Recalls, alerts, warnings
An expanded recall of epinephrine injection (EpiPen and EpiPen Jr) auto-injectors due to a potential defect that may result in failure to activate. The expanded recall is related to a previous recall of a single lot and includes 13 lots of the 0.3-mg and 0.15–mg strengths of the devices, which were distributed between December 2015 and July 2016. Patients should continue to carry recalled devices until they obtain a replacement product at no cost from a pharmacy (either another EpiPen or a generic form, which is not included in the recall).
A field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010 because they may spontaneously reset during normal operation without sounding an alarm. The manufacturer is providing a software service update to resolve the issue. In the event of a reset, clinicians should transfer the patient to another ventilator. In the 12 reports of reset since August 2012, no patient injury or impairment has been reported.
A recall of all lots of sterile products compounded and packaged by Isomeric Pharmacy Solutions due to lack of sterility assurance. The FDA made these concerns known during a recent inspection. Recalled products were distributed between Oct. 4, 2016, and Feb. 7, 2017. No adverse events have been reported, and the recall does not include any nonsterile compounded medications prepared by the manufacturer.
A recall of all unused StrataMR adjustable valves and shunts due to a post-implantation issue that can lead to potential under-drainage of cerebrospinal fluid. The recall includes a potential 2,622 valves and shunts distributed worldwide and manufactured from Oct. 27, 2015, to Nov. 11, 2016. Symptoms of under-drainage include headaches, nausea, vomiting, and lethargy. If left untreated, under-drainage could lead to coma or death. One patient death has been reported but has not been confirmed to be related to this issue.
A class I recall of the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering electrical shock therapy. The recall includes more than 47,360 devices distributed between Feb. 12, 2004, and Nov. 4, 2016, in the U.S.
Dupilumab (Dupixent) injection to treat adults with moderate-to-severe atopic dermatitis whose symptoms are not adequately controlled by topical therapies. The drug may be used with or without topical corticosteroids. Safety and efficacy were established in three placebo-controlled trials of 2,119 adults. Overall, compared to those who received placebo, those who received the drug achieved a greater response and experienced a reduction in itch after 16 weeks of treatment. Side effects include serious allergic reactions and eye problems, such as conjunctivitis and keratitis. The most common side effects include injection-site reactions, cold sores in the mouth or on the lips, and eye and eyelid inflammation.
Valbenazine (Ingrezza), the first drug approved to treat adults with tardive dyskinesia. Efficacy of the drug, which comes in capsule form, was demonstrated in a placebo-controlled trial of 234 participants. After six weeks, those who received the drug had improvement in the severity of abnormal involuntary movements compared to those who received placebo. Serious side effects include sleepiness and QT prolongation. The drug is contraindicated in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval. The drug was granted fast-track approval and priority review and designated as a breakthrough therapy.
Ocrelizumab (Ocrevus) to treat adults with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). The drug, an intravenous infusion administered by a health care professional, is the first to be approved to treat PPMS. Efficacy was shown in two trials of about 1,650 participants with relapsing forms of MS, who were treated for 96 weeks. Compared to those treated with interferon beta-1a, patients who received ocrelizumab had reduced relapse rates and reduced worsening of disability. In a study of 732 participants with PPMS who were treated for at least 120 weeks, those receiving the drug had a longer time to worsening disability compared to those receiving placebo. The drug may cause serious infusion-related reactions and may increase the risk for malignancies (particularly breast cancer). The most common side effect was upper respiratory tract infection in the trials of patients with relapsing MS, and those with PPMS most commonly experienced upper respiratory tract infection, skin infection, and lower respiratory tract infection. The drug application received priority review, fast-track designation, and breakthrough therapy designation.
A notice that the FDA is investigating the increased rate of major adverse cardiac events in patients with the Absorb GT1 Bioresorbable Vascular Scaffold (BVS). The FDA's initial review of two-year clinical trial data showed an 11% rate of major adverse cardiac events in patients treated with the BVS, compared to 7.9% in patients treated with the approved metallic XIENCE drug-eluting stent. Adverse cardiac events were more likely when the device was placed in small heart vessels.