First device approved to treat congenital heart disease

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

Recalls, warnings, and alerts

A class I recall of the HeartWare Ventricular Assist Device Pump Implant Kit by Medtronic because the device may fail to initially start, restart, or have a delay in restarting after the pump is stopped. These delays or failures have occurred during preimplant testing, during the implant, and in a variety of postimplant situations. There have been 29 complaints about this device issue, which include 19 serious injuries and eight cases of patients who had a life-threatening event but recovered without long-term effects. Two deaths have been reported. One hundred fifty-seven recalled kits were distributed from Oct. 23, 2017, to April 30, 2020.

A class I recall of the Kodama Intravascular Ultrasound Catheter by ACIST Medical Systems because the O-ring housing tubing may squeeze and damage the O-ring, potentially leading pieces to break free and flush into the patient's artery during use. The recall includes 490 devices distributed from Nov. 10, 2020, to Jan. 14, 2021. No related complaints, injuries, or deaths have been reported.

A class I recall of convenience kits by Combat Medical because the needle in the blood pack may bend or disconnect from the blood bag. The recalled kits are used by military medical personnel to get and transfuse donor blood to patients on the battlefield. There have been four complaints about this device issue and no reports of injuries or deaths. The recall includes a total of 30,549 of the following kits: Valkyrie LTOWB Collection and Administration, Low Titer Type O FWB Transfusion Set and Low Titer Type O Donor Collection Set, and Fresh Whole Blood Transfusion Set and Fresh Whole Blood Donor Set. Recalled kits were distributed from July 1, 2019, to Nov. 30, 2020.

A warning that misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine (Benzedrex) can lead to serious harms, such as heart and mental health problems. Reports of individuals misusing the drug have increased in recent years, the FDA said. Some complications of misuse, including fast or abnormal heart rhythm, high blood pressure, and paranoia, can lead to hospitalization, disability, or death. The FDA is requesting that all manufacturers of OTC propylhexedrine nasal decongestant inhalers consider product design changes that support their safe use. The drug is safe and effective when used as directed, the agency said.

A recall of four lots of acyclovir sodium injection (50 mg/mL in 10-mL and 20-mL vials) to the hospital level by Zydus Pharmaceuticals Inc. due to several complaints of crystallization in vials. Recalled products were distributed nationwide to Cardinal Health, AmerisourceBergen Drug Corporation, and Morris & Dickson Company LLC. No related adverse events have been reported.

An expanded recall of the ChloraPrep 3-mL applicator by Becton, Dickinson and Company (BD) because the product's lid can fail and lead to microbial contamination when exposed to higher temperature and humidity. While the initial recall did not apply to the U.S., the expanded recall includes four types of applicators distributed in all U.S. states. The FDA advised health care professionals not to use ChloraPrep 3-mL applicators manufactured by BD due to these contamination risks and to use an available alternative.

A recall of three lots of phenylephrine hydrochloride injection USP (10 mg/mL) by Sagent Pharmaceuticals Inc. due to potentially loose crimped vial overseals. The product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals Inc., which initiated the recall due to a customer complaint. Recalled products were distributed nationwide to hospitals, wholesalers, and distributors from Nov. 17, 2020, to March 8, 2021.

A recall of 47 bottles of spironolactone tablets by Bryant Ranch Prepack due to mislabeling with the incorrect strength. Prepackaged bottles labeled as containing 50-mg spironolactone tablets may contain 25-mg spironolactone tablets and vice versa. No related adverse events have been reported.

A recall of one lot of telmisartan tablets USP (20 mg in 30-count bottles) by Alembic Pharmaceuticals due to a label mix-up. One complaint stated that a bottle labeled as 30-count telmisartan tablets USP (20 mg) incorrectly contained 30 tablets of telmisartan tablets USP (40 mg).

An alert about the risk of fracture of the plastic component of all Scandinavian Total Ankle Replacement (STAR Ankle) devices. The evidence suggests that this risk is increased most in patients with more active lifestyles, osteoarthritis, or age younger than 55 years. However, the STAR Ankle remains appropriate for certain patient populations, such as older patients with lower activity levels, the FDA said. The agency provided recommendations to help clinicians who treat and follow patients with a STAR Ankle, such as carefully following the instructions for use and discussing benefits and risks of all relevant treatment options for patients with painful arthritic ankle joints.

A recall of 26 lots of nonalcohol-based antimicrobial hand sanitizer by Sanit Technologies LLC (doing business as Durisan) due to microbial contamination. The products had out-of-specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic. Recalled products were manufactured from February through June 2020 and distributed to retailers nationwide.

A recall of all lots of hand sanitizer packaged in 9.6-fl oz containers by PNHC LLC (doing business as Heal the World) because the containers resemble small water bottles. Ingesting hand sanitizer could potentially result in alcohol toxicity. No complaints or adverse reactions have been reported.

COVID-19 updates

An emergency use authorization (EUA) for the Cue COVID-19 Test for Home and OTC Use. The molecular test can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone app, which provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.

An EUA for Propofol-Lipuro (1% injectable emulsion for infusion) to maintain sedation via continuous infusion in patients ages 16 years and older who require mechanical ventilation in an ICU setting during the COVID-19 public health emergency. The drug is not FDA approved and has important differences in its formulation compared to approved propofol drugs. Clinicians should consult the drug fact sheet for more information before administering this alternative, the FDA said.

An EUA for the first machine learning-based COVID-19 nondiagnostic screening device to identify certain biomarkers that may indicate infection. The Tiger Tech COVID Plus Monitor is an armband with embedded light sensors and a small computer processor. The sensors first obtain pulsatile signals from blood flow, then the processor extracts key features like pulse rate and feeds them into a probabilistic machine learning model that has been trained to make predictions about whether the individual is showing certain signals, such as hypercoagulation, a common abnormality in patients with COVID-19. The device is not a substitute for a COVID-19 diagnostic test and is not intended for use in individuals with symptoms of COVID-19. It is designed to be used following a temperature reading that does not meet criteria for fever in settings where temperature checks are being conducted in accordance with CDC and local guidelines.

An EUA for the T-Detect COVID Test. The test analyzes DNA from a patient's T cells to aid in identifying people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. The test should be used together with a clinical examination and patient history, and negative results do not rule out acute or current infection, the FDA said.

An EUA for the Quidel QuickVue At-Home COVID-19 Test. The antigen test is authorized for prescription home use with self-collected anterior nares swabs from individuals ages 14 years and older and those ages 8 years and older with swabs collected by an adult. The test is authorized for patients in whom a clinician suspects COVID-19 within the first six days of symptom onset.

Marketing of the first SARS-CoV-2 diagnostic test using the traditional premarket review process. The FDA granted marketing authorization for the BioFire Respiratory Panel 2.1, a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals with suspected COVID-19 and other respiratory tract infections. The diagnostic test, which had an EUA, was granted marketing authorization using the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

A letter to clinical laboratory staff, point-of-care staff, and clinicians alerting them that false-positive results can occur with the cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test for use on the cobas Liat System by Roche Molecular Systems Inc. The erroneous results may be related to two issues observed by the company: sporadic leakage of the assay tubes and abnormal polymerase chain reaction cycling in the reaction tubes. Test users should monitor for unexpected clusters of positive influenza B results, should repeat tests when two or three analytes are positive, and should discontinue use and contact the company if either of these two issues is suspected, the FDA said.

An alert that improper use of thermal imaging systems intended to measure human body temperature may provide inaccurate temperature readings due to a variety of factors. Inaccuracies are more likely to occur where thermal imaging systems scan multiple individuals simultaneously, the FDA said.

A consumer update explaining why ivermectin should not be used to treat or prevent COVID-19. The FDA has not approved the drug for this use; it is currently approved to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. Ivermectin is not an antiviral, and taking large doses is dangerous and can cause serious harms, such as nausea, vomiting, diarrhea, hypotension, allergic reactions, dizziness, ataxia, seizures, coma, and death, 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 azithromycin tablets USP (500 mg).


The first device to treat patients with congenital heart disease. The Harmony Transcatheter Pulmonary Valve is indicated to treat adult and pediatric patients with a native or surgically repaired right ventricle to the lungs. The device is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care. Use of the valve may delay the time before a patient needs additional open-heart surgery and can also potentially reduce the number of open-heart surgeries required over a patient's lifetime, the FDA said. Safety and effectiveness were assessed through a prospective, nonrandomized, multicenter study in which physicians implanted the device in 70 patients. The primary effectiveness end point was the percentage of patients with no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at six months. Among patients with available echocardiography data, 89.2% of them achieved this end point. The primary safety end point was no procedure- or device-related death within 30 days following the implant, which 100% of patients attained. Adverse events included irregular or abnormal heart rhythms (23.9%), leakage around the valve (8.5%), minor bleeding (7.0%), narrowing of the pulmonary valve (4.2%), and movement of the implant (4.2%). The device is contraindicated in patients with an infection in the heart or elsewhere, those who cannot tolerate blood-thinning medicines, and those who have sensitivity to titanium or nickel.

Marketing of a device to improve gait in patients with multiple sclerosis. The Portable Neuromodulation Stimulator device is indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis. It is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients ages 22 years and older. The neuromuscular tongue stimulator consists of a nonimplantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to provide treatment of motor deficits. The device consists of a controller and a mouthpiece that are connected to each other by a cord. The mouthpiece is held lightly in place by the lips and teeth, and the control unit is worn around the neck during a patient's visit with a physical therapist. Safety and effectiveness were assessed in two clinical studies and a retrospective analysis of real-world data. In the first randomized controlled trial of 20 patients, the group that received the device on average achieved a nearly eight-point improvement in Dynamic Gait Index score at the end of the study, whereas the group that received a sham control device did not. In the second randomized controlled trial of 14 patients, the group that received the device showed an improvement in sensory organization task scores at 14 weeks compared to baseline but no change in Dynamic Gait Index score. No serious safety adverse events were reported in the studies or in the analysis of real-world data. The device should not be used by patients with penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakers, or a history of seizures.

Marketing of the first robotically assisted surgical device for performing transvaginal hysterectomy. The Hominis Surgical System is intended for benign hysterectomy with salpingo-oophorectomy. To remove the uterus, the system uses minimally invasive surgical instruments inserted through the vagina and a video camera inserted laparoscopically through a small incision in the abdomen for visualization of the instruments inside the patient. In a clinical study of 30 patients using the system, all 30 procedures were successfully completed, and there were no conversions to an open or other laparoscopic surgical approach. Observed adverse events included minor blood loss, urinary tract infection, and delayed healing of the closure made at the top of the vagina.

First generic drug approvals

Droxidopa capsules (100 mg, 200 mg, and 300 mg) for the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension. (Brand name: Northera)

Linaclotide capsules (145 µg and 290 µg) for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation. (Brand name: Linzess)

Topiramate extended-release capsules (25 mg, 50 mg, 100 mg, 150 mg, and 200 mg) for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients ages 2 years and older; as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older; and for the preventive treatment of migraine in patients ages 12 years and older. (Brand name: Qudexy XR)

Apremilast tablets (10 mg, 20 mg, and 30 mg) for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. (Brand name: Otezla)

Loteprednol etabonate ophthalmic gel (0.5%) for the treatment of postoperative inflammation and pain following ocular surgery. (Brand name: Lotemax)

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