Recalls, warnings, and 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.
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 HCl 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.
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 most common side effects are urinary tract infections and female genital infections. 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 appeared to be 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 effects were nasopharyngitis, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.
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 involving 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.
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.
Idelalisib (Zydelig) to treat relapsed chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL), and small lymphocytic lymphoma (SLL). Safety and effectiveness for CLL were established in a trial of 220 patients, in which combining the new drug with rituximab increased progression-free survival to 10.7 months compared to about 5.5 months on placebo and rituximab. Safety and effectiveness to treat relapsed FL and relapsed SLL were established in a trial of 123 patients with indolent non-Hodgkin lymphoma, in which 54% of those with relapsed FL and 58% of SLL patients had complete or partial disappearance of their cancer. Idelalisib carries a boxed warning on toxicities, including liver toxicity, colitis, pneumonitis, and intestinal perforation. Common side effects include diarrhea, pyrexia, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rash. Common laboratory abnormalities include neutropenia, hypertriglyceridemia, hyperglycemia, and elevated levels of liver enzymes. Idelalisib is intended for patients who have received at least 2 prior systemic therapies.
An expanded approval for ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17, which is associated with poor responses to standard treatment for CLL. The drug's labeling is also changing to reflect that its clinical benefit in treating CLL has been verified following accelerated approval.
Ruconest, a recombinant C1-esterase inhibitor product for the treatment of acute attacks in hereditary angioedema (HAE). The drug is purified from the milk of genetically modified rabbits and intended to restore the level of functional C1-esterase inhibitor in a patient's plasma. Safety and efficacy of this orphan drug were evaluated in a trial of 44 patients, in which the most common adverse reactions were headache, nausea, and diarrhea.
Clinicians should not use hyaluronic acid packaged in a syringe (Expression by Enhancement Medical LLC) as dermal filler, the FDA announced, after adverse events were reported from this unapproved use of the product. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. Instead of this product, one of the FDA-approved fillers should be used, the agency advised.