Recalls, warnings and label changes
A warning about combining amiodarone, sofosbuvir (Harvoni or Sovaldi), and another direct-acting antiviral for hepatitis C because symptomatic bradycardia has resulted, including a patient death. The sofosbuvir label is being updated and the FDA recommends that clinicians not prescribe these drugs in combination.
A strengthened warning on ferumoxytol (Feraheme) about the risk of serious, potentially fatal allergic reactions. A new contraindication also recommends against use of the drug in patients who have had an allergic reaction to any IV iron replacement product.
A recall of 1 lot of lactated Ringer's irrigation, 3000 mL, by Hospira, due to a customer report of several dark, fibrous particulates floating within the solution, which was found to be a common non-toxic, non-invasive mold, Aspergillus kanagawaensis.
A recall of select lots of IV solutions, including lactated Ringer's, sodium chloride, and dextrose, by Baxter due to particulate matter detected and identified during routine maintenance as material from a solution transmission system pump.
A Risk Evaluation and Mitigation Strategy for insulin inhalation powder (Afrezza) to inform clinicians about the risk of acute bronchospasm in patients with chronic lung disease. The drug is contraindicated in such patients and all patients should be evaluated for lung disease, with history, physical, and spirometry, before starting the drug.
A safety communication about mammograms performed at Richard D. Adelman, M.D., Family Medicine in Raleigh, NC, after Aug. 24, 2012. Quality problems have been identified and patients should have their mammograms reviewed at a certified facility to determine if they need a repeat mammogram or additional medical follow-up.
The Gastric Emptying Breath Test (GEBT), a non-invasive test to aid in the diagnosis of gastroparesis. The GEBT, conducted over a 4-hour period after an overnight fast, measures carbon dioxide in breath. Patients eat a test meal of a scrambled egg-mix and Spirulina platensis, a type of protein enriched with carbon-13. The test can determine how fast the stomach empties the meal by measuring the ratio of carbon-13 to carbon-12 collected in breath samples at multiple time points after the meal is consumed compared to baseline. Efficacy is based on a study of 115 patients finding that GEBT results agreed with gastric scintigraphy 73% to 97% of the time. Some patients reported nausea and stomach discomfort. The test should not be given to patients with hypersensitivity to Spirulina; egg, milk, or wheat allergens; certain lung diseases; or conditions that cause small bowel malabsorption.
An expanded indication for aflibercept (Eylea) to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME). It is administered as an injection into the eye once a month for the first 5 injections and then once every 2 months. Safety and efficacy of the new indication were based on 2 trials with 679 participants showing significant improvement in severity of DR. The most common side effects are bleeding of the conjunctiva, eye pain, cataracts, floaters, increased intraocular pressure, and vitreous detachment. Serious adverse reactions include endophthalmitis and retinal detachments. The drug was previously approved to treat wet age-related macular degeneration and DME and macular edema secondary to retinal vein occlusions.
Anthrax immune globulin intravenous (Anthrasil) to treat inhalational anthrax in combination with appropriate antibacterial drugs. Efficacy in monkey studies showed that the drug increased survival from 0 to 36 to 70%, and safety was tested in 74 healthy humans. The most common side effects were headache, back pain, nausea, and infusion site pain and swelling.
An expanded indication for the CoreValve System for aortic valve-in-valve replacement, for patients who have previously had a tissue aortic valve replacement or are at high or extreme risk for complications associated with traditional open-heart surgery. Safety and efficacy are based on a trial of 143 patients receiving the valve, who had a rate of survival without major stroke of 95.8% at 30 days and 89.3% at 6 months. Bleeding and major complications with the arteries were the most common early adverse events. The system was previously approved to treat patients with aortic stenosis who are considered to be at extreme or high risk for surgical aortic valve replacement.
The Impella 2.5 System, a miniature blood pump system for temporary use by patients with severe symptomatic coronary artery disease and diminished (but stable) heart function who are undergoing high-risk percutaneous coronary intervention (HRPCI) but are not candidates for surgical coronary bypass treatment. Approval was based on evidence that using the system during HRPCI could allow a longer and more thorough procedure by preventing episodes of hemodynamic instability and reduce later adverse events compared to an intra-aortic balloon pump.
Dinutuximab (Unituxin) to treat pediatric patients with high-risk neuroblastoma. It was approved under the orphan product program and carries a boxed warning about the risk of irritated and severely painful nerve cells, nerve damage, and life-threatening infusion reactions.
Cholic acid (Cholbam) capsules to treat bile acid synthesis disorders due to single enzyme defects and peroxisomal disorders (including Zellweger spectrum disorders). Efficacy for both indications was assessed in small trials lasting 18 years, which showed improvements in liver function tests and weight. The most common side effect was diarrhea. Use of the drug should be carefully monitored by an experienced hepatologist or pediatric gastroenterologist.
No changes in prescribing are recommended based on an FDA analysis of elevated levels of olanzapine pamoate (Zyprexa Relprevv) in 2 patients who died. Based on an animal study requested of the manufacturer, the agency was unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection, with the drug level increase observed possibly occurring after death. The drug already carries a boxed warning about post-injection delirium sedation.
New reprocessing instructions have been issued for the TJF-Q180V duodenoscope by Olympus. The FDA has reviewed these instructions and the validation data as part of its ongoing review and recommends that any facilities using this duodenoscope train staff on the new instructions and implement them as soon as possible. Key changes have been made to the precleaning, manual cleaning, and manual high-level disinfection reprocessing procedures.