Recalls and alerts
A class I recall of the Ovation iX Abdominal Stent Graft System by Endologix Inc. due to risks of liquid polymer leaks during implantation. The root cause for most polymer leaks was a material weakness caused during the manufacturing process. The recall includes 5,403 devices distributed from Aug. 31, 2015, to present.
An alert to clinicians about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents. The affected agents are vecuronium bromide for injection (10 mg and 20 mg per vial) manufactured by Gland Pharma and distributed by Fresenius Kabi and rocuronium bromide injection (50-mg/5-mL and 100-mg/10-mL vials) by Gland Pharma and Mylan Institutional. As a temporary measure to increase supply of these drugs, the FDA is not objecting to their distribution without the warning statement from June through September 2020 and from June through July 2020, respectively.
An alert for patients, caregivers, and clinicians to immediately inspect certain lots of epinephrine auto-injectors (0.3 mg) by Amneal and Impax to ensure the yellow “stop collar” is present inside the clear part of the device. If the auto-injector is missing this component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient. If the yellow “stop collar” is not visible, gently rotate the blue sheath remover until it comes into view. If it is present, the product is safe to use.
Revocation of the emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate. The authorization allowed clinicians to use chloroquine and hydroxychloroquine donated to the Strategic National Stockpile to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable. Based on its ongoing analysis of the authorization and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses. In addition, considering the ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of the two drugs no longer outweigh the known and potential risks for the authorized use, the agency said.
A warning about a potential drug interaction related to the investigational antiviral drug remdesivir. The drug has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended, as it may result in reduced antiviral activity of remdesivir, the FDA said.
A recommendation to stop using COVID-19 antibody tests that are listed on the FDA's “removed” test list. The list includes tests where significant clinical performance problems were identified, tests for which an emergency use authorization request has not been submitted, and tests voluntarily withdrawn by their manufacturers. Several antibody tests have had their emergency use authorizations revoked. The FDA keeps an up-to-date list on its “FAQs on Testing for SARS-CoV-2” website.
Emergency use authorizations revising which respirators are authorized to be decontaminated for reuse by certain systems. Authorizations were revised for non-National Institute for Occupational Safety and Health-approved disposable filtering facepiece respirators manufactured in China, as well as for multiple decontamination systems. Clinicians should not reuse a respirator that is incompatible with an authorized decontamination system, even if it has been decontaminated.
An emergency use authorization for the BioMedInnovations SuppleVent Ventilator. The ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation in an ICU or other hospital environment.
An emergency use authorization for the NASA VITAL. The ventilator is the second developed by the National Aeronautics and Space Administration. Whereas the first ventilator relied on wall gas as the pressure source, the second uses an internal compressor for its energy source.
An emergency use authorization for the Fitbit Flow. The continuous respiratory support system includes an FDA-cleared manual resuscitator and was designed for use in treating patients with COVID-19.
An emergency use authorization for the AustinP51, a portable emergency-use resuscitator, to treat adults during the COVID-19 pandemic. The resuscitator is designed to provide either continuous or intermittent ventilatory support for patients requiring mechanical ventilation through volume control.
An emergency use authorization for the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected by clinicians from individuals with suspected COVID-19. The test is the first COVID-19 diagnostic test utilizing next-generation sequence technology.
A letter to clinicians and clinical laboratory staff about a safety risk with using transport media and SARS-CoV-2 testing platforms that are not compatible. There is a risk of exposure to harmful cyanide gas when certain transport media are used with an incompatible testing platform or laboratory process that uses bleach. Although there have been reports of these potentially hazardous interactions, no associated injuries have been reported to the FDA.
Imipenem-cilastatin and relebactam (Recarbrio) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients ages 18 years and older. In a randomized trial of 535 hospitalized adults with HABP/VABP due to gram-negative bacteria, 16% of patients who received the combination died by day 28, compared with 21% of those who received piperacillin-tazobactam. The most common adverse reactions were increased liver enzymes, anemia, diarrhea, hypokalemia, and hyponatremia. The drug combination was previously approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options. It should not be used in patients who are prone to seizures and other central nervous system disorders or in those with previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams, and other allergens.
Pertuzumab, trastuzumab, and hyaluronidase-zzxf for subcutaneous injection (Phesgo) to treat HER2-positive breast cancer. The drug combination is initially used with chemotherapy and may continue to be administered at home by a qualified health care professional once the chemotherapy regimen is finished. Patients should be selected for the treatment based on an FDA-approved companion diagnostic test. A noninferiority study found that the drug combination had efficacy and safety comparable to IV pertuzumab and IV trastuzumab, except for a higher rate of administration-related reactions. It carries a boxed warning about heart failure, fetal harm, and lung toxicity. The most common side effects were alopecia, nausea, diarrhea, anemia, and asthenia. The drug can also worsen chemotherapy-induced neutropenia.
A new indication for canakinumab injection (Ilaris) for the treatment of active Still's disease, including adult-onset Still's disease. Safety and efficacy were established based on extrapolation from treatment of systemic juvenile idiopathic arthritis, for which the drug was previously approved. Common side effects include infections, abdominal pain, and injection-site reactions.
Burosumab-twza injection (Crysvita) to treat tumor-induced osteomalacia. Safety and efficacy were evaluated in two studies of a total of 27 adults with tumor-induced osteomalacia, which causes low phosphate blood levels and bone softening. In both studies, the drug helped achieve and maintain normal phosphate levels. The most common side effects were tooth abscess, muscle spasms, dizziness, constipation, injection-site reaction, rash, and headaches. Hypersensitivity reactions have also been reported. The drug is also approved to treat X-linked hypophosphatemia.
Inebilizumab-cdon IV injection (Uplizna) to treat neuromyelitis optica spectrum disorder in patients who are positive for the anti-aquaporin-4 antibody. In a clinical trial, patients who received the drug had a reduced risk of relapse compared to those who received placebo. There was no evidence of benefit in patients who were negative for the antibody. The most common adverse reactions were urinary tract infection, headache, arthralgia, nausea, and back pain. The prescribing information includes a warning about infusion reactions, potential depletion of certain proteins, and risk of infection.
Fenfluramine (Fintepla) for the treatment of seizures associated with Dravet syndrome. The drug, a Schedule IV controlled substance, was associated with greater reductions in the frequency of convulsive seizures compared with placebo in two clinical trials. A boxed warning states the orphan drug is associated with valvular heart disease and pulmonary arterial hypertension. The most common adverse reactions were decreased appetite, drowsiness, diarrhea, constipation, abnormal echocardiogram, fatigue, ataxia, balance disorder, increased blood pressure, drooling, pyrexia, upper respiratory tract infection, vomiting, decreased weight, risk of falls, and status epilepticus.
Capmatinib (Tabrecta) to treat adults with non-small-cell lung cancer that has spread to other parts of the body. The kinase inhibitor is the first therapy approved to treat this kind of cancer with mutations that lead to mesenchymal-epithelial transition exon 14 skipping. The FDA also approved a companion diagnostic, the FoundationOne CDx assay. In a trial of 28 patients who had never received treatment for non-small-cell lung cancer and 69 previously treated patients, the overall response rates to the orphan drug were 68% and 41%, respectively. Common side effects included peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Serious side effects include interstitial lung disease, hepatotoxicity, and pneumonitis.
First-time generic approvals
Posaconazole oral suspension (200 mg/5 mL [40 mg/mL]) for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, as well as for the treatment of oropharyngeal candidiasis. (Brand name: Noxafil)
Efavirenz, lamivudine, and tenofovir disoproxil fumarate tablets (600 mg/300 mg/300 mg and 400 mg/300 mg/300 mg) as a complete regimen for the treatment of HIV type 1 infection. (Brand names: SYMFI and SYMFI LO)
Tolvaptan tablets (15 mg, 30 mg, and 60 mg) for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. (Brand name: Samsca)
Icosapent ethyl capsules (1 g) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. (Brand name: Vascepa)
Esomeprazole magnesium delayed-release tablets (20 mg [base] over-the-counter) for the treatment of frequent heartburn occurring two or more days a week. (Brand name: Nexium 24HR)
Calcipotriene and betamethasone dipropionate topical suspension (0.005%/0.064%) for the topical treatment of plaque psoriasis of the scalp and body. (Brand name: Taclonex)
Desonide gel (0.05%) for the treatment of mild to moderate atopic dermatitis. (Brand name: Desonate)
Ursodiol capsules USP (200 mg and 400 mg) for the treatment and prevention of gallstones. (Brand name: Actigall)
Ivermectin lotion (0.5%) for the topical treatment of head lice infestations. (Brand name: Sklice)
Note: The FDA states that drugs are not always commercially available immediately after approval.