Recalls and warnings
A class I recall of Medfusion 3500 and 4000 Syringe Pumps by Smiths Medical due to risk of medication delivery error. There have been four related complaints, including one serious injury. The recall includes 46,395 devices distributed from Nov. 1, 2013, to June 22, 2020.
A requirement that an updated boxed warning be added to the prescribing information for all benzodiazepine medications. The new information will describe the risks of misuse, addiction, physical dependence, and withdrawal reactions observed consistently across all the medicines in the class. The changes will apply to the warnings and precautions, drug abuse and dependence, and patient counseling information sections of the prescribing information. The FDA is also requiring updates to the existing patient medication guides to help educate patients and caregivers about these risks.
A warning that taking higher-than-recommended doses of diphenhydramine (Benadryl) can lead to serious heart problems, seizures, coma, or death. The FDA is aware of reports of teenagers ending up in EDs or dying after participating in the “Benadryl Challenge” encouraged in videos posted on social media. The agency is investigating these reports and conducting a review to determine if additional cases have been reported and will update the public once the review is complete.
A recall of four lots of amiodarone hydrochloride injection USP (450 mg/9 mL in cartons of 10 single-dose 9-mL vials) and tranexamic acid injection USP (1,000 mg/10 mL in cartons of 10 single-dose 10-mL vials) by Mylan N.V. due to a carton label mix-up. Cartons labeled as tranexamic acid injection USP may contain vials of amiodarone hydrochloride injection USP, and vice versa; however, the individual vials in the cartons are accurately labeled. Affected batches were distributed to wholesalers and hospital/clinical pharmacies between April and July 2020.
A recall of one lot of metformin hydrochloride for extended-release oral suspension (Riomet ER; 500 mg per 5 mL) by Sun Pharmaceutical Industries Inc. due to containing excess amounts of N-nitrosodimethylamine, a probable human carcinogen. Seven hundred forty-seven affected cartons were distributed nationwide to wholesalers.
A recall of 483 lots of thyroid tablets USP (Nature-Thyroid and WP Thyroid) in all strengths by RLC Labs Inc. due to subpotency. Testing of samples from six lots found the samples to be subpotent. The product may have as low as 87% of the labeled amount of liothyronine or levothyroxine.
A recall of one lot of 15-mg and one lot of 120-mg levothyroxine and liothyronine tablets (NP Thyroid, Thyroid Tablets USP) by Acella Pharmaceuticals LLC due to subpotency. Testing found that the product may have as low as 87% of the labeled amount of levothyroxine. The company has received four potentially related reports of adverse events for these lots, which were distributed nationwide.
A warning that the FDA continues to find contaminated hand sanitizer products. Several products labeled as containing ethanol/ethyl alcohol have been recalled due to methanol or 1-propanol contamination. Methanol and 1-propanol are not acceptable ingredients for hand sanitizer products and can be life-threatening when ingested. In addition, the FDA warned consumers about some alcohol-based hand sanitizers that are being packaged in containers that appear as food or drinks (e.g., beer cans, water bottles, children's food pouches) and may put people at risk of serious injury or death if ingested.
Reclassification of previously announced recalls of hardware for the Alaris infusion pump system by Becton Dickinson/CareFusion 303. The FDA has designated three of the recalls as class I recalls, which means that the agency has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Updated recommendations on the potential risks of dental amalgam fillings in certain high-risk individuals. After more than 20 years of evidence review, the FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the amalgam over time. As a result, the agency is recommending certain high-risk groups avoid getting dental amalgam fillings whenever possible and appropriate. High-risk groups include pregnant women, women who are planning to become pregnant, nursing women and their infants, children (particularly those under age 6 years), people with neurological disease (e.g., multiple sclerosis, Alzheimer's disease, Parkinson's disease), people with impaired kidney function, and people with known allergy to mercury or other components of dental amalgam. Individuals in these groups should consider alternative, nonmercury materials (e.g., composite resins, glass ionomer cements) when possible and appropriate. The FDA does not recommend removing or replacing existing amalgam fillings in good condition unless deemed medically necessary by a health care professional.
A broadened scope of the existing emergency use authorization for remdesivir (Veklury). Initially authorized to treat severe COVID-19, the drug may now be used to treat all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
An emergency use authorization for investigational convalescent plasma to treat COVID-19 in hospitalized patients. Based on the available scientific evidence, the FDA concluded that the product may be effective in treating COVID-19 and that its known and potential benefits outweigh the known and potential risks.
An emergency use authorization for the first antibody point-of-care test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July and is now authorized for point-of-care testing utilizing fingerstick blood samples in such settings as doctors' offices, hospitals, and urgent care centers. The lateral flow assay is also authorized for use with venous whole blood, serum, and plasma. Because even high-performing antibody tests may produce false results in a population with low prevalence, the results from two serology tests may be needed to generate reliable results, the FDA said.
An alert that medical gowns sold by Laws of Motion PPE, including surgical gowns, should not be used as personal protective equipment (PPE) at this time due to potential quality issues that affect the level of fluid-barrier protection. A letter to clinicians includes information for reporting problems with these gowns.
An emergency use authorization for the BinaxNOW COVID-19 Ag Card antigen test. The rapid antigen test is authorized for use in point-of-care settings within the first seven days of symptom onset in suspected COVID-19 by using swabs from the nasal cavity. The test is the first COVID-19 diagnostic test that a clinician can perform without an analyzer (i.e., by reading results directly from the testing card).
Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include dexmedetomidine hydrochloride in 0.9% sodium chloride injection, propofol injectable emulsion USP (200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL for single-patient use only), cisatracurium besylate USP (20 mg/10mL), and albuterol sulfate inhalation aerosol (90 µg [base]/actuation).
A reissued emergency use authorization for the Abbott ID Now COVID-19 test. Revisions to the rapid molecular test's previous authorization include a revised intended use to indicate that testing is for specimens collected from individuals with suspected COVID-19 within the first seven days of symptom onset, clarify that testing is authorized for certain laboratories meeting certain requirements, and clarify that U.S. testing facilities are required to report all results to the appropriate public health authorities. The reissued authorization also revised the labeling, updated conditions of authorization, and revised the clinician and patient fact sheets.
Removal of the boxed warning about amputation risk from the prescribing information for canagliflozin (Invokana, Invokamet, Invokamet XR). The FDA added the warning to the sodium-glucose cotransporter-2 inhibitor's label in 2017, based on data from two clinical trials that showed an increased risk of leg and foot amputations. Subsequently, additional clinical trials published in 2018 and 2019 led the FDA to approve canagliflozin to reduce the risk of heart attack, stroke, death, end-stage kidney disease, worsening kidney function, and hospitalization for heart failure. The FDA decided to remove the boxed warning based on the newly identified benefits of canagliflozin on heart and kidney disease and recent trials' findings of a lower risk for amputation than previously described, particularly when patients are appropriately monitored.
A new indication for mepolizumab (Nucala) to treat patients ages 12 years and older with hypereosinophilic syndrome. The drug is indicated to treat patients who have had the disease for six months or longer without another identifiable non-blood-related cause. Approval was based on a randomized, placebo-controlled trial of 108 patients, in which fewer patients in the treatment group (28%) had hypereosinophilic syndrome flares than those in the placebo group (56%), for a 50% relative reduction. The most common side effects include upper respiratory tract infection and pain in extremities. The drug is also FDA-approved for patients ages 6 years and older with severe asthma with an eosinophilic phenotype and for adults with eosinophilic granulomatosis with polyangiitis.
A companion diagnostic to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in patients with a form of metastatic non-small-cell lung cancer. The Guardant360 CDx assay is the first approved diagnostic to combine next-generation sequencing and liquid biopsy in one test in order to guide treatment decisions. It is approved both to provide information on multiple solid tumor biomarkers and to help identify EGFR mutations in patients who will benefit from treatment with osimertinib (Tagrisso), an FDA-approved therapy for a form of metastatic non-small-cell lung cancer.
First-time generic approvals
Dextrose (5%) and sodium chloride injection (0.3%) USP in 250-mL, 500-mL, and 1,000-mL bags for the parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient. (Brand name: None provided)
Ciprofloxacin (0.3%) and dexamethasone (0.1%) otic suspension USP to treat infections caused by susceptible isolates of the designated microorganisms in acute otitis externa in pediatric, adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. (Brand name: Ciprodex)
Dimethyl fumarate delayed-release capsules (120 mg and 240 mg) to treat patients with relapsing forms of multiple sclerosis. (Brand name: Tecfidera)
Mifepristone tablets (300 mg) for the control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance who are not candidates for surgery or in whom surgery has failed. (Brand name: Korlym)
Pantoprazole sodium for delayed-release oral suspension (40 mg) for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease; for the maintenance of healing of erosive esophagitis; and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (Brand name: Protonix)
Note: The FDA states that drugs are not always commercially available immediately after approval.