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).
A recall of NucliSENS easyMAG magnetic silica for nucleic acid extraction because of potentially inaccurate test results. Kits with the affected lots of magnetic silica have shown a decrease of extraction performance with certain downstream applications, and this detection problem could lead to false-negative or invalid lab test results. The recall includes 1,892 units distributed nationwide.
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 recall of all liquid drug and dietary supplement products produced by PharmaTech, LLC, from Oct. 20, 2015, through July 15, 2016, because of a risk of product contamination with Burkholderia cepacia. There have been no reports of adverse events.
A recall of all lots of lyophilized human chorionic gonadotropin (HCG) and sermorelin aseptically compounded and packaged by Talon Compounding Pharmacy. Products were distributed to patients and clinicians nationwide between Jan. 18 and July 18, 2016. There have been no related reports of illness or injury, but the FDA has expressed concerns about a lack of sterility assurance because the process of lyophilizing HCG and sermorelin has not been verified.
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.
Revised draft guidance on improving dietary supplement companies' new dietary ingredient premarket safety notifications to the FDA. The agency has received fewer than 1,000 notifications of new dietary ingredients since the Dietary Supplement Health and Education Act was passed in 1994. Its revised draft guidance clarifies several points, describes the public health significance of the recommendations, and seeks additional comments before final guidance is published.
An investigation of adverse event reports linked to WEN by Chaz Dean Cleansing Conditioners. Reports include hair loss, hair breakage, balding, itching, and rash, and no possible cause for these events has been determined. Consumers who experience a reaction associated with the product should discontinue use and consult their dermatologist or other clinician.