New category of OTC hearing aids; FMT and monkeypox

This column reviews recent recalls, alerts, and approvals.

Recalls and alerts

A safety alert advising that clinical use of fecal microbiota transplantation (FMT) has the potential to transmit monkeypox virus. Because of this risk, the FDA determined that additional protections are required for any investigational use of FMT if it involves stool donated on or after March 15, 2022. These additional protections include donor screening with questions aimed at identifying donors at high risk for monkeypox or those who may be currently or recently infected. As for blood donation establishments, the FDA does not recommend that they ask donors additional, specific questions about possible exposure to monkeypox virus, given the robustness of the existing safeguards for blood safety.

A class I recall of the CereLink ICP Monitor by Integra because the device may display incorrect values for a patient's intracranial pressure and display out-of-range pressure readings. There have been reports of associated patient injury and one associated patient death. The recall includes 388 devices distributed from June 1, 2021, to May 31, 2022.

A class I recall of Palindrome and Mahurkar Hemodialysis Catheters by Covidien LLC (Medtronic) due to a catheter hub defect that will connect both extension catheters, potentially leading to unanticipated fluid leaks. No associated injuries or deaths have been reported. The recall includes more than 1 million devices distributed from June 28, 2017, to May 11, 2022.

A safety communication alerting clinicians, patients, and caregivers about cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection. The FDA has received reports that using an autoinjector that is not compatible with the patient's specific glatiramer acetate injection drug product has resulted in missed and partial doses. The agency recommended that users confirm the autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product.

A class I recall of the Intera 3000 Hepatic Artery Infusion Pump by Intera Oncology after reports from clinicians that the pumps were delivering medications faster than expected. No associated injuries or deaths have been reported. The recall includes 50 devices distributed from Aug. 12, 2021, to May 17, 2022.

A class I recall of Cobalt CT, Cobalt, and Crome Implantable Cardioverter Defibrillators and Resynchronization Therapy Defibrillators by Medtronic after reports of devices with a short-circuit protection alert resulting in reduced-energy electric shock delivery during high-voltage therapy. No associated injuries or deaths have been reported. The recall includes 87,709 devices distributed since Feb. 3, 2020.

A class I recall of the Hamilton-C6 Intensive Care Ventilator by Hamilton Medical AG after customer complaints revealed a hardware issue with the ventilator's status indicator board. The board may become loose, allowing liquid to enter between the indicator board and the ventilator's main board, potentially causing a technical fault and causing the ventilator to revert to a safety mode or ambient state. No associated injuries or deaths have been reported. The recall includes 497 devices distributed from Aug. 31, 2017, to May 20, 2022.

A class I recall of HeartWare HVAD System batteries by Medtronic because the batteries may experience electrical faults that cause them to unexpectedly fail. The company has received reports of six associated injuries and one death. The recall includes 23,372 batteries distributed since Jan. 1, 2009.


A final rule establishing a new category of over-the-counter (OTC) hearing aids. The rule will take effect in mid-October, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, a prescription, or a fitting adjustment by an audiologist. The OTC category applies to certain air-conduction hearing aids intended for those ages 18 years and older who have perceived mild to moderate hearing impairment; hearing aids that do not meet these requirements are prescription devices. The rule is expected to lower the cost of hearing aids, the FDA noted.

COVID-19 updates

Amended emergency use authorizations for the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize their bivalent formulations for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, also called “updated boosters,” contain two messenger RNA components of SARS-CoV-2, one of the original strain of the virus and one in common between the BA.4 and BA.5 lineages of the omicron variant. Based on the data supporting each authorization, the FDA said it expects the updated boosters to provide increased protection against the currently circulating omicron variant. The updated Moderna booster is authorized in individuals ages 18 years and older, while the updated Pfizer-BioNTech booster is authorized in individuals ages 12 years and older.

A class I recall of Viral Transport Media Containers by Haimen Shengbang Laboratory Equipment Co. Ltd. because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The products are used to collect specimens for transport to a laboratory for viral testing to detect infection, including testing for SARS-CoV-2. No injuries or deaths have been associated with the recall, which includes more than 4 million products distributed from Oct. 8, 2021, to Feb. 15, 2022.

A class I recall of the Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits by North American Diagnostics because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. No injuries or deaths have been associated with the recall, which includes 122,175 tests distributed from March 1, 2021, to Feb. 15, 2022.

Recommendations for use of at-home COVID-19 antigen tests to reduce the risk of false-negative results. People should perform serial testing following a negative result on any at-home COVID-19 antigen test to reduce the risk of a false-negative result, the FDA said. The agency recommends repeat testing following a negative result, irrespective of COVID-19 symptoms. It is not necessary to use the same brand of test each time for repeat testing.


Fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with unresectable or metastatic non-small-cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC. In a randomized trial, those who received the drug by IV infusion had a confirmed objective response rate of 58% and a median duration of response of 8.7 months. The most common adverse reactions were nausea, decreased white blood cell count, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, decreased platelet count, decreased albumin, increased aspartate aminotransferase, increased alanine aminotransferase, fatigue, constipation, decreased appetite, vomiting, increased alkaline phosphatase, and alopecia. A boxed warning advises about the risks of interstitial lung disease and embryo-fetal toxicity.

Betibeglogene autotemcel (Zynteglo), the first cell-based gene therapy to treat adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. It is a one-time gene therapy product administered as a single dose, customized by using the patient's bone marrow stem cells that are genetically modified to produce functional beta-globin. Safety and effectiveness were shown in two studies. Of 41 patients who received the orphan drug, 89% achieved transfusion independence and did not need any red blood cell transfusions for at least 12 months. The most common adverse reactions are reduced platelet and other blood cell levels, mucositis, febrile neutropenia, vomiting, pyrexia, alopecia, epistaxis, abdominal pain, musculoskeletal pain, cough, headache, diarrhea, rash, constipation, nausea, decreased appetite, pigmentation disorder, and pruritus. As there is a risk of blood cancer associated with the treatment, patients who receive it should have their blood monitored for any evidence of cancer for at least 15 years.

Olipudase alfa (Xenpozyme) for IV infusion in adult and pediatric patients with acid sphingomyelinase deficiency, a rare genetic disease that causes premature death. The drug is the first approved medication to treat symptoms that are not related to the central nervous system in patients with acid sphingomyelinase deficiency. It is an enzyme replacement therapy that helps reduce sphingomyelin accumulation in the liver, spleen, and lung. Efficacy was shown in a randomized study of 31 patients, which found that treatment with the drug improved lung function and reduced liver and spleen size compared with placebo. The most common side effects include headache, cough, fever, joint pain, diarrhea, and low blood pressure. The drug carries a boxed warning for severe hypersensitivity reactions, including anaphylaxis. It should not be started during pregnancy due to the potential for fetal harm.

Marketing of the Vibrant System, an orally administered vibrating capsule intended for treating chronic idiopathic constipation. The device is indicated in those who have not experienced relief by using available laxative therapies for at least a month. The system is made up of a single-use capsule and a pod, which controls the activation of the capsule.

First-time generic approvals

Azilsartan medoxomil tablets (40 mg and 80 mg) to treat hypertension. (Brand name: Edarbi)

Fenoprofen calcium capsules USP (400 mg) for the relief of mild to moderate pain in adults, relief of the signs and symptoms of rheumatoid arthritis, and relief of the signs and symptoms of osteoarthritis. (Brand name: Nalfon)

Empagliflozin and metformin hydrochloride tablets (5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. (Brand name: Synjardy)

Sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution (10 mg/3.5 g/12 g per packet) for the cleansing of the colon as a preparation for colonoscopy in patients ages 9 years and older. (Brand name: Prepopik)

Minocycline for injection USP (100 mg per vial in single-dose vials) to treat infections caused by certain gram-negative and gram-positive bacteria, and others, when bacteriologic testing indicates appropriate susceptibility. (Brand name: Minocin)

Pirfenidone tablets (267 mg, 534 mg, and 801 mg) to treat idiopathic pulmonary fibrosis. (Brand name: Esbriet)

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