FDA OKs marketing of devices for snoring, brain protection

This column reviews details on recent recalls, warnings, and approvals.

Recalls and alerts

A class I recall of the JET 7 Reperfusion Catheter with Xtra Flex Technology by Penumbra due to the potential for device malfunctions and the risk of unexpected death or serious injury when used for removing clots in stroke patients. The FDA has received more than 200 medical device reports associated with the catheter, including 14 patient deaths, as well as serious injuries including vessel damage, hemorrhage, and cerebral infarction. Device malfunctions include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip. The recall includes 22,656 devices distributed from June 17, 2019, to Dec. 14, 2020. The recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.

A class I recall of the Liko Multirall 200 Overhead Lift by Hillrom due to customer reports that the strap lock does not attach to the carriage hook as it should. There have been 34 complaints about this device issue and 22 reports of serious injuries. Two deaths have been reported. Recalled devices were distributed from Dec. 17, 2000, to Oct. 1, 2020.

A class I recall of the EMBLEM S-ICD (subcutaneous implantable cardioverter defibrillator) system by Boston Scientific due to risk of short-circuit. A manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high-voltage shocks. The company has received six complaints about this issue. There have been no reports of injuries or deaths. A total of 2,825 recalled devices were distributed from June 1, 2015, to Sept. 30, 2019.

COVID-19 updates

An emergency use authorization (EUA) allowing the Janssen (Johnson & Johnson) COVID-19 Vaccine to be distributed in the U.S. to individuals ages 18 years and older. The vaccine is the third to be authorized for the prevention of COVID-19. Safety and effectiveness data to support the EUA include analyses of about 40,000 participants enrolled in an ongoing, randomized, placebo-controlled international study. The vaccine was about 67% and 77% effective in preventing moderate to severe COVID-19 and severe/critical COVID-19, respectively, occurring at least 14 days after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea.

An EUA for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19. The drug combination is indicated for outpatients ages 12 years and older weighing at least 40 kg who test positive for the virus and are at high risk for progressing to severe COVID-19 and/or hospitalization. In a clinical trial, a single IV infusion of the medications significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo. The safety and effectiveness of the investigational therapy for use in the treatment of COVID-19 continue to be evaluated.

An alternative temperature for transporting and temporarily storing frozen vials of the Pfizer-BioNTech COVID-19 vaccine. The preferred storage of the undiluted vials is still in an ultra low-temperature freezer between −112°F and −76°F. However, the manufacturer submitted data to the FDA to support keeping the vaccine at temperatures commonly found in pharmaceutical freezers for transportation and storage for a period of up to two weeks. The alternative temperature is not applicable to the storage of thawed vials before dilution (in the refrigerator for up to five days) or to the storage of thawed vials after dilution (at refrigerator or room temperature for six hours).

An alert to health care professionals and compounders about the potential risks associated with compounding remdesivir drug products. The FDA cautioned against compounding remdesivir drug products and recommended that clinicians only utilize the FDA-approved drug for patients who are prescribed remdesivir. No compounded drugs are FDA-approved, and they should only be used in patients whose medical needs cannot be met by an FDA-approved drug, the agency said.

A letter to clinicians on using ventilator splitters during the COVID-19 pandemic. The letter provides up-to-date information regarding multiplexing ventilator tubing connectors, also known as ventilator splitters, when no alternatives for invasive ventilatory support are available. It includes descriptions of features that may help reduce certain risks associated with the use of ventilator splitters, considerations for clinicians and facilities when using ventilator splitters, and instructions for reporting problems with a device to the FDA.

Revised guidance to reflect a reissued EUA for COVID-19 convalescent plasma. The reissued EUA limits the authorization to the use of high-titer plasma for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and who cannot produce an adequate antibody response, as data indicate that plasma with low levels of antibodies may not be effective in treating COVID-19. The guidance provides recommendations to blood establishments on the collection and labeling of high-titer COVID-19 convalescent plasma under the EUA. In addition, the revisions address when individuals who have received an investigational COVID-19 monoclonal therapy as a participant in a clinical trial or those who have received an authorized or licensed COVID-19 monoclonal antibody therapy qualify as convalescent plasma donors.

A safety communication informing clinicians and patients about the limitations of pulse oximeters. While the devices are useful for estimating blood oxygen levels in patients with COVID-19 who monitor their condition at home, they have a risk of inaccuracy under certain circumstances that should be considered. For example, a recent report suggested that pulse oximeters may be less accurate in people with dark skin pigmentation, the FDA said.

An update from the FDA and the U.S. Department of Agriculture underscoring that there is no credible evidence of food or food packaging associated with or as a likely source of SARS-CoV-2 transmission. Based on currently available scientific information and international scientific consensus, the foods that consumers eat and the food packaging they touch are highly unlikely to spread the virus, the agencies said.

Policies to guide medical product developers addressing virus variants. The guidance focuses on vaccines and diagnostic and therapeutic products to address the emergence and potential future emergence of variants of SARS-CoV-2.

Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include piperacillin and tazobactam for injection and furosemide injection.


Trilaciclib (Cosela) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small-cell lung cancer. The drug, the first therapy in its class, inhibits cyclin-dependent kinase 4/6. Effectiveness was assessed in three randomized, double-blind, placebo-controlled studies in a total of 245 patients with extensive-stage small-cell lung cancer. In all three studies, those who received the drug had a lower chance of having severe neutropenia compared to those who received placebo. Of patients who had severe neutropenia, those who received the drug, on average, had severe neutropenia for a shorter time than those who received placebo. The most common side effects include fatigue; low levels of calcium, potassium, and phosphate; increased levels of aspartate aminotransferase; headache; and pneumonia. Patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

Lisocabtagene maraleucel (Breyanzi) to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. The chimeric antigen receptor T-cell therapy is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma. Safety and efficacy were assessed in a multicenter clinical trial of more than 250 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate after treatment was 54%. The labeling carries a boxed warning for cytokine release syndrome. Other side effects include hypersensitivity reactions, serious infections, low blood cell counts, and a weakened immune system.

Marketing of a prescription-only device intended to reduce snoring and mild obstructive sleep apnea. The eXciteOSA device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue. The mouthpiece has four electrodes, two located above the tongue and two located below the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state for a period of six weeks and once a week thereafter. Unlike devices used when patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep. Safety and effectiveness were assessed in 115 patients with snoring who used the device for six weeks and then discontinued use for two weeks before they were reassessed. Overall, the percent of time spent snoring at levels louder than 40 dB decreased by more than 20% in 87 patients (76%). In a subgroup of 48 patients with snoring and mild obstructive sleep apnea, the average Apnea-Hypopnea Index decreased by 48%, from 10.21 to 5.27, in 41 out of 48 patients (85%). The most common adverse events were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw. The device is contraindicated in patients with pacemakers or implanted pacing leads; patients with temporary or permanent implants, dental braces, intraoral metal prosthesis, restorations, or appliances or dental jewelry in the mouth; patients who are pregnant or may be pregnant; and patients suffering from ulcerations in or around the mouth. Patients should receive a comprehensive dental examination prior to using the device.

The Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. The spacer is the first implant to replace the talus for the treatment of avascular necrosis of the ankle joint. The implant is a joint-sparing alternative to other surgical interventions commonly used in late-stage avascular necrosis that may disable motion of the ankle joint. It is made for each patient individually, modeled from CT imaging, and fitted to a patient's specific anatomy. During the replacement surgery, the talus bone is removed and replaced with the implant, which is made from cobalt chromium alloy. Data supporting safety and probable benefit include results from 31 patients and 32 talus replacement surgeries (one patient had operations on both ankles) with the implant. The average reported pain decreased from moderate to severe prior to surgery to mild three years after the operation, and average range of motion in the ankle joint also improved. At three years, there were three reported additional surgeries. The most commonly reported adverse events were pain and scar tissue at the surgical site.

Marketing of a noninvasive device intended to help protect athletes' brains during head impacts. The device, called Q-Collar, is a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space. It is indicated for athletes ages 13 years and older who have been medically cleared to play contact sports. Safety and effectiveness were assessed in several studies, including a longitudinal study in the U.S. with 284 participants on a high school football team. During the sports season, 139 athletes wore the Q-Collar and 145 athletes did not, and each wore an accelerometer to measure impacts to the head during play. All underwent an MRI scan preseason and postseason. One hundred six of 146 (73%) participants who didn't wear the collar had significant changes in deeper tissues of the brain involved in the transmission of electrical nerve signals. In contrast, 107 of 139 (77%) who wore the collar had no significant changes in these regions of the brain. No significant adverse events were associated with device use. The collar does not replace, and should be worn with, other protective sports equipment, the FDA said. It can be worn for up to four hours at a time and should be replaced after two years of active use or the product's expiration date, whichever comes first.

First generic drug approvals

Levothyroxine sodium capsules (88 µg, 100 µg, and 125 µg) for patients ages 6 years and older with hypothyroidism. (Brand name: Tirosint)

Argatroban injection (50 mg/50 mL [1 mg/mL in single-dose vials]) for the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia and as an anticoagulant in adult patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention. (Brand name: None provided)

Epoprostenol for injection (0.5 mg/vial and 1.5 mg/vial) for the treatment of pulmonary arterial hypertension (World Health Organization Group 1) to improve exercise capacity. (Brand name: Veletri)

Ferumoxytol injection (510 mg iron/17 mL [30 mg/mL] in single-dose vials) for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron, who have had unsatisfactory response to oral iron, or who have chronic kidney disease. (Brand name: Feraheme)

Imiquimod cream USP (3.75%) for the topical treatment of clinically typical, visible, or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults and for the topical treatment of external genital and perianal warts/condyloma acuminata in patients ages 12 years and older. (Brand name: Zyclara)

Note: The FDA states that drugs are not always commercially available immediately after approval.