Inhaled insulin and new antibiotic for skin infections approved

Details on the latest recalls, warnings, and label changes, as well as approvals.


Recalls, warnings and label changes

A warning on docetaxel (Taxotere, Docefrez, Docetaxel) that it may cause patients to experience intoxication or feel drunk during and after treatment because it contains ethanol. Clinicians should consider the alcohol content of docetaxel when prescribing or administering the drug, and patients should avoid driving, operating machinery, or performing other such activities for 1 to 2 hours after the infusion. The various formulations of the drug contain different amounts of alcohol, which clinicians should be aware of in order to monitor and counsel patients appropriately.

Image from Thinkstock
Image from Thinkstock.

A recall of 1 lot of 0.5% Marcaine (bupivacaine HCl injection) 30 mL, single-dose vials by Hospira due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution.

A recall of 6 lots of Coumadin (warfarin sodium), 5-mg single-use vials, by Bristol-Myers Squibb due to visible particulate matter found in a small number of unreleased samples.

A recall of Medtronic Duet external drainage and monitoring systems because the patient line tubing may separate from the patient line connectors, which could result in pneumocephalus, infection, and over/under drainage of cerebrospinal fluid.

A recall of Langston V2 dual-lumen catheters due to reports that the inner catheter can separate from the device hub during use, which may require a procedure to retrieve the separated piece from the patient's vascular system.

A recall of Flexi-Seal Control fecal management system kits because they have not been approved by the FDA, and adverse events have been reported. Issues with the device's auto-valve feature may lead to rectal damage, expulsion of the device and/or leakage, fecal soiling, and death.

A revised warning on testosterone products about the risk of venous thromboembolism (VTE). The risk of VTE as a possible consequence of polycythemia is already included in the labeling, but the FDA is requiring a more general warning. The new warning is not related to the ongoing evaluation of the drugs' possible association with increased rates of stroke, heart attack, and death.

A recall of Smiths Medical Portex low dead space connector with sideport, 3.5 mm, due to a single lot of 3.0 mm-sized connectors being mislabeled as 3.5 mm.

A recall of all HydroFinity Hydrophilic Guidewires due to reports of the wire being damaged when the guidewire was withdrawn rapidly, which could potentially result in vessel occlusion.

A recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strips due to a labeling error describing which meter models are compatible with the strips.

Approvals

Tedizolid phosphate (Sivextro) to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant and -susceptible strains), various Streptococcus species, and Enterococcus faecalis. It is available for intravenous and oral use. Safety and efficacy were evaluated in 2 clinical trials with 1,315 adults with ABSSSI which showed similar effectiveness to linezolid. It has not been evaluated in patients with neutropenia, so alternative therapies should be considered.

Afrezza, a rapid-acting, inhaled human insulin, to treat diabetes in adults. It should be administered at the beginning of each meal or within 20 minutes after starting a meal. Safety and effectiveness were evaluated in more than 3,000 patients with type 1 or 2 diabetes. Inhaled insulin is not a substitute for long-acting insulin. It is not recommended for patients who smoke or have chronic lung disease. A boxed warning cites instances of acute bronchospasm in patients with asthma and chronic obstructive pulmonary disease.

Eloctate, the first antihemophilic factor, Fc fusion protein, to control and prevent bleeding in patients with Hemophilia A. The drug was evaluated in a trial of 164 patients that demonstrated that it was effective in the treatment of bleeding episodes, in preventing or reducing bleeding, and in the control of bleeding during and after surgical procedures, and it presented no safety concerns. It is an orphan drug.

A new indication for technetium 99m tilmanocept (Lymphoseek) to determine the extent squamous cell carcinoma has spread in the head and neck. In 2013, the test was approved to help identify lymph nodes in patients with breast cancer or melanoma. Safety and effectiveness in squamous cell carcinoma were established in a trial of 85 patients which showed Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system. The most common side effect was pain or irritation at the injection site.