Recalls and alerts
A class I recall of the JET 7 Reperfusion Catheter with Xtra Flex Technology by Penumbra due to the potential for device malfunctions and the risk of unexpected death or serious injury when used for removing clots in stroke patients. The FDA has received more than 200 medical device reports associated with the catheter, including 14 patient deaths, as well as serious injuries including vessel damage, hemorrhage, and cerebral infarction. Device malfunctions include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip. The recall includes 22,656 devices distributed from June 17, 2019, to Dec. 14, 2020. The recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
A class I recall of the Liko Multirall 200 Overhead Lift by Hillrom due to customer reports that the strap lock does not attach to the carriage hook as it should. There have been 34 complaints about this device issue and 22 reports of serious injuries. Two deaths have been reported. Recalled devices were distributed from Dec. 17, 2000, to Oct. 1, 2020.
A class I recall of the EMBLEM S-ICD (subcutaneous implantable cardioverter defibrillator) system by Boston Scientific due to risk of short-circuit. A manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high-voltage shocks. The company has received six complaints about this issue. There have been no reports of injuries or deaths. A total of 2,825 recalled devices were distributed from June 1, 2015, to Sept. 30, 2019.
A class I recall of the EMBLEM S-ICD Subcutaneous Electrode by Boston Scientific due to an increased risk of device fracture. There have been 27 complaints about this issue and 26 reports of serious injuries. One death has been reported. The recall includes 19,919 devices distributed from June 2017 to the present.
A class I recall of Medfusion 3500 and 4000 Syringe Pumps by Smiths Medical due to a software error that may lead to over-delivery or under-delivery of fluids or medication. There have been four complaints regarding this device issue, including one serious injury. No deaths have been reported. A total of 46,395 devices were distributed from Nov. 1, 2013, to the present.
A recall of unused Medtronic Valiant Navion thoracic stent graft system devices by Medtronic due to the potential for stent fractures. Data from a global clinical trial showed that three patients were observed to have stent fractures, two of whom had confirmed type IIIb endoleaks. One patient death was reported. In further analysis of images from participants, seven out of 87 patients had stent ring enlargement beyond the design specification. The company is currently conducting a root-cause investigation, including further review of follow-up clinical trial imaging, to determine potential clinical importance.
An alert that tofacitinib (Xeljanz, Xeljanz XR) may be associated with an increased risk of serious heart-related events and cancer compared to tumor necrosis factor (TNF) inhibitors, according to preliminary results from a safety clinical trial required by the FDA. The trial also investigated other potential risks, including blood clots in the lungs and death. In 2019, the FDA warned that interim trial results showed an increased risk of blood clots and death with the higher 10-mg twice-daily dosage of tofacitinib and, as a result, approved a boxed warning for the prescribing information. Initial results from the clinical trial showed a higher occurrence of serious heart-related events and cancer in patients with rheumatoid arthritis treated with both this higher dose and a lower dose of the drug compared to patients treated with a TNF inhibitor. The FDA is awaiting additional results from the trial. In the meantime, clinicians should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue the medication and should continue to follow the recommendations in the drug's prescribing information, the agency said.
A recall of two batches of enoxaparin sodium injection USP by Apotex Corp. due to mislabeling of the syringe barrel measurement markings. A packaging error resulted in some barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8 mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) and vice versa. Recalled products were distributed nationwide to wholesalers and warehousing chains.
A safety communication informing clinicians and patients about the limitations of pulse oximeters. While the devices are useful for estimating blood oxygen levels in patients with COVID-19 who monitor their condition at home, they have a risk of inaccuracy under certain circumstances that should be considered. For example, a recent report suggested that pulse oximeters may be less accurate in people with dark skin pigmentation, the FDA said.
An update from the FDA and the U.S. Department of Agriculture underscoring that there is no credible evidence of food or food packaging as a likely source of SARS-CoV-2 transmission. Based on currently available scientific information and international scientific consensus, the foods that consumers eat and the food packaging they touch are highly unlikely to spread the virus, the agencies said.
Policies to guide medical product developers addressing virus variants. The guidance focuses on vaccines and diagnostic and therapeutic products to address the emergence and potential future emergence of variants of SARS-CoV-2.
Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include piperacillin and tazobactam for injection and furosemide injection.
Trilaciclib (Cosela) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small-cell lung cancer. The drug, the first therapy in its class, inhibits cyclin-dependent kinase 4/6. Effectiveness was assessed in three randomized, double-blind, placebo-controlled studies in a total of 245 patients with extensive-stage small-cell lung cancer. In all three studies, those who received the drug had a lower chance of having severe neutropenia compared to those who received placebo. Of patients who had severe neutropenia, those who received the drug, on average, had severe neutropenia for a shorter time than those who received placebo. The most common side effects include fatigue; low levels of calcium, potassium, and phosphate; increased levels of aspartate aminotransferase; headache; and pneumonia. Patients should also be advised about injection-site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.
Marketing of a prescription-only device intended to reduce snoring and mild obstructive sleep apnea. The eXciteOSA device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue. The mouthpiece has four electrodes, two located above the tongue and two located below the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state for a period of six weeks and once a week thereafter. Unlike devices used when patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep. Safety and effectiveness were assessed in 115 patients with snoring who used the device for six weeks and then discontinued use for two weeks before they were reassessed. Overall, the percent of time spent snoring at levels louder than 40 dB decreased by more than 20% in 87 patients (76%). In a subgroup of 48 patients with snoring and mild obstructive sleep apnea, the average Apnea-Hypopnea Index decreased by 48%, from 10.21 to 5.27, in 41 out of 48 patients (85%). The most common adverse events were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw. The device is contraindicated in patients with pacemakers or implanted pacing leads; patients with temporary or permanent implants, dental braces, intraoral metal prosthesis, restorations, or appliances or dental jewelry in the mouth; patients who are pregnant or may be pregnant; and patients suffering from ulcerations in or around the mouth. Patients should receive a comprehensive dental examination prior to using the device.
Marketing of a noninvasive device intended to help protect athletes' brains during head impacts. The device, called Q-Collar, is a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space. It is indicated for athletes ages 13 years and older who have been medically cleared to play contact sports. Safety and effectiveness were assessed in several studies, including a longitudinal study in the U.S. with 284 participants on a high school football team. During the sports season, 139 athletes wore the Q-Collar and 145 athletes did not, and each wore an accelerometer to measure impacts to the head during play. All underwent an MRI scan preseason and postseason. One hundred six of 146 (73%) participants who didn't wear the collar had significant changes in deeper tissues of the brain involved in the transmission of electrical nerve signals. In contrast, 107 of 139 (77%) who wore the collar had no significant changes in these regions of the brain. No significant adverse events were associated with device use. The collar does not replace, and should be worn with, other protective sports equipment, the FDA said. It can be worn for up to four hours at a time and should be replaced after two years of active use or the product's expiration date, whichever comes first.
Casimersen injection (Amondys 45) for the treatment of Duchenne muscular dystrophy in patients with a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This is the first FDA-approved targeted treatment for patients with this type of mutation. The drug was evaluated in a double-blind study in which 43 male patients ages 7 to 20 years were randomized 2:1 to receive either IV casimersen (30 mg/kg) or placebo. Patients who received the drug had a significantly greater increase in dystrophin protein levels from baseline to week 48 of treatment compared with those who received placebo. The most common side effects were upper respiratory tract infections, cough, fever, headache, joint pain, and throat pain.
First generic drug approvals
Levothyroxine sodium capsules (88 µg, 100 µg, and 125 µg) for patients ages 6 years and older with hypothyroidism. (Brand name: Tirosint)
Argatroban injection (50 mg/50 mL [1 mg/mL in single-dose vials]) for the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia and as an anticoagulant in adult patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention. (Brand name: None provided)
Epoprostenol for injection (0.5 mg/vial and 1.5 mg/vial) for the treatment of pulmonary arterial hypertension (World Health Organization Group 1) to improve exercise capacity. (Brand name: Veletri)
Ferumoxytol injection (510 mg iron/17 mL [30 mg/mL] in single-dose vials) for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron, who have had unsatisfactory response to oral iron, or who have chronic kidney disease. (Brand name: Feraheme)
Imiquimod cream USP (3.75%) for the topical treatment of clinically typical, visible, or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults and for the topical treatment of external genital and perianal warts/condyloma acuminata in patients ages 12 years and older. (Brand name: Zyclara)
Note: The FDA states that drugs are not always commercially available immediately after approval.