptibility to colds.
The Aera Eustachian Tube Balloon Dilation System to treat persistent Eustachian tube dysfunction. With the system, a catheter is used to insert a small balloon through a patient's nose and into the Eustachian tube and, once inflated, the balloon opens up a pathway for mucus and air to flow through the tube, potentially restoring proper function. The balloon is deflated and removed after dilation. In a randomized controlled trial, 52% of patients undergoing the procedure had normal tympanography results 6 weeks after the procedure, compared to 14% of those treated only with conventional medical management (nasal spray). The most common adverse events are small tears of the tube lining, minor bleeding, and worsening of Eustachian tube dysfunction.
Etanercept-szzs (Erelzi), a biosimilar to etanercept (Enbrel), to treat multiple inflammatory diseases. Administered by injection, the drug is approved to treat certain patients with moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, and chronic moderate to severe plaque psoriasis. The most serious known side effects are infections, neurologic events, congestive heart failure and hematologic events.
An updated safety communication about Mycobacterium chimaerainfections associated with the use of the Stöckert 3T Heater-Cooler System in patients who have undergone cardiothoracic surgery. The FDA has offered new recommendations for facilities that use these devices, including a strong suggestion that they transition away from using devices manufactured prior to September 2014 for open-chest cardiac surgery.
A rule removing 19 specific active ingredients, including triclosan and triclocarban, from over-the-counter antibacterial hand and body washes. Some data have suggested that long-term exposure may pose health risks, such as bacterial resistance or hormonal effects. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers have not demonstrated that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of infection. The rule doesn't apply to consumer hand sanitizers or wipes, or to antibacterial products used in health care settings.