Recalls, warnings, and alerts
A warning that there has been a sharp increase in hand sanitizer products that have tested positive for methanol contamination. Methanol, or wood alcohol, can be toxic when absorbed through the skin and can be life-threatening when ingested. It is not an acceptable ingredient for hand sanitizers. The FDA is aware of adults and children ingesting hand sanitizer products contaminated with methanol, which has led to recent adverse events including blindness, hospitalizations, and death. In response to this issue, several types of hand sanitizer products have been recalled.
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.
A class I recall of the Arrow AutoCAT2 and AC3 Optimus Intra-Aortic Balloon Pump Series by Arrow International due to possible breakdown of motor connector wires. The recall includes 2,123 devices distributed from March 15, 2018, to May 1, 2020.
A class I recall of the GlideScope Core One TouchSmart Cable by Verathon Inc. due to partial or complete loss of image during use. The cable is used to connect the GlideScope Spectrum single-use video laryngoscope and GlideScope Video Baton 2.0 to video monitors. There have been 74 complaints and nine medical device reports, but no reported injuries or deaths, related to this issue.
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 the 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.
A recall of 12 lots of metformin hydrochloride extended-release tablets USP (750 mg in 100-and 500-count bottles) by Granules Pharmaceuticals Inc. due to the detection of excess levels of N-nitrosodimethylamine (NDMA) in one lot. In addition, Lupin Pharmaceuticals Inc. recalled all batches of metformin hydrochloride extended-release tablets USP (500 mg and 1,000 mg) due to detection of NDMA. All recalled products were distributed nationwide.
A recall of one lot of daptomycin for injection (500 mg/vial) by Mylan Institutional LLC due to the presence of particulate matter in one vial. The affected batch was distributed nationwide between April and May 2020.
A recall of two lots of dexmedetomidine hydrochloride in 0.9% sodium chloride injection (200 µg/50 mL [4 µg/mL], 50-mL fill in 50-mL vials) by Fresenius Kabi USA due to potential cross-contamination of lidocaine. The affected lots were distributed nationwide between June 3, 2019, and April 8, 2020.
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 newly discovered 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. :
A reissued emergency use authorization for the LabCorp COVID-19 RT-PCR Test, including two new indications for use of the test in people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, as well as to allow pooled sample testing. The FDA reissued the authorization after the company provided scientific data demonstrating the test's ability to detect SARS-CoV-2 in a general, asymptomatic population. In addition, the reissuance includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation.
A reissued emergency use authorization for the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR test. The test is now authorized for use with pooled samples containing up to four individual upper-respiratory swab specimens collected under observation.
Emergency use authorizations for two serology-based tests for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2. The BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test by Xiamen Biotime Biotechnology Co. Ltd. and the CareStart COVID-19 IgM/IgG by Access Bio Inc. are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Approval of an abbreviated new drug application, or generic, for heparin sodium. The approval came in response to increased demand for anticoagulants during the COVID-19 public health emergency.
A temporary policy for compounding of dexamethasone sodium phosphate by outsourcing facilities and pharmacy compounders. The industry guidance is intended to address shortages of certain drugs urgently needed for patients hospitalized with COVID-19.
An emergency use authorization for the GammaCore Sapphire Non-invasive Vagus Nerve Stimulator. The device is intended for use at home or in health care settings to treat adults with known or suspected COVID-19 who are experiencing worsened asthma-related shortness of breath and reduced airflow and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by the patient's clinician. It is placed on either side of the patient's neck for two consecutive two-minute stimulations at the onset of respiratory distress or shortness of breath, for up to 24 stimulations every 24 hours.
An emergency use authorization for the SleepWeaver Prevent CPAP Mask. The product is a continuous positive airway pressure (CPAP) mask that was modified for use during the pandemic by combining it with an N95 respirator.
A letter to clinical laboratory staff and clinicians alerting them of increased risk of a false-positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found about 3% of results to be false positive. The FDA is working with Becton, Dickinson and Company (BD) to resolve the issue.
An emergency use authorization for the CDC's Influenza SARS-CoV-2 Multiplex Assay. The test is the third to be authorized for detection and differentiation of the viruses that cause flu and COVID-19 in patients with suspected COVID-19. Such combination tests may be useful in preserving critical testing resources during the upcoming flu season, the FDA said.
An emergency use authorization for the BD Veritor System for Rapid Detection of SARS-CoV-2. The test, which was the second COVID-19 antigen test authorized by the FDA, can provide results in minutes but may not detect all active infections.
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.
A requirement for manufacturers to add new recommendations about naloxone to the prescribing information of all opioid pain relievers and medicines to treat opioid use disorder. The patient medication guides will also be updated. These changes are intended to help ensure that clinicians discuss the availability of naloxone, which can help reverse opioid overdose, and assess each patient's need for a naloxone prescription when prescribing or renewing opioid pain relievers or medicines to treat opioid use disorder, the FDA said. Clinicians should also consider prescribing naloxone when a patient has household members, including children, who are at risk for accidental ingestion or overdose, as well as when a patient is at increased overdose risk in the absence of a prescription for these medicines, the agency said.
Interim postmarket surveillance study results for the Essure birth control device. While the device has not been available for implantation in the U.S. since December 2019, the FDA is evaluating long-term safety information in women who have received it. Early results from an FDA-required postmarket surveillance study found that these women tend to have higher rates of chronic lower abdominal and/or pelvic pain, abnormal uterine bleeding, and gynecologic surgical procedures compared to women who had laparoscopic tubal ligation as their permanent birth control.
Fostemsavir (Rukobia), a new type of antiretroviral medication for HIV. The drug is indicated for adults who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. In a clinical trial of 371 participants, those who received the drug had a significantly greater decrease in levels of HIV RNA in their blood compared to those taking placebo. The most common adverse reaction was nausea, and severe adverse reactions included elevations in liver enzymes among participants also infected with hepatitis B or C virus and immune reconstitution syndrome.
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.
Decitabine and cedazuridine tablets (Inqovi) to treat adults with myelodysplastic syndromes and chronic myelomonocytic leukemia. The orphan drug is taken as one tablet by mouth once daily for five consecutive days of each 28-day cycle. Approval was based on clinical trial results, which showed similar drug concentrations and a similar safety profile between the drug and IV decitabine. Common side effects include fatigue, constipation, hemorrhage, muscle pain, mucositis, arthralgia, nausea, and fever with low white blood cell count.
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 pembrolizumab (Keytruda) for IV injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer. The medication, which targets the PD-1/PD-L1 pathway, is the first immunotherapy to be approved as a first-line treatment for this patient population without concomitant chemotherapy. It was previously approved to treat other types of cancer. Approval was based on the results of one randomized trial comparing pembrolizumab with chemotherapy in 307 patients, in which median progression-free survival was 16.5 months with the drug versus 8.2 months with standard care, although longer-term analysis is needed to assess for an effect on survival. Common side effects include fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, fever, cough, dyspnea, constipation, pain, and abdominal pain. The drug can also cause immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Patients who experience severe or life-threatening infusion-related reactions should stop taking the drug.
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 it 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.
Brexucabtagene autoleucel (Tecartus) to treat adults diagnosed with mantle-cell lymphoma who have not responded to or who have relapsed following other kinds of treatment. The chimeric antigen receptor T-cell therapy is the first cell-based gene therapy approved for the treatment of mantle-cell lymphoma. In a trial of 60 patients, the complete remission rate after treatment with the drug was 62%, with an objective response rate of 87%. Common side effects include serious infections, low blood cell counts, and a weakened immune system. The label carries a boxed warning for cytokine release syndrome.
Selpercatinib capsules (Retevmo) to treat patients with lung and thyroid cancers with a certain genetic alteration. The drug is approved to treat three types of tumors (non-small-cell lung cancer, medullary thyroid cancer, and other types of thyroid cancers) in patients whose tumors have a mutation or fusion in the rearranged during transfection (RET) gene. The kinase inhibitor is the first therapy approved specifically for cancer patients with the RET gene alterations. Approval was based on a trial of patients with each of the three types of tumors. The overall response rate ranged from 73% to 84%, with 58% to 75% of patients who responded to treatment having a response that lasted at least six months. The most common side effects include elevated liver enzymes, increased blood glucose levels, decreased white blood cell count, decreased albumin in the blood, decreased calcium in the blood, dry mouth, diarrhea, increased creatinine levels, increased alkaline phosphatase levels, hypertension, fatigue, swelling in the body or limbs, low blood platelet count, increased cholesterol levels, rash, constipation, and decreased sodium in the blood. The orphan drug can also cause serious side effects, such as hepatotoxicity, elevated blood pressure, QT prolongation, bleeding, and allergic reactions.
First-time generic approvals
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)
Pantoprazole sodium for delayed-release oral suspension (40 mg) for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease; for the maintenance of healing of erosive esophagitis; and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (Brand name: Protonix)
Meloxicam capsules (5 mg and 10 mg) for the management of osteoarthritis pain. (Brand name: Vivlodex)
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)
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)
Desonide gel (0.05%) for the treatment of mild to moderate atopic dermatitis. (Brand name: Desonate)
Tolvaptan tablets (15 mg, 30 mg, and 60 mg) for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. (Brand name: Samsca)
Ursodiol capsules USP (200 mg and 400 mg) for the treatment and prevention of gallstones. (Brand name: Actigall)
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)
Betamethasone dipropionate spray (0.05%) for the treatment of mild to moderate plaque psoriasis in adult patients. (Brand name: Sernivo)
Halobetasol propionate lotion (0.05%) for the topical treatment of plaque psoriasis in adult patients. (Brand name: Ultravate)
Note: The FDA states that drugs are not always commercially available immediately after approval