New antiviral for flu approved

Details on the latest alerts, recalls, and approvals.


Recalls and alerts

An alert about dosing errors and confusion with certain compounded injectable products, which are not evaluated by the FDA for safety, effectiveness, and quality. Multiple complaints have raised concerns that labels displaying the strength per milliliter in larger font than the strength per total volume can lead to confusion about how much of the drug is in the container. Two reports were associated with overdoses of fentanyl and ketamine. Other reports have referred to phenylephrine, neostigmine, and succinylcholine syringes, as well as an IV bag containing norepinephrine bitartrate.

Image by Getty Images
Image by Getty Images

A recall of two lots of methocarbamol 750-mg tablets USP (Robaxin) in 100-count bottle packs by Endo Pharmaceuticals Inc. due to a labeling error. The labels incorrectly state the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.”

A recall of one lot of prednisolone/gatifloxacin ophthalmic solution (1%/0.5% sterile 3-mL vials) by Promise Pharmacy due to unidentified small particulate floating in the solution. The product is used after cataract surgery and was distributed nationwide to individual patients.

Safety communications

Recommendations on the proper use of both standard and safety pen needles to inject medicines. The recommendations for patients, caregivers, and clinicians follow reports of patients using standard pen needles to inject insulin without removing the inner needle cover, which stopped the needle from entering the skin and delivering the insulin. Due to this issue, some patients developed hyperglycemia, and one hospitalized patient died. Patients can use the same pen injector with both standard and safety pen needles, but they may not know the differences between the two types of pen needles. Patients should be sure to remove both the outer and inner covers of standard pen needles (safety pen needles have only one removable outer cover), as well as check each new box of pen needles they receive to make sure they know how to use them.

A cybersecurity update for Medtronic cardiac implantable electrophysiology devices. The corrective software update addresses a safety risk caused by cybersecurity vulnerabilities that could allow an unauthorized user to change the functionality of the device and its programmer. The update will intentionally block the currently existing device programmer from using an internet connection to update software. Normal programming of the devices remains unchanged, as it does not require network connectivity, and reprogramming is not required as a result of the correction.

Approvals

Baloxavir marboxil (Xofluza) to treat acute uncomplicated influenza in patients ages 12 years and older who have had symptoms for no more than 48 hours. The antiviral drug, taken as a single oral dose, is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Safety and efficacy were tested in two randomized trials of 1,832 patients who received the drug, a placebo, or another antiviral flu treatment within 48 hours of symptom onset. In both trials, those who received the drug had a shorter time to alleviation of symptoms compared to those who received placebo, and the second trial found similar recovery time with the new drug and the other antiviral. The most common adverse reactions to the drug were diarrhea and bronchitis.

Amikacin liposome inhalation suspension (Arikayce) to treat lung disease caused byMycobacterium aviumcomplex bacteria in patients with refractory disease. Approved through an accelerated pathway, the drug was tested in a randomized trial in which one group of patients received it with a background multidrug antibacterial regimen and the other group received the multidrug antibacterial regimen alone. After six months of treatment, 29% of patients who received the drug had no growth of mycobacteria in their sputum cultures for three consecutive months, compared to 9% of controls. Common side effects include dysphonia, cough, ototoxicity, upper airway irritation, musculoskeletal pain, fatigue, diarrhea, and nausea. A boxed warning cautions about the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, which has led to hospitalizations in some cases.

First-time generic approvals

Cefixime capsules (400 mg) to treat adults and children ages 6 months and older with urinary tract infections, pharyngitis, tonsillitis, acute exacerbations of chronic bronchitis, and uncomplicated cervical or urethral gonorrhea. (Brand name: Suprax)

Albendazole tablets USP (200 mg) to treat parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. (Brand name: Albenza)

Estradiol transdermal system USP (0.025 mg/d, 0.0375 mg/d, 0.05 mg/d, 0.075 mg/d, and 0.1 mg/d) to treat moderate to severe vasomotor symptoms due to menopause and to prevent postmenopausal osteoporosis. (Brand name: Minivelle)

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