Recalls and warnings
A class I recall of Trevo XP ProVue Retrievers by Stryker Neurovascular due to a risk that the core wire may break or separate when it is retracted during use. There have been 11 related reports of injury or illness and one death. The recall includes 1,258 devices distributed from Sept. 18, 2019, to July 7, 2020.
A class I recall of Rashkind Balloon Septostomy Catheters by Medtronic due to quality issues that may lead to the device breaking, separating, or failing during use. There have been two related reports of injury and one death. The recall includes 142 devices distributed from May 28, 2018, to Aug. 28, 2020. In addition, the company has stopped manufacturing and distributing the catheters for reasons unrelated to this recall.
A class I recall of BD Alaris Pump Module and Pump Module Door Assembly Replacement Kits by Becton Dickinson CareFusion 303 Inc. due to the potential for stuck or unresponsive keys. There have been nearly 1,000 complaints about this issue but no reported injuries or deaths. The recall includes 264,746 devices distributed from Dec. 1, 2016, through Jan. 23, 2019.
A class I recall of fixed core wire guides by Cook Medical because five lots of wire guides dropped onto an unchecked surface during production, potentially causing them to bend out of shape or become dirty. There have been no related complaints or reported injuries or deaths. The recall includes 61 devices distributed on Sept. 9, 2020.
A warning that using NSAIDs in the second half of pregnancy could lead to complications. The FDA is requiring labeling changes that explain that the medications may cause rare but serious kidney problems in an unborn baby if women take them about 20 weeks or later in their pregnancy. These kidney problems can lead to low levels of amniotic fluid (i.e., oligohydramnios) and the potential for pregnancy-related complications. Oligohydramnios may be detected after taking NSAIDs for days, weeks, or as soon as two days after starting regular use, the FDA said, adding that the condition usually resolves if the pregnant woman stops taking the drug.
Approval of remdesivir (Veklury) to treat COVID-19 requiring hospitalization in patients ages 12 years and older and weighing at least 40 kg. The antiviral is the first drug approved to treat COVID-19. It should only be administered in a hospital or in a health care setting capable of providing comparable acute care. Approval was based on the FDA's analysis of data from three randomized controlled clinical trials in patients hospitalized with mild to severe COVID-19. The agency revised the drug's emergency use authorization (EUA) to remove these newly approved uses, leaving the EUA to cover hospitalized pediatric patients with suspected or confirmed COVID-19. Possible side effects of the drug include increased levels of liver enzymes, allergic reactions, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, and sweating or shivering.
An EUA for casirivimab and imdevimab, administered together by IV infusion, to treat certain patients with mild to moderate COVID-19. The monoclonal antibodies are indicated for patients ages 12 years and older weighing at least 40 kg who have a positive direct SARS-CoV-2 viral test and are at high risk for progressing to severe COVID-19 (including patients ages 65 years or older or who have certain chronic medical conditions). In a clinical trial, the treatment reduced COVID-19-related hospitalizations or ED visits in patients at high risk for disease progression within 28 days after treatment when compared with placebo. Casirivimab and imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
An EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in adult and pediatric patients. The investigational monoclonal antibody therapy is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are ages 12 years and older weighing at least 40 kg and who are at high risk for progressing to severe COVID-19 and/or hospitalization (including patients ages 65 years or older or who have certain chronic medical conditions). In a clinical trial, the treatment reduced COVID-19-related hospitalizations or ED visits in patients at high risk for disease progression within 28 days after treatment when compared with placebo. Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
An EUA for baricitinib, in combination with remdesivir, for the treatment of certain patients with suspected or laboratory-confirmed COVID-19. The drug combination is indicated for hospitalized adults and pediatric patients ages 2 years or older with confirmed or suspected COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. In a clinical trial, patients who received baricitinib and remdesivir had a shorter time to recovery after treatment initiation compared with those who received a placebo with remdesivir. Potential side effects include serious infections, blood clots, changes in certain lab test results, and allergic reactions. Baricitinib, a Janus kinase inhibitor, is not authorized or approved as a standalone treatment for COVID-19.
A reissued EUA for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high- and low-titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.
An EUA for the first COVID-19 diagnostic test that can be fully self-administered and provide rapid results at home. The Lucira COVID-19 All-In-One Test Kit is authorized for home use with self-collected nasal swab samples in patients ages 14 years and older in whom COVID-19 is suspected by their clinician. The molecular test, which provides results within 30 minutes, is currently authorized for prescription use only. It is also authorized for use in point-of-care settings for all ages, but samples must be collected by a clinician to test individuals younger than age 14 years.
An EUA for the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. The cPass SARS-CoV-2 Neutralization Antibody Detection Kit can detect these antibodies, which have been shown in a lab setting to decrease SARS-CoV-2 viral infection of cells. The effect of neutralizing antibodies for SARS-CoV-2 in humans is still being researched, and the FDA cautioned patients against using the results from this or other serology tests as an indication that they can stop taking steps to protect themselves and others (e.g., stopping social distancing, discontinuing wearing masks).
A letter to clinicians recommending that they provide clear, step-by-step instructions to patients who are self-collecting anterior nasal samples for SARS-CoV-2 testing in a health care setting. Instructions should include the following: placing the entire tip of the swab inside the nose and using moderate pressure and a large circular motion to rub the side of the swab tip against as much of the wall of the anterior nares region as possible; performing at least four of these sweeping circles in each nostril using the same swab for about 10 to 15 seconds per nostril; and avoiding twirling the swab against one part of the inside of the nose or simply leaving the swab in the nose. Without proper instructions, patients may not collect an adequate sample for testing, potentially decreasing the sensitivity of the test, the FDA said.
An alert that false-positive results can occur with antigen tests for the rapid detection of SARS-CoV-2. The FDA is aware of reports of false positives associated with antigen tests used in nursing homes and other settings and continues to monitor and evaluate these reports. Clinicians and clinical lab staff can help ensure accurate reporting of test results by following the authorized instructions for use of a test and key steps in the testing process as recommended by the CDC, including routine follow-up testing with a molecular assay when appropriate and considering the expected occurrence of false-positive results when interpreting test results in their patient populations, the FDA said.
Guidance on the use of dry heat to help support the single-user reuse of certain particulate-filtering facepiece respirators (e.g., N95 respirators). Such bioburden reduction systems are intended to achieve a certain level of microbial reduction on a device when there is a limited supply of respirators during the COVID-19 public health emergency; they are not decontamination systems. Clinicians should only use these systems in conjunction with CDC recommendations for particulate-filtering facepiece respirator reuse, the FDA said.
Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include dexmedetomidine hydrochloride in 0.9% sodium chloride injection, succinylcholine chloride injection USP (200 mg/10 mL), and cisatracurium besylate USP (10 mg/5 mL and 200 mg/20 mL).
A reissued EUA for certain filtering facepiece respirators that are manufactured in China and are not approved by the CDC's National Institute for Occupational Safety and Health. The reissued authorization no longer includes the three eligibility criteria that were included in the previous authorization letter, meaning the FDA will no longer review requests and add new respirator models to the list of authorized respirators based on those criteria. Authorization of respirator models that were already included on that list will continue.
An urgent device correction for all Sigma Spectrum Infusion Pumps by Baxter International Inc. because deviations from the specified cleaning methods may impair infusion pump functionality and performance. To date, the company has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion. Among other actions to reinforce safety information regarding cleaning practices, the company will clarify the instructions for use to recommend a routine inspection to identify signs of residue buildup, corrosion, and depressed pins.
An expanded indication for baloxavir marboxil (Xofluza) to include postexposure prevention of influenza for patients ages 12 years and older after contact with an individual who has the flu. The drug, previously available only in tablet form, is also now available as granules for mixing in water. It was originally approved in 2018 for treating uncomplicated flu in patients ages 12 years and older who have been symptomatic for no more than 48 hours. A randomized, placebo-controlled trial evaluated its safety and efficacy for postexposure flu prevention. Overall, 1% of participants who received the drug had infection, fever, and at least one respiratory symptom from day 1 to day 10, compared with 13% of those who received a placebo. The most common side effects include diarrhea, bronchitis, nausea, sinusitis, and headache. Hypersensitivity reactions, including anaphylaxis, can also occur. The drug should not be co-administered with dairy products; calcium-fortified beverages; or laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminum, or zinc.
Marketing of a device intended for the temporary reduction of sleep disturbance related to nightmares. The device, called Nightware, is indicated for adults ages 22 years and older who have nightmare disorder or nightmares from post-traumatic stress disorder (PTSD). It is available by prescription only and is intended for home use. Using a smartwatch and a smartphone that are configured and logged into a software application and the Nightware server, the device provides gentle vibration through touch based on an analysis of heart rate and motion during sleep. It should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, according to relevant consensus guidelines, the FDA said.
Gallium 68 PSMA-11 as the first drug for positron emission tomography imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. The radioactive diagnostic agent, which is administered by IV injection, is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. The drug is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen levels. In two prospective clinical trials of men who each received one injection, no serious adverse reactions were reported. The most common adverse reactions to the drug were nausea, diarrhea, and dizziness. In addition, the drug contributes to a patient's cumulative radiation exposure.
Atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb) to treat Zaire ebolavirus, or Ebola virus, infection in adult and pediatric patients. The mixture of three monoclonal antibodies, which is the first FDA-approved treatment for Ebola virus, targets the glycoprotein that is on the surface of the virus. In a clinical trial of adult and pediatric patients with confirmed Ebola virus infection, 33.8% of 154 patients who received the drug died after 28 days, compared with 51% of 153 patients who received an investigational control. The most common side effects include fever, chills, tachycardia, tachypnea, and vomiting. Patients who receive the orphan drug should avoid the concurrent administration of a live vaccine due to the potential for reduced efficacy.
Nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adults with malignant, unresectable pleural mesothelioma. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma. In a trial of 605 patients, those who received the drug combination survived a median of 18.1 months, and those who underwent chemotherapy survived a median of 14.1 months. The most common side effects include fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus. The drug can also cause immune-mediated side effects.
First-time generic approvals
Levothyroxine sodium capsules (75 µg and 150 µg) for patients ages 6 years and older with hypothyroidism and pituitary thyrotropin suppression. (Brand name: Tirosint)
Fosfomycin tromethamine granules for oral solution (3 g [base] in single-dose packets) for the treatment of uncomplicated urinary tract infections in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. (Brand name: Monurol)
Pomalidomide capsules (1 mg, 2 mg, 3 mg, and 4 mg), in combination with dexamethasone, for the treatment of certain adult patients with multiple myeloma, of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy, and of patients with KS who are HIV negative. (Brand name: Pomalyst)
Potassium chloride in 0.45% and 0.9% sodium chloride injection USP as a source of water and electrolytes and 5% dextrose injection USP as a source of water, electrolytes, and calories. (Brand names: None provided)
Potassium chloride injection for the treatment of potassium deficiency states when oral replacement is not feasible. (Brand name: None provided)
Cyanocobalamin nasal spray (500 µg per spray) for the maintenance of normal hematologic status in patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement. (Brand name: Nascobal)
Icosapent ethyl capsules (1 g) as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, or triglyceride levels greater than or equal to 500 mg/dL. (Brand name: Vascepa)
Sorafenib tablets (200 mg) for the treatment of unresectable hepatocellular carcinoma; advanced renal=cell carcinoma; and locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. (Brand name: Nexavar)
Lapatinib tablets (250 mg) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab and for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. (Brand name: Tykerb)
Note: The FDA states that drugs are not always commercially available immediately after approval.