RSV vaccine approved; several actions on opioids

Recalls and warnings

A class I recall of the Ivenix Infusion System by Fresenius Kabi USA LLC due to a fluid leak that may delay or interrupt treatment. There have been 14 related complaints and no reported injuries or deaths. The recall includes 1,546 devices distributed from Oct. 27, 2021, to Jan. 30, 2023.

A class I recall of certain reworked DreamStation devices by Philips Respironics because they may deliver inaccurate or insufficient therapy. The recall is for certain reworked DreamStations that were also recalled in June 2021 and provide both continuous positive airway pressure and bilevel positive airway pressure support. Some devices were assigned incorrect or duplicate serial numbers during initial programming, which can prevent therapy delivery or cause therapy to be delivered using the wrong prescription or factory default settings. The company has received 43 complaints about this issue. No related injuries or deaths have been reported. The recall includes 1,088 devices distributed from Dec. 1, 2021, to Oct. 31, 2022.

A recall of 13 lots of fentanyl buccal tablets by Teva Pharmaceuticals USA due to a labeling error. The company manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne's label. Safety updates were omitted in the product insert/medication guide. No related complaints or adverse events have been reported.

A recall of one lot of atovaquone oral suspension USP (750 mg/5mL) by Camber Pharmaceuticals Inc. due to potential contamination with Bacillus cereus . No related adverse events have been reported. Recalled products were distributed nationwide to wholesalers, distributors, retail pharmacies, and mail-order pharmacies.

A recall of various drug products within expiry by Akorn Operating Company LLC due to company shutdown. The company filed Chapter 7 bankruptcy and has shut down all operations and terminated its employees of all U.S. sites.

A recall of all lots of nonsterile Alcohol Antiseptic 80% and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizers by Jarman's Midwest Cleaning Systems because FDA testing detected methanol. No related adverse events have been reported. Recalled products were distributed nationwide to wholesale distributors and local retailers.

Miscellaneous

Several updates to the prescribing information for both immediate-release (IR) and extended-release/long-acting (ER/LA) opioid pain medicines, including stating that the risk of overdose increases as the dose increases. The updates to IR opioids state that these products should not be used for an extended period unless the pain remains severe enough to require them and alternative treatment continues to be inadequate and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine. The FDA is also updating the approved use for ER/LA opioid pain medicines to recommend they be reserved for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate. There is also a new warning about opioid-induced hyperalgesia for both IR and ER/LA opioid pain medicines that describes the symptoms differentiating opioid-induced hyperalgesia from opioid tolerance and withdrawal. In addition, information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression and risks associated with using opioids in conjunction with benzodiazepines or other medicines that depress the central nervous system.

A new requirement for manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional disposal option for patients. The action followed a Federal Register notice issued in April 2022 that sought public comment on a potential modification of the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that mail-back envelopes be dispensed and education on safe disposal be provided with opioid analgesics dispensed in an outpatient setting. There are multiple existing mail-back envelope programs operating in the U.S., and commercially available mail-back envelopes are nondescript, are fit for purpose, and can safety and securely transport unused medicines from the patient's home to a location where they will be destroyed, the FDA said.

A safety communication for certain continuous glucose monitoring systems by Abbott due to the potential for battery swelling and overheating. The safety concerns apply to glucose readers used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems. The manufacturer initiated a voluntary medical device correction in February to emphasize the device instructions due to a limited number of user reports worldwide (0.0017%) that the reader's lithium-ion battery swelled, infrequently overheated, or, in very rare cases, sparked or caught fire. This issue does not affect any FreeStyle Libre sensors. The company is not physically recalling any readers, and customers may continue to use their readers, which remain safe when properly stored, charged, and used only with their accompanying USB cable and power adapter.

A safety communication about certain dental devices used on adults. The FDA is evaluating safety concerns with the use of fixed (nonremovable) palatal expanders used on adults to remodel the jaw or to treat such conditions as obstructive sleep apnea and temporomandibular joint disorder. The safety and effectiveness of these devices have not been established, and the devices are not cleared or approved by the FDA. The agency is aware of reports of serious complications with the use of these devices, including chronic pain, dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss. These complications typically require intervention by a health care professional.

A letter to clinicians and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service software in certain sequencing instruments by Illumina. The vulnerability affects the MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments. The company developed a software patch to protect against the exploitation of this vulnerability. There have been no reports indicating that it has been exploited.

Approvals

The first respiratory syncytial virus (RSV) vaccine approved for use in the U.S. (Arexvy). It is indicated to prevent lower respiratory tract disease caused by RSV in individuals ages 60 years and older. Safety and effectiveness were based on the FDA's analysis of data from an ongoing randomized controlled trial of a single dose versus placebo. Data were from the first season of the study, which will last three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination. The vaccine significantly reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6% and reduced the risk of developing severe RSV-associated disease by 94.1%. The most common side effects include injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Atrial fibrillation within 30 days of vaccination was reported in 10 participants who received the vaccine and in four who received placebo. In another study, two participants developed acute disseminated encephalomyelitis (ADEM) seven and 22 days after receiving the vaccine along with the influenza vaccine. One of these participants died. In yet another study, one participant developed Guillain-Barré syndrome nine days after receiving the vaccine. The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. The company has also committed to assessing atrial fibrillation in the postmarketing study, although not required by the agency.

The first over-the-counter naloxone nasal spray (Narcan). The 4-mg spray was first approved by the FDA in 2015 as a prescription drug that rapidly reverses the effects of opioid overdose. In accordance with a process to change the drug status from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling and showed that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional.

The MiniMed 780G System for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for the management of type 1 diabetes in patients ages 7 and older requiring insulin. It is also intended to continuously monitor glucose values in the fluid under the skin. The system includes SmartGuard Technology, which can be programmed to automatically adjust insulin delivery based on glucose values from continuous glucose monitoring sensors and can suspend delivery of insulin when the SmartGuard value falls below or is predicted to fall below predefined threshold values. The FDA also approved a modification to the system to enable the firmware over-the-air update feature, which allows patients to receive firmware updates directly to their pump.

The Selux AST System for use with the Selux Gram-Negative Comprehensive Panel. It was also cleared for use with the Selux Gram-Positive Comprehensive Panel. The system is an in vitro diagnostic test system used for antimicrobial susceptibility testing and allows for simultaneous testing of a larger number of drugs and drug concentrations than previous systems. The two panels also may expand to incorporate new drugs in the future, the FDA said.

Marketing of the Masimo SafetyNet Opioid System, a monitoring device intended to recognize and respond when an individual may be experiencing opioid-induced respiratory depression. The device monitors several physiological markers to detect the impairment of oxygenation due to opioid use and uses software that can notify personal contacts and/or trigger a wellness call to the device user by an emergency medical service dispatch to help ensure necessary treatment, such as naloxone. The system is intended for individuals ages 15 years and older and can be used in a hospital or in an in-home setting.

Marketing of the MISHA Knee System, an implant placed alongside the knee joint to help reduce the amount of load carried by part of the joint. Unlike conventional knee replacement, the knee joint is not removed with this device. The system is indicated for patients with osteoarthritis of certain parts of the knee who have failed to find relief with surgical or nonsurgical treatment, are still experiencing pain that interferes with activities of daily living, and are unwilling to undergo or are ineligible for total knee replacement due to age or absence of advanced osteoarthritis.

Marketing of the NTX100 Tonic Motor Activation System to reduce the symptoms of primary moderate to severe restless legs syndrome (RLS) and to improve sleep quality among drug-resistant RLS patients. The noninvasive system is available by prescription only and includes two separate therapy units and two separate electrode patches that are placed below the knees to provide high-frequency, low-level electrical stimulation to the peroneal nerves. The patient can start or stop the stimulation, adjust intensity, or read battery status via a simple user interface. The prescribing clinician can calibrate therapy output specific to each patient with a clinician app, which is used exclusively in the clinic and by the clinician.

Marketing of the RemeOs Screw LAG Solid, a first-of-its-kind absorbable metal alloy screw intended for use in surgical internal fixation of bone fractures and after osteotomies. It is indicated for fixation of the medial malleolus. The implants serve as temporary fixation and stabilization devices until fusion of bone fragments common to both fractures and osteotomies. They are intended for skeletally mature adults.

Marketing of the Bateman Bottle Breast Implant Removal System. The single-patient, single-use suction device is used to assist in the removal of one intracapsular ruptured silicone breast implant. The device is not intended for en bloc removal (when the scar tissue capsule and breast implant are removed together as one unit) and is not intended to remove residual silicone or be applied directly to tissue.

First-time generic approvals

Acetaminophen and ibuprofen tablets (250 mg/125 mg) to temporarily relieve minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, and minor pain of arthritis. (Brand name: Advil Dual Action with Acetaminophen)

Tiopronin delayed-release tablets (100 mg and 300 mg) to prevent cystine stone formation in patients ages 9 years and older with severe homozygous cystinuria, who are not responsive to nonpharmacological measures alone. (Brand name: Thiola)

Doxepin hydrochloride cream (5%) for the short-term (up to eight days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (Brand name: Zonalon)

Topiramate extended-release capsules (200 mg) as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients ages 6 years and older; as adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients ages 6 years and older; and for preventive treatment of migraine in patients ages 12 years and older. (Brand name: Trokendi XR)

Tirofiban hydrochloride injection (5 mg/100 mL [50 µg/mL in single-dose containers]) to reduce the rate of thrombotic cardiovascular events (combined end point of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome. (Brand name: Aggrastat)

Note: The FDA states that drugs are not always commercially available immediately after approval.