New skin antibiotic, diabetes drug, and LABA


Recalls, warnings, label changes

A recall of 1 lot each of ibuprofen tablets, 600 mg, and oxcarbazepine tablets, 300 mg (both 100 hospital unit dose), because the ibuprofen packages may contain individual blistered doses labeled as oxcarbazepine. This could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine, which could increase the chances of having a seizure. Also, inadvertent consumption of ibuprofen may cause adverse reactions.

Image from Thinkstock
Image from Thinkstock.

A recall of single-width airway modules (E-MiniC) and accessories and extension models by GE Healthcare because the carbon dioxide detectors may fail or provide incorrect values for mechanically and spontaneous ventilated patients. Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.

A recall of 1 lot of lactated Ringer's and 5% dextrose injection by Hospira due to a confirmed customer report of a particulate within the solution.

A recall of 1 lot of lidocaine HCI injection, 2%, 20 mg per mL single-dose vial, preservative-free, due to visible particles in the solution as well as particulate embedded in the molded glass container, identified as iron oxide.

A recall of 4 lots of intravenous solutions by Baxter after complaints of particulate matter which was later identified as cellulosic fibers and/or plastics.

Alerts on all drugs marketed as sterile by Unique Pharmaceuticals and Downing Labs (aka NuVision Pharmacy) because they may be contaminated, after FDA inspections found unsanitary conditions during production. Clinicians should check their supplies, quarantine any of these drugs found, and not administer them to patients. Use may result in serious infections or death.

Approvals

Oritavancin (Orbactiv) to treat acute bacterial skin and skin structure infections caused by certain susceptible bacteria, including Staphylococcus aureus (methicillin-susceptible and -resistant strains), various Streptococcus species and Enterococcus faecalis. The safety and efficacy of this intravenous drug were evaluated in 2 clinical trials with 1,987 patients which found oritavancin to be as effective as vancomycin. The most common side effects were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs, and diarrhea. The drug label also includes a warning regarding interference with coagulation tests and interaction with warfarin.

Empagliflozin (Jardiance) to treat type 2 diabetes in addition to diet and exercise. Safety and effectiveness of this sodium glucose co-transporter 2 inhibitor were evaluated in 7 clinical trials involving 4,480 patients, which showed that the drug improved HbA1c levels compared to placebo. The drug can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function. Patients who are elderly, have impaired renal function, or are on diuretics seemed more susceptible to this risk. It has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, but should not be used to treat people with type 1 diabetes, diabetic ketoacidosis, severe renal impairment, or end-stage renal disease.

Olodaterol inhalation spray (Striverdi Respimat) to treat chronic obstructive pulmonary disease (COPD). It is a long-acting beta-adrenergic agonist (LABA) that can be used once daily over a long period of time. Safety and effectiveness were evaluated in a trial of 3,104 people with COPD, which showed improved lung function compared to placebo. The drug carries a boxed warning that LABAs increase the risk of asthma-related death. It should not be used in patients with acutely deteriorating COPD and may cause serious side effects, including paradoxical bronchospasm and cardiovascular effects. The most common side were nasopharyngitis, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.

Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER) to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It is an extended-release/long-acting opioid with abuse-deterrent properties. When crushed and snorted, or crushed, dissolved and injected, the naloxone blocks the euphoric effects of oxycodone. Safety and effectiveness were evaluated in a trial of 601 people with chronic low back pain. The most common side effects are nausea and vomiting. The FDA is requiring postmarketing studies to assess risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with long term use beyond 12 weeks.