Updated warnings on fluoroquinolones, new diabetes drug approved

Details on the latest recalls, warnings, and approvals.


Recalls and warnings

New warnings on fluoroquinolones about the risk of disabling and potentially permanent side effects. Both oral and injectable forms are associated with side effects involving tendons, muscles, joints, nerves, and the central nervous system. Labeling changes include an updated boxed warning and revisions to the warnings and precautions section of the label, which also contains new limitation-of-use statements. Clinicians should limit the use of these antibiotics in patients with less serious bacterial infections, such as acute bacterial sinusitis and uncomplicated urinary tract infections. However, the benefits of the drug class outweigh the risks for some serious bacterial infections, such as anthrax, plague, and bacterial pneumonia. FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, and gemifloxacin (Factive).

Photo by Thinkstock
Photo by Thinkstock

A recall of 2 lots of Comfort Shield Barrier Cream Cloths by Sage Products because of contamination with Burkholderia cepacia. Topically applying a product contaminated with B. cepacia may cause serious infections, particularly in immunocompromised or hospitalized patients. The affected lots of incontinence care cloths were distributed between March 31 and June 8, 2016, and July 18 and 19, 2016.

A recall of 8,750 units of Roadrunner UniGlide hydrophilic wire guides due to potential contamination with glass particles ranging in size of about 4 to 280 µm. Potential adverse events that may occur as a result of the contamination include vessel damage, bleeding, and embolic particulate in the circulatory system. The manufacturer has not received any related reports of adverse events.

A class I recall of AVEA ventilators because an electrical issue may cause an unexpected shutdown. The recall is of 501 devices manufactured between Nov. 13, 2015, and Jan. 4, 2016, and distributed nationwide from Dec. 16, 2015, to Feb. 15, 2016.

A recall of 1 lot of 0.25% bupivacaine hydrochloride injection by Hospira because of the presence of particulate matter within a single vial. Affected products were distributed nationwide to wholesalers and hospitals between December 2015 and January 2016. The manufacturer has initiated a root-cause investigation and will determine corrective and preventive actions.

A recall of 7 lots of amikacin sulfate injection, 500 mg/2 mL (250 mg/mL) and 1 g/4 mL (250 mg/mL) vials, by Teva Pharmaceuticals, due to the potential for the presence of glass particulate matter. No related adverse events have been reported.

A class I recall of AngioDynamics Soft Vu Omni Flush angiographic catheters due to reports of tip separation, which can lead to loss of device function and surgical interventions. The 167 recalled devices were manufactured between Nov. 7, 2003, and Oct. 18, 2008, and distributed from Jan. 5, 2004, to Dec. 3, 2008.

Approvals

Lixisenatide (Adlyxin), a once-daily injection to improve glycemic control in adults with type 2 diabetes. In 10 trials of 5,400 patients, the glucagon-like peptide 1 receptor agonist improved HbA1c levels, both as a stand-alone therapy and with other FDA-approved medications for diabetes. In a cardiovascular outcomes trial of more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease, use of the drug did not increase the risk of cardiovascular adverse events compared to placebo. The most common side effects are nausea, vomiting, headache, diarrhea, and dizziness. Another common side effect is hypoglycemia in patients treated with both the drug and other antidiabetic drugs.

Lifitegrast ophthalmic solution (Xiidra) to treat the signs and symptoms of dry eye disease. The medication is the first lymphocyte function-associated antigen 1 antagonist, a new drug class, to be approved for this indication. In 4 randomized controlled studies of more than 1,000 patients ages 19 to 97 years, those treated with the drug saw more improvement in their eye dryness than those treated with placebo eye drops. The most common side effects were eye irritation, discomfort, blurred vision, and an unusual taste sensation.

Miscellaneous

A recommendation to stop using System 83 Plus automated endoscope reprocessors for reprocessing duodenoscopes. In May, the manufacturer issued an urgent medical device recall and advised its users to transition to alternative methods of reprocessing duodenoscopes because inadequately reprocessed duodenoscopes have been linked to patient infections and death. The products remain in service for reprocessing endoscopes other than duodenoscopes.