Approvals for an oral anticoagulant, weight-loss device, and generic esomeprazole

Details on the latest recalls, warnings, and approvals.

Recalls, warnings, label changes

A recall of 1 lot of 0.9% sodium chloride injection, 250 mL, by Hospira due to 1 confirmed report of a particulate, which was identified as a human hair, sealed in the bag at the additive port area.

A safety communication about endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes and the risk that their design may impede effective reprocessing. Multidrug-resistant bacterial infections have been reported, even when reprocessing instructions are followed correctly. The FDA is actively monitoring the situation and working with other government agencies and manufacturers to identify the causes and risk factors for transmission and to develop solutions. In the interim, clinicians should inform patients of the benefits and risks of ERCP, and discuss symptoms of infection to watch for after a procedure.

Photo by Thinkstock
Photo by Thinkstock

A label change for varenicline (Chantix) warning about the drug's potential alcohol interaction, rare risk of seizures, and ongoing research into side effects on mood, behavior, or thinking. Clinicians should advise patients to reduce their consumption of alcohol when beginning the drug, and to stop taking the drug if they develop changes in mood or behavior. The risk of seizures should be weighed against the potential benefits of varenicline in patients with particular risk of seizure.

A recall of certain lots of colistimethate and rifampin for injection by Heritage and 2 lots of atracurium besylate injection by Sagent due to a lack of sterility assurance based on FDA observations at the manufacturer, Emcure Pharmaceuticals.


Edoxaban (Savaysa) tablets to reduce the risk of stroke and embolism in patients with atrial fibrillation that is not caused by a heart valve problem, as well as to treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anticlotting drug for 5 to 10 days. Safety and efficacy are based on a trial of 21,105 participants in which edoxaban reduced stroke and clot risk similarly to warfarin with less major bleeding. In a trial of DVT and PE patients, rates of symptomatic recurrent venous thromboembolism were similar to those with warfarin. The most common side effects were bleeding and anemia. The drug carries a boxed warning about issues in specific patient groups, including those with atrial fibrillation and a creatinine clearance greater than 95 mL/min, and the risk of spinal or epidural hematomas.

The first generic version of esomeprazole (Nexium) to treat gastroesophageal reflux disease in adults and children ages 1 and older, as well as to reduce the risk of gastric ulcers associated with use of NSAIDs, treat Helicobacter pylori along with certain antibiotics, and treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome. The generic version will be dispensed with a medication guide mentioning the risk of stomach problems, including severe diarrhea, and that multiple daily doses of proton-pump inhibitors for a long period may cause an increased risk of bone fractures.

Glyxambi, a combination of empagliflozin (10 or 25 mg) and linagliptin (5 mg), to improve glycemic control in adults with type 2 diabetes. Efficacy was shown in trials comparing the combination pill plus metformin with each of the included drugs plus metformin. It does not treat type 1 diabetes or diabetic ketoacidosis and should not be taken by patients with severe renal impairment, end-stage renal disease, dialysis, or hypersensitivity reactions to linagliptin or empagliflozin. It has not been studied in patients with a history of pancreatitis, and there have been postmarketing reports of acute pancreatitis with linagliptin. The most common adverse reactions to the combination drug are urinary tract infection, nasopharyngitis, and upper respiratory tract infection.

A waiver for a nucleic acid-based influenza test (the Alere i Influenza A & B test) to be used outside of laboratories. It can now be distributed to sites including physicians' offices, emergency departments, and health department clinics. The test uses a nasal swab sample from a patient and provides results in about 15 minutes. Negative results do not rule out influenza virus infection; the test is intended to aid in diagnosis along with the evaluation of other risk factors. The test was first cleared in June 2014 as a prescription-only device.

The Maestro Rechargeable System, a weight-loss device for patients age 18 and older who have not been able to lose weight with a weight-loss program and who have a body mass index of 35 to 45 kg/m2 with at least 1 other obesity-related condition, such as type 2 diabetes. The device targets the nerve pathway between the brain and the stomach and consists of a rechargeable electrical pulse generator, wire leads, and electrodes implanted surgically into the abdomen. In a trial, patients with the device lost 8.5% more weight in a year than controls. The clinical study did not meet its original end point, but the FDA concluded that the benefits outweighed risks of the device. Serious adverse events include nausea, pain at the device site, vomiting, and surgical complications. Other adverse events include pain, heartburn, problems swallowing, belching, mild nausea, and chest pain.

Secukinumab (Cosentyx) to treat moderate-to-severe plaque psoriasis. The drug binds to the interleukin-17A protein and is administered as an injection under the skin. It is intended for patients who are candidates for systemic therapy, phototherapy, or both. Safety and effectiveness are based on trials of 2,403 participants showing greater clinical response with the drug than placebo. It is approved with a medication guide about the increased risk of infection. Serious allergic reactions have been reported, and caution should be exercised in patients with a chronic infection, history of recurrent infection, or active Crohn disease. The most common side effects include diarrhea and upper respiratory infections.

Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B for patients age 10 through 25 years. It is the second vaccine of this type to be approved. Effectiveness is based on studies of 2,600 adolescents and young adults who received 2 doses, after which 62% to 88% had antibodies in their blood that killed 3 different N. meningitidis serogroup B strains, compared with 0% to 23% before vaccination. The most commonly reported side effects were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

Parathyroid hormone (Natpara) to control hypocalcemia in patients with hypoparathyroidism. Safety and effectiveness were evaluated in a clinical trial of 124 participants in which 42% of treated participants achieved normal blood calcium levels on reduced doses of calcium supplements and active forms of vitamin D, compared to 3% on placebo. The drug carries a boxed warning that osteosarcoma has been observed in rat studies and that, because of this potential risk, it is only recommended for use in patients whose hypocalcemia cannot be controlled on calcium supplementation and active forms of vitamin D. The most common side effects are paraesthesia, low blood calcium, headache, high blood calcium, and nausea.

The Dexcom Share app, for patients with diabetes using a continuous glucose monitor (CGM). It allows them to automatically and securely view data from their CGMs on their own phones and share them with another designated user's Apple mobile device.

An expanded approval for ranibizumab injection (Lucentis) to treat diabetic retinopathy in patients with diabetic macular edema (DME).The most common side effects include bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure. Serious side effects include endophthalmitis and retinal detachments. The drug was previously approved to treat DME and macular edema secondary to retinal vein occlusions.

An expanded indication for ibrutinib (Imbruvica) to treat Waldenström's macroglobulinemia. Approval was based on a trial of 63 participants with a 62% overall response rate and a duration of response ranging from 2.8 to 18.8 months. The most common side effects were thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash. Clinicians should inform patients of the risk of hemorrhage, infections, atrial fibrillation, second primary malignancies, tumor lysis syndrome, and embryo-fetal toxicity. The drug was previously approved for mantle cell lymphoma and chronic lymphocytic leukemia.

A new indication for lisdexamfetamine dimesylate (Vyvanse) to treat binge-eating disorder in adults. Efficacy is based on multiple trials including 724 adults in which those taking the drug experienced a decrease in the number of binge-eating days per week and had fewer obsessive-compulsive binge-eating behaviors compared to placebo. It is dispensed with a medication guide about risks, including psychiatric problems and heart complications. The most common side effects are dry mouth, insomnia, increased heart rate, jittery feelings, constipation, and anxiety. The drug was previously approved to treat attention deficit hyperactivity disorder.

Palbociclib (Ibrance) to treat metastatic breast cancer in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole. Efficacy was demonstrated in a trial with 165 participants that showed 20.2 months average progression-free survival in patients on the drug, compared to about 10.2 months in those receiving only letrozole. The most common side effects are neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis.

TissuGlu, the first tissue adhesive approved for internal use. The urethane-based adhesive can be used to connect tissue flaps made during abdominoplasty surgery. Efficacy is based on a trial with 130 participants, in which 73% of the adhesive-treated patients required no postoperative interventions to drain fluid; they were also generally able to return to most daily activities sooner than those who had surgical drains. There was no difference between the groups in reported levels of pain or discomfort due to the surgery.

The ENROUTE Transcarotid Neuroprotection System to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure. Approval is based on a trial showing that the rate of stroke, heart attack, and death among patients treated with the device was 3.5%, although 14.2% had a serious adverse event.


The use of pain medicines during pregnancy should be carefully considered, the FDA concluded after a recent evaluation of the medical literature on the topic, including studies on prescription NSAIDs, opioids, and acetaminophen. The evidence is too limited to draw any definitive conclusions, so the agency's recommendations on use of pain medicines during pregnancy will remain the same at this time.