Recalls, warnings, and label changes
A recommendation that clinicians should not withhold the opioid addiction medications buprenorphine and methadone from patients taking benzodiazepines or other drugs that depress the central nervous system. Although the combined use of these medications increases the risk of serious side effects, the harms of untreated opioid addiction usually outweigh these risks. Buprenorphine and methadone drug labels will be updated with this information, as well as detailed recommendations for minimizing the combined use of these medications with benzodiazepines.
A safety alert that a corrective firmware update is available for implantable cardiac pacemakers manufactured by Abbott (formerly St. Jude Medical). The update process, which addresses the device's cybersecurity vulnerabilities, takes about three minutes and requires an in-person clinician visit. The manufacturer detailed the update process in a letter sent to physicians on Aug. 28, 2017. Devices manufactured after this date have already been updated.
A safety alert that patients should avoid taking sodium polystyrene sulfonate (Kayexalate and generics) at the same time as other oral medications. The potassium-lowering drug works by binding with potassium in the intestines so that it can be removed from the body. A study found that sodium polystyrene sulfonate also binds to many common oral medications, decreasing their absorption and effectiveness. To reduce the likelihood of this occurrence, patients should take oral medicines at least three hours before or after taking sodium polystyrene sulfonate. Doses should be separated by six hours for patients with gastroparesis or other conditions that result in delayed gastric emptying. The agency will update the drug's labels accordingly.
A warning not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd. due to a lack of sterility assurance and other quality issues. The products were distributed in the U.S. by Total Resources International and Simple Diagnostics Inc.
A warning that some clinicians are incorrectly dosing the primary biliary cholangitis drug obeticholic acid (Ocaliva). Patients with moderate to severe liver impairment should be started on 5 mg of the drug once weekly, rather than the 5 mg daily dosing used for other patients, due to increased risk for liver injury and death. The drug may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The FDA is working with the manufacturer to address these safety concerns.
A recall of certain lots of diabetes infusion sets because the vent membrane may be susceptible to being blocked by fluid, which can lead to overdelivery of insulin shortly after an infusion set change. The infusion sets are used with Medtronic insulin pumps.
Combined meropenem and vaborbactam (Vabomere) to treat adults with complicated urinary tract infections (UTIs), including pyelonephritis, caused by specific bacteria. Meropenem is an antibacterial, whereas vaborbactam inhibits some of the resistance mechanisms used by bacteria. In a trial of 545 adults with complicated UTIs, 98% of those who received the IV drug were cured or had improvement in their symptoms, compared to 94% of those treated with piperacillin/tazobactam. Seven days after treatment, about 77% of those on the new drug had resolved symptoms and a negative urine culture test, compared to 73% of those on piperacillin/tazobactam. The most common adverse reactions are headache, infusion site reactions, and diarrhea. Serious risks include allergic reactions and seizures, and the drug should not be used in patients with a history of anaphylaxis to beta-lactams.
The first duodenoscope with a single-use disposable distal cap. The Pentax ED34-i10T model duodenoscope's new feature will improve access for cleaning and reprocessing. The scope also features a simpler user interface, improved ergonomics, improved image quality, and a reduced length.
Gemtuzumab ozogamicin (Mylotarg) to treat adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen. The orphan drug is also approved to treat patients ages 2 years and older with the condition who have experienced a relapse or a refractory response to initial treatment. The drug was previously approved in 2000 but was voluntarily withdrawn from the market after trials demonstrated safety concerns without confirming clinical benefit. The new approval includes a lower recommended dose, new patient population, and different schedule. In a trial of 271 patients, those who received the drug in combination with chemotherapy had a median event-free survival of 17.3 months versus 9.5 months in those who received chemotherapy alone. Another trial of 237 patients found increased overall survival with the drug compared to best supportive care (median of 4.9 months vs. 3.6 months), and a single-arm study of 57 patients found that 26% achieved complete remission lasting a median of 11.6 months. Common side effects include fever, nausea, infection, vomiting, bleeding, thrombocytopenia, stomatitis, constipation, rash, headache, elevated liver function tests, and neutropenia. Serious side effects include low blood counts, infections, liver damage, hepatic veno-occlusive disease, infusion-related reactions, and hemorrhage. The drug has a boxed warning about the risk of severe or fatal hepatotoxicity.
Copanlisib (Aliqopa) to treat adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. The kinase inhibitor received accelerated approval based on a single-arm trial of 104 patients. Overall, 59% of patients treated with the orphan drug experienced a complete or partial shrinkage of their tumors for a median of 12.2 months. Common side effects include hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, nausea, lower respiratory tract infections, and thrombocytopenia. Serious side effects include infections, hyperglycemia, hypertension, noninfectious pneumonitis, neutropenia, and severe skin reactions.
Marketing of the first medical mobile application to help treat substance use disorders. The Reset app is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana, and stimulant use disorders. Reset delivers cognitive behavioral therapy and includes a clinician dashboard in addition to the patient-facing app. In a multisite, unblinded 12-week trial of 399 patients, 40.3% of those who used the app with standard treatment had adherence to abstinence versus 17.6% of those on standard treatment alone. No side effects were associated with the prescription-only adjunct treatment, which is not indicated for patients on opioid agonist therapy, those who only misuse alcohol, or those who primarily misuse opioids.
First-time generic approvals
Docetaxel injection USP (160 mg/8 mL, 20 mg/2 mL single-dose vials; 80 mg/8mL, 160 mg/16 mL multidose vials) to treat patients with breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, squamous cell carcinoma of the head, and neck cancer. (Brand name: Taxotere)
Ephedrine sulfate injection USP (50 mg/mL single-dose vial) to treat clinically important hypotension occurring in the setting of anesthesia. (Brand name: Akovaz)
Esomeprazole magnesium delayed-release capsules (20 mg, over-the-counter) to treat frequent heartburn that occurs two or more days per week. (Brand name: Nexium 24HR)
Lanthanum carbonate chewable tablets (500 mg, 750 mg, and 1,000 mg base) to reduce serum phosphate in patients with end-stage renal disease. (Brand name: Fosrenol)
Oseltamivir phosphate for oral suspension (6 mg/mL) to treat influenza A and B in patients two weeks of age and older with flu symptoms for no more than 48 hours, as well as for prevention of the flu in patients ages 1 year and older. (Brand name: Tamiflu)
Tacrolimus injection (5 mg/mL, 1 mL single-dose vial) for prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. (Brand name: Prograf)
Note: The FDA states that drugs are not always commercially available immediately after approval.