Recalls and warnings
An urgent medical device correction about the HeartMate II Left Ventricular Assist System by Thoratec Corporation after reports from several hospitals about advisory alarms because of the expiration of the devices' backup batteries. In response to the alarms, some patients attempted to switch from the primary to backup system CO2 ntroller. Of these, 3 were unable to connect their pump to their backup system controller in a timely manner, resulting in 2 patient deaths and 1 serious injury. The company has reminded hospitals with patients supported by this system to monitor the expiration date of the backup battery in the system controller, which has a 36-month expiration date.
A warning that dipeptidyl peptidase-4 (DPP-4) inhibitors may cause joint pain that can be severe and disabling. The FDA has added new warning and precaution labels about this risk for all medicines in this drug class, including sitagliptin, saxagliptin, linagliptin, and alogliptin, and recommends that clinicians should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate.
A strengthened warning on canagliflozin (Invokana, Invokamet) about increased risk of bone fractures and decreased bone mineral density. Clinicians should consider factors that contribute to fracture risk prior to starting patients on canagliflozin, which has also been linked to decreases in bone mineral density at the hip and lower spine. The FDA continues to evaluate the risk of bone fractures with other sodium-glucose cotransporter-2 (SGLT2) inhibitors, such as dapagliflozin and empagliflozin, to determine if additional label changes or studies are needed.
A class I recall of the Alaris Medley Large Volume Pump frame membrane by Elite Biomedical Solutions. The company discovered that use of the frame membrane (the part of the pump that prevents fluids from leaking into internal components) can result in over- or under-infusion of fluids to the patient, posing a potential risk of patient injury or death.
A class I recall of the Alaris Syringe Pump by CareFusion. An alarm error that causes the pump to stop supplying the infusion may cause interruption of therapy. The manufacturer has received 108 reports of this issue, but there have been no reports of permanent injury or death.
A class I recall of Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube by Teleflex Medical. The tube's double-swivel connector may break or separate in the tube, which can cause the device to leak and therefore can cause hypoxia or respiratory distress in patients. This can lead to the need to reintubate the patient, patient injury, or death.
A recall of all nonexpired drug products produced for sterile use by Medistat RX because of possible contamination. Recalled products were distributed between Nov. 1, 2014, and Sept. 3, 2015. There have been reports of several adverse events that may be associated with these drug products, and after inspections raised concerns about the facility's ability to assure sterility, it voluntarily ceased sterile compounding operations on Sept. 1.
An expanded warning on compounded or repackaged drugs stored in Becton-Dickinson (BD) general use syringes. Syringes of 1 mL, 10 mL, 20 mL, and 30 mL as well as oral syringes were added to the warning on the 3-mL and 5-mL varieties based on reports that an interaction with the rubber stopper can cause some drugs stored therein to lose potency if filled and not used immediately. The manufacturer reports that the following drugs can be affected by the stoppers, although the FDA does not know whether other drugs may be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanil.
A warning that flexible bronchoscopes pose a risk of infection if not correctly reprocessed. The FDA identified 2 recurrent themes that contribute to persistent device contamination or device-associated infections: failure to meticulously follow manufacturer instructions for reprocessing and continued use of devices despite integrity, maintenance, and mechanical issues. The FDA recommends strict adherence to the manufacturer's reprocessing, preventive maintenance, and repair instructions.
A class I recall of the Freedom Driver Systems used with the SynCardia temporary total artificial heart. A specific part of the Freedom Driver drive mechanism may fail and cause the device to stop pumping. Patients do not receive any advance warning that the device may fail. If it does fail, a continuous alarm will sound. If the Freedom Driver stops pumping, the patient will lose consciousness almost immediately, which may mean that the warning signals will not be helpful.
A recall of certain lots of the OmniPod Insulin Management System by Insulet Corporation because of the possibility that some pods may have a failure rate higher than current manufacturing standards. The cannula in affected pods may either completely retract or fail to fully deploy, which may cause the patient not to receive the expected insulin dose, or the pod may trigger an audible alarm indicating it will no longer deliver insulin and must be replaced. The recall is of 40,846 boxes, distributed from December 2013 to March 2015.
A risk evaluation and mitigation strategy (REMS) launched for liraglutide (Victoza), about risk of acute pancreatitis and medullary thyroid carcinoma (MTC). Physicians should educate patients regarding the risk of MTC and symptoms of thyroid tumors. Patients found incidentally to have thyroid nodules or elevated serum calcitonin should be referred to an endocrinologist. Physicians should observe patients carefully for signs and symptoms of pancreatitis after initiating or increasing the dose of the drug and discontinue the drug if pancreatitis is suspected.
Revised prescribing information and creation of a REMS program regarding clozapine's risk of severe neutropenia. Under the new program, neutropenia will be monitored by the absolute neutrophil count (ANC) only, and the requirements for ANC are being modified so that patients will be able to continue treatment with a lower ANC. Patients with benign ethnic neutropenia may also now be eligible for treatment with the drug.
A warning and label change due to the risk for dosing errors with combined ceftazidime and avibactam (Avycaz) because of confusion about the drug strength displayed on the vial and carton labels. The FDA received 3 reports of related medication error cases, but no adverse events were reported. The drug was initially approved with the vial and carton labels displaying the individual strengths of the 2 active ingredients, but it is dosed based on the sum of those ingredients. To prevent medication errors, the FDA has revised the labels to indicate that each vial contains 2.5 g of the combined drug, equivalent to ceftazidime 2 g and avibactam 0.5 g.
A recall of all lots of sterile products compounded and packaged by US Compounding, Inc. because of FDA concern over lack of sterility assurance. The products were distributed nationwide to patients, clinicians, hospitals, and clinics between March 14 and Sept. 9, 2015, and should not be used.
A warning on cranial perforators with an automatic clutch mechanism, which may fail to disengage, causing serious patient harm. Over the past 10 years, the FDA received more than 300 medical device reports of these mechanisms failing to disengage, which resulted in more than 200 injuries. Patient injuries include perforation of the dura mater, hemorrhage, brain contusion, cerebral tissue damage, and neurological deficit. Outcomes from these injuries include seizures, aphasia, delayed and prolonged hospitalization, and the need for additional procedures. Evidence suggests that failure to disengage is not specific to any manufacturer or brand of devices, and clinicians can mitigate this risk through proper use, patient considerations, and appropriate device selection.
Evolocumab (Repatha) injection for patients with high cholesterol who are unable to get their LDL cholesterol under control with current treatment options. The second drug approved in a new class of drugs called PCSK9 inhibitors, it is approved for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol. In clinical trials, participants taking evolocumab had an average reduction in LDL cholesterol of about 60% compared to placebo. The most common side effects include nasopharyngitis, upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising where the injection is given.
Rolapitant (Varubi) to prevent delayed-phase chemotherapy-induced emesis. The tablet form is approved in adults in combination with other antiemetic drugs that prevent nausea and vomiting associated with initial and repeat courses of chemotherapy. In 3 trials, patients taking rolapitant in combination with granisetron and dexamethasone had a greater reduction in vomiting and use of rescue medication for nausea and vomiting compared to those receiving placebo, granisetron, and dexamethasone. It is contraindicated with the use of thioridazine, and the most common side effects include neutropenia, hiccups, decreased appetite, and dizziness.
Cariprazine (Vraylar) capsules to treat schizophrenia and bipolar disorder in adults. In 3 clinical trials, it reduced the symptoms of schizophrenia compared to placebo, and the most common side effects were extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements. In 3 other trials, the drug reduced symptoms of bipolar disorder in participants, and the most common side effects were extrapyramidal symptoms, the urge to move, indigestion, vomiting, drowsiness, and restlessness. Cariprazine and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a boxed warning about the increased risk of death associated with their use in older people with dementia-related psychosis. No drugs in this class are approved to treat such patients.
Pembrolizumab (Keytruda) for patients with metastatic non-small cell lung cancer whose disease has progressed after other treatments. Eligible patients have tumors that express the protein PD-L1, detected with a companion diagnostic test. In an efficacy trial of 61 patients, the drug shrank tumors in 41% of patients, and this effect lasted between 2.1 and 9.1 months. Safety was studied in 550 patients, and the most common side effects were fatigue, decreased appetite, dyspnea, and cough. Pembrolizumab also has the potential to cause severe immune-mediated side effects.