FDA plans to ban menthol cigarettes, flavored cigars

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

Recalls and alerts

A class I recall of HeartWare HVAD battery cables, data cables, adapter cables and Controller 2.0 Ports by Medtronic due to risk of damage to controller ports. Wear and tear of the connector plugs could cause damage to metal pins in the controller port. There have been 855 related complaints and eight reports of injuries. Twelve deaths have been reported. A total of 106,366 recalled device parts were distributed from Oct. 9, 2006, to the present.

A class I recall of the Valiant Navion Thoracic Stent Graft System by Medtronic due to stent fractures and endoleak concerns. Following device implantation, patients may experience stent ring enlargement beyond design specification, stent fractures, holes in the graft fabric (type III endoleaks), life-threatening bleeding, aortic rupture, or death. There have been 11 related reports about this issue, including two injuries and one death. There have been four cases of type III endoleaks, four cases of stent fracture, and seven cases of stent ring enlargement. A total of 14,237 recalled devices were distributed from Nov. 12, 2018, to Feb. 10, 2021.

A class I recall of the Bio-Console 560 extracorporeal blood pumping console by Medtronic Perfusion Systems due to possible electrical failure causing the pump to stop. Other issues observed by users include the interface going blank, smoke coming from the device, and a burning odor during use. There have been nine related complaints, including three injuries. No deaths have been reported. A total of 93 devices were distributed from April 1, 2019, to Feb. 12, 2021.

A class I recall of the Precise PRO Rx US Carotid System by Cordis Corporation due to risk of device separation during use. There have been seven complaints about this issue, including five reported injuries. No deaths have been reported. A total of 7,300 recalled devices were distributed from Dec. 6, 2019, to Feb. 8, 2021.

A class I recall of the Alaris Pump Module Model 8100 by CareFusion 303 due to risk of stuck or unresponsive keys. The keypad may lift up due to fluid entry, leading keys to become unresponsive or stuck. There have been 79 related complaints but no reported injuries or deaths. A total of 145,492 recalled pump modules were distributed from Jan. 23 to Dec. 5, 2019.

A class I recall of the Alaris Infusion Pump bezel assembly and Alaris pumps repaired with the bezel assembly by Tenacore due to possible cracked or separated bezel repair posts. There have been two related complaints but no reported injuries or deaths. A total of 474 recalled devices were distributed from July 10, 2020, to Feb. 18, 2021. The company also recalled 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. In addition, there was a separate class I recall of the Alaris Infusion Pump Module 8100 bezel by Pacific Medical Group due to the same issue with possible cracked or separated bezel repair posts. There were 62 related complaints but no reported injuries or deaths.

A class I recall of ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets by Smisson-Cartledge Biomedical due to risk of patient exposure to aluminum. A part of the set, the cassette, which warms fluids directly with an aluminum plate, may leak aluminum into the fluids and expose patients to high levels of the metal. The recall is specific to this disposable cassette, not to the full pump. No related complaints have been reported. A total of 38,786 recalled device parts were distributed from 2006 to the present.

A recall of certain implantable cardioverter defibrillators and cardiac resynchronization therapy devices by Medtronic due to an unexpected and rapid decrease in battery life. The decrease in battery life is caused by a short circuit and will cause some devices to produce a low-battery warning earlier than expected. The recall includes the Evera, Viva, Brava, Claria, Amplia, Compia, and Visia devices. There have been 444 complaints and 264 medical device reports, with 18 injuries, including people experiencing bradycardia or heart failure symptoms. No deaths have been reported. A total of 239,171 recalled devices were distributed from Aug. 31, 2012, to May 9, 2018.

A recall of 198,350 bottles of acetaminophen extra-strength tablets (500 mg in 100-count bottles) by A-S Medication Solutions due to incorrect labeling. Recalled products were contained in health essentials kits distributed by Humana to its members and contain an incomplete prescription drug label rather than the required over-the-counter (OTC) drug facts label.

An alert that studies have shown a potential increased risk of arrhythmias in patients with heart disease who are taking lamotrigine (Lamictal). The FDA required these studies to further investigate the seizure and mental health drug's effects on the heart after receiving reports of abnormal electrocardiographic findings and other serious problems, including chest pain, loss of consciousness, and cardiac arrest. The FDA first added information about this risk to the lamotrigine prescribing information and medication guides in October 2020. Clinicians should assess whether the potential benefits of the medication outweigh the potential risk of arrhythmias for each patient, the FDA said. The agency is also requiring safety studies to evaluate whether other medicines in the same drug class have similar effects on the heart.


An announcement that the FDA is working toward banning menthol cigarettes within the next year. The agency plans to issue proposed product standards to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars. The decision is based on the evidence establishing the addictiveness and harm of these products and builds on previous actions that banned other flavored cigarettes in 2009.

An announcement that the FDA is investigating reports of patient infections and other possible contamination issues associated with reprocessing urological endoscopes. From Jan. 1, 2017, through Feb. 20, 2021, the FDA received more than 450 medical device reports describing postprocedure patient infections and other possible contamination issues associated with reprocessing these devices. In reports that provided the name of the device manufacturer, either Olympus Corporation or Karl Storz were cited. Clinicians should follow reprocessing instructions, avoid using a device that has failed a leak test, develop schedules for routine device inspection and maintenance, and discuss with patients the potential benefits and risks associated with procedures involving reprocessed urological endoscopes, the FDA said.

COVID-19 updates

A recommendation that health care personnel and facilities transition away from crisis-capacity conservation strategies. Based on the increased supply of new respirators approved by the CDC's National Institute for Occupational Safety and Health (NIOSH) that are currently available, the FDA and CDC believe there is an adequate supply of respirators to transition away from use of decontamination and bioburden-reduction systems. The FDA recommended that health care personnel and facilities limit decontamination of disposable respirators and increase inventory of available NIOSH-approved respirators, including N95s and other filtering facepiece respirators.

Two revisions to the EUA for the Moderna COVID-19 vaccine regarding the number of doses per vial available. The first revision clarified the number of doses per vial for the vials that are currently available, a maximum number of 11 extractable doses, with a range of 10 to 11 doses. The second revision authorized the availability of an additional multidose vial containing a maximum of 15 extractable doses, with a range of 13 to 15 doses.

Authorization of several COVID-19 tests for screening asymptomatic individuals. The tests use serial screening, or testing of asymptomatic individuals multiple times on a routine basis. Authorized tests include the Quidel QuickVue At-Home OTC COVID-19 test for OTC, at-home serial screening, multiple configurations of the Abbott BinaxNOW for serial screening at home or at the point of care without a prescription, and the BD Veritor System for Rapid Detection of SARS-CoV-2 for point-of-care serial screening with a prescription. While these tests were previously authorized to test those with COVID-19 symptoms, the new authorization allows testing of asymptomatic individuals when used for serial testing.

An EUA for the SARS-CoV-2 NGS Assay. The test uses next-generation sequencing to identify virus RNA from respiratory samples, such as nose or throat swabs and washes, from people with suspected COVID-19. It is the second whole-genome-sequencing diagnostic test for the qualitative detection of SARS-CoV-2 RNA to be authorized by the FDA.

An EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System. The test is the first antibody test authorized for use with home-collected dried blood samples. It is authorized for prescription use with a fingerstick dried blood sample that is self-collected by an individual age 18 years or older or collected by an adult from an individual age 5 years or older. Samples are collected at home, then sent to a Symbiotica Inc. laboratory for analysis.

Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include succinylcholine chloride injection USP (200 mg/10 mL).


A higher dosage of naloxone hydrochloride nasal spray to treat opioid overdose. The newly approved product delivers 8 mg of naloxone into the nasal cavity, whereas previously approved products delivered 2 mg and 4 mg of naloxone.

Use of a point-of-care chlamydia and gonorrhea test. The Binx Health IO CT/NG Assay can now be used in physician offices, community-based clinics, urgent care settings, outpatient health care facilities, and other point-of-care settings operating under a Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate of waiver, compliance, or accreditation. The test, which uses female vaginal swabs and male urine specimens, is performed while the patient is present and provides an actionable result in about 30 minutes. Performance of the test was evaluated in female patients ages 16 years and older and in male patients ages 17 years and older and was comparable to tests performed in a CLIA-certified laboratory that meets the requirements for high- or moderate-complexity testing.

Dostarlimab (Jemperli) to treat patients with endometrial cancer with a specific biomarker. The drug is indicated for those with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers are mismatch repair deficient (dMMR), as determined by an FDA-approved test. About 25% to 30% of patients with advanced endometrial cancer have dMMR tumors, according to the FDA. Safety and efficacy of the drug, which targets the PD-1/PD-L1 pathway, were studied in a single-arm trial. Of the 71 patients with dMMR recurrent or advanced endometrial cancer who received the drug, about 42% had a complete or partial response. For 93% of responders, the response lasted for six months or more. Common side effects include fatigue, nausea, diarrhea, anemia, and constipation. The drug can also cause immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

A new indication for nivolumab (Opdivo) in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. The drug is the first FDA-approved immunotherapy for first-line treatment of gastric cancer. It is also approved to treat certain patients with several types of cancer, including melanoma and esophageal squamous-cell carcinoma. Efficacy of the monoclonal antibody for the new indication was evaluated in a multicenter randomized open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. Median survival was 13.8 months for the 789 patients who received the drug plus chemotherapy compared to 11.6 months for the 792 patients who received chemotherapy alone. The most common side effects include peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain. The drug can also cause immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

Marketing of the first device that uses artificial intelligence (AI) based on machine learning to help clinicians detect lesions, such as polyps or suspected tumors, during colon cancer screening and surveillance. The GI Genius is designed to be compatible with many FDA-cleared standard video endoscopy systems and is composed of software that uses AI algorithm techniques to identify regions of interest in the colon. During a colonoscopy, the system generates markers and superimposes them on the video from the endoscope camera when it identifies a potential lesion. These signs signal to the clinician that further assessment may be needed, such as a closer visual inspection, tissue sampling, testing or removal, or ablation of the lesion. Safety and effectiveness were assessed in a multicenter randomized controlled study in Italy with 700 participants ages 40 to 80 years who were undergoing colonoscopy. The primary analyses from the study were based on a subgroup of 263 participants who were being screened or surveilled every three years or more. They received white light standard colonoscopy with the GI Genius (136 patients) or standard white light colonoscopy alone (127 patients). Colonoscopy plus the system was able to identify lab-confirmed adenomas or carcinomas in about 55% of patients compared to 42% of patients with standard colonoscopy, a difference of 13%. Use of the device led to more biopsies, but no additional adverse events were reported; however, there was a slight increase in the number of lesions biopsied that were not adenomas. The system is not intended to characterize or classify a lesion or to replace lab sampling as a means of diagnosis, the FDA said. It only identifies regions of the colon within the endoscope's field of view where a colorectal polyp might be located, allowing for a more extended examination during colonoscopy. It is up to the clinician to decide whether the identified region actually contains a suspected lesion and how the lesion should be managed, the FDA said.

First generic drug approvals

Hydrocodone bitartrate extended-release tablets (20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (Brand name: Hysingla ER)

Ibrutinib capsules (70 mg and 140 mg) for the treatment of adult patients with mantle-cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenström's macroglobulinemia, marginal zone lymphoma, or chronic graft-versus-host disease. (Brand name: Imbruvica)

Atropine sulfate injection USP (8 mg/20 mL [0.4 mg/mL] in multiple-dose vials) for the temporary blockade of severe or life-threatening muscarinic effects. (Brand name: None provided)

Dextrose injection (50%) USP (25 g/50 mL [0.5 g/mL] in single-dose prefilled syringes) for the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels and, after dilution, for IV infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. (Brand name: None provided)

Isotretinoin capsules USP (10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg) for the treatment of severe recalcitrant nodular acne in nonpregnant patients ages 12 years and older with multiple inflammatory nodules with a diameter of 5 mm or greater. (Brand name: Absorica)

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