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 and do not require further action.
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.
A recall of one lot of vancomycin hydrochloride for injection USP (750 mg/vial) manufactured by Hospira due to the presence of glass in a single vial. No adverse events have been reported in association with the affected lot, which was distributed from August 2016 through January 2017.
A safety alert about pembrolizumab (Keytruda) in multiple myeloma. Based on data from two recently suspended clinical trials, the FDA warned about the risks of use in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) in this population. Interim results from the trials showed an increased risk of death for those receiving the combination treatment compared to those in the control group. The statement does not apply to patients taking pembrolizumab for an approved indication, such as melanoma, lung cancer, head and neck cancer, or classical Hodgkin lymphoma.
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 label accordingly.
A class I recall of 5,049 intra-aortic balloon pumps manufactured by Datascope Corp./MAQUET due to false blood detection alarms and the ingress of fluid into the device. Affected models include CS100i, CS100, or CS300 pumps distributed between March 24, 2003, and June 16, 2017.
A recall of three lots of alteplase (Activase) 100-mg vials, co-packaged with sterile water for injection, due to lack of sterility assurance. In affected lots distributed to hospitals, the water vials may be cracked or chipped at the neck and leaking.
A recall of two lots of VV28F reinforced dual-lumen ECMO catheters manufactured by OriGen due to the potential separation of the extension tube from the hub. At least two product failures have occurred.
A recall of one lot of hydromorphone hydrochloride injection USP CII and four lots of norepinephrine bitartrate injection USP (Levophed) manufactured by Hospira due to a lack of sterility assurance. A damaged sterilizing filter for nitrogen was used during the manufacturing process, which raised sterility concerns.
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 recall of all unexpired lots of oxytocin compounded with either lactated Ringer's or lactated Ringer's and dextrose manufactured by PharMEDium Services, LLC, due to reports of subpotency. Affected products were produced between July 6 and Aug. 29, 2017, and distributed to hospitals nationwide.
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 reminder that using thermoregulation devices during surgery has demonstrated less bleeding, faster recovery times, and decreased risk of infection for patients. While some clinicians may be avoiding the use of forced-air thermoregulating systems due to concerns of surgical-site infections, the FDA has not found a consistent association after reviewing the available evidence. The agency continues to recommend the use of thermoregulating devices, including forced-air thermal regulation systems, for surgical procedures when clinically warranted.
Combined meropenem and vaborbactam (Vabomere) to treat adults with complicated urinary tract infections (UTIs), including pyelonephritis, caused by specific bacteria. Meropenem is an antibacterial and 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.
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.
Senographe Pristina with Self-Compression, the first 2-D digital mammography system that allows patients to increase or decrease the amount of compression on their breast before the X-ray is taken. Patients can use the system's handheld wireless remote control to adjust the compression force before the technologist checks the applied compression and breast positioning, readjusting if necessary. Allowing self-compression did not negatively impact image quality or significantly increase the time of the exam in a clinical validation study.
Bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) to treat multiple types of cancer. The drug is the first biosimilar approved for the treatment of cancer in the U.S. Approved indications include certain colorectal, lung, brain, kidney, and cervical cancers. Common side effects include nosebleeds, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal bleeding, excessive tear production, back pain, and skin irritation. Serious side effects include perforation or fistula, arterial and venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, proteinuria, infusion-related reactions, and ovarian failure. It carries a boxed warning about increased risk for gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal bleeding.
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.
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.