Recalls and alerts
A recall of various lots of injectable products by SCA Pharmaceuticals due to potential microbial contamination. Recalled products include succinylcholine chloride, hydromorphone, fentanyl, morphine, oxytocin, phenylephrine, calcium gluconate, and rocuronium. They were distributed to hospitals nationwide between July 27 and Oct. 5, 2017.
A voluntary market withdrawal of two lots of Octagam 10% (immune globulin intravenous [human]) liquid preparation due to an increased number of reported hypersensitivity events. There have been no reports of serious injury, but the manufacturer and public health authorities at the FDA have determined that suspending further administration of the products from these lots is the most prudent course of action.
A recall of two lots of compounded glutamine, arginine, and carnitine by United Pharmacy due to two adverse events. Two patients developed tissue erosion at the injection site after administration of the product, which had a pH of 10.9, an FDA analysis found. No glutamine was detected in the product sample. Compounded drugs are not evaluated by the FDA for safety and effectiveness, and there is no FDA-approved injectable glutamine, arginine, and carnitine product.
A warning that consumers should not use kratom (Mitragyna speciosa), a plant that has no FDA-approved uses. People use kratom to treat pain, anxiety, and depression, and the agency is concerned that the product, which affects the opioid brain receptors, may expose users to the risks of addiction, abuse, and dependence. Patients also use kratom to treat opioid withdrawal symptoms, but there is no reliable evidence to support such use. As the FDA evaluates all available scientific information about kratom, it encourages more research to better understand the substance's safety profile, including its use in combination with other drugs.
Aripiprazole tablets with sensor (Abilify MyCite), the first drug in the U.S. with a digital ingestion tracking system. The product, which records ingestion of the medication, is approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and adjunctive treatment of depression in adults. The pill's sensor sends a signal to a wearable patch, which then sends the information to a mobile application. Clinicians can access the data through a web-based portal with patients' permission. The product's label states that its ability to improve patients' adherence to their treatment regimens has not been shown and that it should not be used to track ingestion in real time or during an emergency. In clinical trials of the medication, the most common side effects were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. Skin irritation at the patch site may also occur. Prior to first use, clinicians should facilitate use of the drug, patch, and app to ensure patients are able and willing to use the system.
Marketing clearance and a waiver for a complete blood cell count test to be run in additional health care settings (e.g., physician's offices, clinics) and by a wide range of personnel (e.g., support staff). The expanded access to the test, called the XW-100 Automated Hematology Analyzer, will allow faster availability of results, according to the FDA. The test quantifies 12 hematology parameters and is indicated for patients ages 2 and older who require a whole blood cell count and white blood cell differential. The device was originally cleared in 2015 for use at the patient's point of care.
First-time generic approvals
Dextromethorphan hydrobromide and quinidine sulfate capsules (10 mg/20 mg) to treat pseudobulbar affect. (Brand name: Nuedexta)
Dapsone gel (5%) to topically treat acne vulgaris. (Brand name: Aczone)
Potassium chloride for oral solution USP (20 mEq) to treat potassium deficiency. (Brand name: Klor-Con Powder)
Carvedilol phosphate extended-release capsules (10 mg, 20 mg, 40 mg, and 80 mg) to treat hypertension. (Brand name: Coreg CR)
Methadone hydrochloride injection USP (200 mg/20 mL [10 mg/mL] multidose vial) to manage pain severe enough to require an opioid and for which alternative treatment options are inadequate, as well as to temporarily treat patients with opioid dependence who are unable to take oral medication.
Sodium acetate injection USP (400 mEq/100 mL [4 mEq/mL]) as a source of sodium to be added to large-volume IV fluids to prevent or correct hyponatremia in patients with restricted or no oral intake, and also as an additive for preparing specific IV fluid formulas when a patient's needs cannot be met by standard electrolyte or nutrient solutions.
Note: The FDA states that drugs are not always commercially available immediately after approval.