Recalls and alerts
An alert that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited. The FDA recommended following the manufacturer's instructions for cleaning, sanitizing, and reusing tracheostomy tubes for the maximum number of times allowed. Clinicians should consider using these conservation strategies in health care settings and encouraging their use in home settings, the agency said.
A class I recall of the Iso-Gard Filter S by Teleflex after reports that the filters may split or detach from breathing systems, potentially causing leakage and insufficient air supply to patients. There have been four reported injuries, including oxygen desaturation, related to this issue. The recall includes 60,500 devices distributed from Sept. 1, 2020, to July 5, 2022.
A class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager by Insulet Corporation due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard. There have been 455 related complaints, including reports of three fires. No injuries or deaths have been reported. The recall includes 248,288 devices distributed from July 27, 2018, to Aug. 31, 2022. The company also issued a separate medical device correction for the Omnipod 5 Automated Insulin Delivery System due to an issue with the controller's charging port and cable. There have been 24 reports of the charging port or cable melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port. No related serious injuries have been reported.
A class I recall of the WatchCare Incontinence Management System by Baxter International Inc. due to potential for radio frequency interference with other medical devices. The system includes specific Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads. There have been 96 complaints of interference, all but two at distances less than 1 meter. No related serious injuries or deaths have been reported. The recall includes 8,550 devices distributed from Aug. 1, 2018, to Sept. 1, 2022.
A recall of 49 lots of sodium bicarbonate injection USP (8.4%; 50-mEq/50-mL vial) by Exela Pharma Sciences LLC due to a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There have been five reports of flying glass injuring the skin, eyes, and/or other body parts. There have been no reports of sterility failures. Recalled products were distributed nationwide to wholesalers, distributors, and other customers between Dec. 16, 2021, and Aug. 10, 2022.
A recall of two lots of quinapril and hydrochlorothiazide tablets USP (20 mg/12.5 mg) by Aurobindo Pharma USA Inc. due to the presence of a nitrosamine impurity. Recalled products were found to contain n-nitroso-quinapril above the proposed interim limit. Shipping of the recalled batches began in May 2021.
A recall of one lot of octreotide acetate injection (500 µg/mL) by Mylan Institutional LLC due to a product complaint of the presence of glass particles in a syringe. The recalled lot was manufactured in Italy and was distributed in the U.S. from Jan. 11 to June 21, 2022.
An alert that the FDA is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease on dialysis treated with denosumab (Prolia). The agency's review of interim results from an ongoing safety study of the osteoporosis medicine suggested an increased risk of hypocalcemia in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with the drug showed a substantial risk with serious outcomes, including hospitalization and death. The agency will communicate final conclusions and recommendations when the review is completed.
An alert that certain Luer-activated valve (LAV) connectors with internal pin designs may not be compatible with prefilled glass syringes (e.g., naloxone prefilled glass syringes). The internal pin of the LAV connector may break when attached to a prefilled glass syringe, causing the LAV connector to clog and prevent administration of the drug. The FDA recommended that health care professionals be aware of these potential compatibility issues.
An emergency use authorization (EUA) for the cobas MPXV test for the qualitative detection of mpox virus DNA from human lesion swab specimens from individuals with suspected mpox infection. The test is for use on cobas 6800 and 8800 systems. Testing is limited to certified laboratories that meet the requirements to perform moderate- or high-complexity tests.
An update on medical device reports associated with the breakdown or suspected breakdown of the polyester-based polyurethane foam used in Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Since April 2021, the FDA has received more than 90,000 medical device reports, including 260 reports of death, that may be associated with this issue. The FDA will continue to publish updates about the status of the recall.
An update on the HeartWare Ventricular Assist Device System by Medtronic. In June 2021, the company stopped the sale and distribution of the system, given the increased risk of death and neurological adverse effects in patients using the device, as well as a malfunction where the device may fail to restart. The company announced that a backup controller with modified software is now available to all requesting hospitals and may help restart pumps if the primary controller fails.
A Federal Register notice with a preliminary assessment that certain naloxone products have the potential to be safe and effective for over-the-counter use. Naloxone drug products up to 4 mg for nasal spray and up to 2 mg for autoinjectors for intramuscular or subcutaneous use may be approvable as safe and effective for nonprescription use, according to the FDA; however, the agency needs more data to make its final determination.
An EUA for anakinra (Kineret) injection for the treatment of COVID-19 in certain hospitalized adults with pneumonia requiring supplemental oxygen. The drug is indicated in those who are at risk of progressing to severe respiratory failure and are likely to have an elevated level of plasma soluble urokinase plasminogen activator receptor. The drug is currently FDA approved for the treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes, and deficiency of IL-1 receptor antagonist.
Updated information for tixagevimab co-packaged with cilgavimab (Evusheld), which is currently the only option for pre-exposure prophylaxis of COVID-19. The FDA informed clinicians and patients about an increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by the drug. Clinicians should inform patients of this risk and advise those who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and to promptly seek medical attention, including starting treatment for COVID-19 as appropriate, if they test positive. The drug has an EUA for immunocompromised individuals who may not mount an adequate response to COVID-19 vaccination and individuals for whom COVID-19 vaccination is not recommended due to a history of a severe adverse reaction.
An EUA for the Lucira COVID-19 and Flu Test for use in a point-of-care setting. The single-use molecular test is intended for detection of both the SARS-CoV-2 virus and influenza (A or B) if respiratory viral infection consistent with COVID-19 is suspected. The test is indicated in patients ages 2 years or older and is collected by nasal swab by a clinician in a point-of-care setting.
Revised EUAs for all COVID-19 antigen tests. The FDA required updates to product labeling regarding repeat or serial testing in response to data showing that repeat testing after a negative result on a COVID-19 antigen test increases the chance of an accurate result irrespective of the presence of symptoms. The revised authorized uses include repeat testing, with at least 48 hours between tests, at least two times over three days for people with COVID-19 symptoms and at least three times over five days for those without symptoms.
Teplizumab-mzwv (Tzield) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients ages 8 years and older who currently have stage 2 type 1 diabetes. The first-in-class therapy is administered by IV infusion once daily for 14 consecutive days. In a trial of 76 patients with stage 2 type 1 diabetes, more patients who received placebo were later diagnosed with stage 3 type 1 diabetes compared to those who received the drug. The most common side effects include decreased levels of certain white blood cells, rash, and headache. The drug also carries warnings and precautions, including premedicating and monitoring for symptoms of cytokine release syndrome, risk of serious infections, decreased lymphocyte levels, risk of hypersensitivity reactions, and the need to administer all age-appropriate vaccinations before initiation, as well as avoiding concurrent use of live, inactivated, and mRNA vaccines.
Etranacogene dezaparvovec (Hemgenix), the first gene therapy to treat adults with hemophilia B. The orphan drug is indicated in those with congenital factor IX deficiency who currently use factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. The one-time gene therapy product is given as a single dose by IV infusion and consists of a viral vector carrying a gene for clotting factor IX. The gene is expressed in the liver to produce factor IX protein to increase blood levels of factor IX, thereby limiting bleeding episodes. The most common adverse reactions include liver enzyme elevations, headache, mild infusion-related reactions, and flu-like symptoms. Clinicians should monitor patients for adverse infusion reactions and liver enzyme elevations in the blood.
An expanded indication of the Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Boostrix) for immunization during the third trimester of pregnancy to prevent pertussis in newborns. While the vaccine's approval has always included its use in pregnancy to protect the vaccinated individual, the expanded indication is specific to use in pregnancy to prevent pertussis in infants younger than two months of age. The FDA's reanalysis of real-world data resulted in a preliminary estimate that the vaccine is 78% effective in preventing pertussis among infants younger than two months of age when administered during the third trimester of pregnancy. A randomized, placebo-controlled study with a non-U.S. formulation of the vaccine did not identify any vaccine-related adverse effects on pregnancy or on the fetus/newborn. In previous studies, the most commonly reported side effects were pain, redness at the injection site, headache, fatigue, and GI symptoms.
First-time generic approvals
Roflumilast tablets (250 µg and 500 µg) to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. (Brand name: Daliresp)
Darunavir tablets (600 mg and 800 mg) to treat HIV-1 infection in patients ages 3 years and older. (Brand name: Prezista)
Tazarotene gel (0.05% and 0.1%) for the topical treatment of plaque psoriasis of up to 20% body surface area involvement and for the topical treatment of mild to moderate facial acne vulgaris. (Brand name: Tazorac)
Mirabegron extended-release tablets (25 mg and 50 mg) to treat overactive bladder in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. (Brand name: Myrbetriq)
Riociguat tablets (0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg) to treat adults with persistent/recurrent chronic thromboembolic pulmonary hypertension that has already been treated with surgery or is inoperable to improve exercise capacity and World Health Organization (WHO) functional class, as well as for the treatment of pulmonary arterial hypertension to improve exercise capacity, improve WHO functional class, and delay clinical worsening. (Brand name: Adempas)
Cariprazine capsules (1.5 mg, 3 mg, 4.5 mg, and 6 mg) to treat schizophrenia in adults, for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and to treat bipolar depression in adults. (Brand name: Vraylar)
Gefitinib tablets (250 mg) for the first-line treatment of patients with metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations. (Brand name: Iressa)
Note: The FDA states that drugs are not always commercially available immediately after approval.