Recalls and alerts
A class I recall of the Arrow-Trerotola Percutaneous Thrombolytic Device by Arrow-International due to risk of tip damage during use. A total of 35 complaints reporting tip separation have been submitted. Of these, 14 reported injuries and nine complaints involved use of a stent to manage the separated tip. No deaths have been reported. The recall includes 24,895 devices distributed from Feb. 1, 2020, to Dec. 31, 2021.
A class I recall of the Bellavista 1000 and 1000e Series Ventilators with specific software versions and configurations by Vyaire Medical due to reports of ventilators failing to ventilate and generating a technical failure alarm. There have been 18 complaints, seven injuries, and no reports of death. The recall includes 2,605 devices distributed from Jan. 26, 2017, to Dec. 23, 2021.
A recall of FDA-regulated products purchased from January 2021 through February 2022 from 404 Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri, and Tennessee due to the presence of rodents and rodent activity at the company's distribution facility in Arkansas. Recalled products that could be contaminated include over-the-counter medications, medical devices, and dietary supplements. The company is not aware of any related consumer complaints or reports of illness.
An alert that the FDA is investigating a possible increased risk of death with the cancer medicine umbralisib (Ukoniq), which is approved to treat two types of lymphoma. A trial conducted in patients with chronic lymphocytic leukemia found a possible increased risk of death in patients receiving the drug in combination with a monoclonal antibody compared to those in the control arm. Those receiving the drug combination also experienced more serious adverse events than controls. Although the trial was conducted in patients with chronic lymphocytic leukemia, an unapproved use, the FDA believes the findings have implications for its approved uses for marginal zone lymphoma and follicular lymphoma.
A class I recall of RNAstill MTM specimen collection kits by BASE10 Genetics because they were distributed without proper premarket clearance from the FDA. No related injuries, adverse health consequences, or deaths have been reported. The recall includes 455,791 kits distributed from Sept. 16, 2020, to Dec. 1, 2021.
A class I recall of the STANDARD Q COVID-19 Ag Home Test by SD Biosensor Inc. because the tests have not been authorized, cleared, or approved by the FDA for distribution or use in the U.S. No related injuries, adverse health consequences, or deaths have been reported. The recall includes up to 397,700 kits distributed from Aug. 26, 2021, to Jan. 30, 2022.
A class I recall of COVID-19 Direct Antigen Rapid Tests by E25Bio because the tests have not been authorized, cleared, or approved by the FDA for distribution or use in the U.S. The tests may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit. No related injuries, adverse health consequences, or deaths have been reported. The recall includes 73,300 tests distributed from September 2020 to November 2021.
Safety communications warning people not to use the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) by ACON Laboratories or the Celltrion DiaTrust COVID-19 Ag Rapid Test by Celltrion USE Inc. because they have not been authorized, cleared, or approved by the FDA for distribution or use in the U.S.
A revised emergency use authorization for tixagevimab copackaged with cilgavimab (Evusheld) to change the dosing for the authorized use as pre-exposure prophylaxis of COVID-19 in certain patients. Current data demonstrated that the drug may be less active against certain omicron subvariants. The dosing regimen was revised because available data indicated that a higher dose may be more likely to prevent infection by the COVID-19 omicron subvariants BA. 1 and BA 1.1 than the originally authorized dose.
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 letter to clinicians emphasizing the importance of lifelong surveillance, including imaging, in patients who have had abdominal aortic aneurysm endovascular aortic repair. Regular clinical follow-up and imaging are critical to detect device and treatment failures, and physicians should ensure they adhere to follow-up recommendations outlined in the device instructions for use and the Society for Vascular Surgery guidelines, the FDA said.
Draft guidance aimed at fostering the development of nonaddictive alternatives to opioids for acute pain management. The FDA issued the draft guidance to provide recommendations to companies developing nonopioid analgesics for acute pain lasting up to 30 days, typically in response to some form of tissue injury, such as trauma or surgery. The guidance fulfills certain requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act and supports the HHS Overdose Prevention Strategy, the FDA noted.
A new indication for empagliflozin (Jardiance) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The drug was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. It is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction. For the new indication, safety and effectiveness were evaluated as an adjunct to standard-of-care therapy in a randomized, double-blind trial comparing about 3,000 participants who received the drug (10 mg once daily) to about 3,000 who received placebo. Of those who received the drug for an average of about two years, 14% died of cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received placebo. This benefit was mainly attributable to fewer patients being hospitalized for heart failure. Side effects were generally consistent with those for patients with diabetes, including urinary tract infections and female fungal infections. The drug must not be used in patients who have had a previous serious allergic reaction to it or those who are on dialysis.
Marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and STIs during vaginal intercourse. In a clinical trial of about 500 men ages 18 through 54 years, the total condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse. The overall percentage of adverse events, such as STIs and discomfort, was 1.92%.
First-time generic approvals
Sofosbuvir tablets (400 mg) for the treatment of adult patients with genotype 1, 2, 3, or 4 chronic hepatitis C virus infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. (Brand name: Sovaldi)
Cyclosporine ophthalmic emulsion (0.05% in single-use vials) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, commonly known as dry eye. (Brand name: Restasis)
Carbidopa, levodopa, and entacapone tablets (12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg) for the treatment of Parkinson's disease. (Brand name: Stalevo)
Pirfenidone tablets (267 mg and 801 mg) for the treatment of idiopathic pulmonary fibrosis. (Brand name: Esbriet)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules (12.5 mg, 25 mg, 37.5 mg, and 50 mg) for the treatment of attention deficit hyperactivity disorder in patients ages 13 years and older. (Brand name: Mydayis)
Brimonidine tartrate ophthalmic solution (0.15%) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (Brand name: Alphagan P)
Note: The FDA states that drugs are not always commercially available immediately after approval.