Ventilators, pacemakers recalled; rehab device approved

Recalls

A class I recall of V60 and V60 Plus ventilators equipped with high-flow therapy (software versions 3.00 and 3.10) by Philips Respironics due to the risk of patients receiving reduced oxygen if the system pressure reaches the default maximum limit. This can occur if the oxygen flow is partially blocked. If the issue causing maximum system pressure is not resolved, the ventilator will continue to provide a lower oxygen flow rate and issue a low-priority alarm. There have been 61 incidents, 25 injuries, and no deaths reported. The recall includes 16,535 devices distributed from May 1, 2009, to June 2, 2021.

A class I recall of the INGENIO family of pacemakers and cardiac resynchronization therapy pacemakers by Boston Scientific due to a risk of transition to safety mode. Safety mode is intended to provide backup if the device is faulty. While in safety mode, the device cannot be reprogrammed and must be replaced. The company does not recommend preventive replacement for all recalled devices; however, it noted that shared decision making may support consideration of early device replacement to prevent unintended outcomes, particularly in patients with underlying health issues, pacemaker dependence, or problems with pacing. There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing. No deaths have been reported. The recall includes 48,000 devices distributed from Nov. 1, 2011, to Aug. 1, 2020.

A class I recall of Recirculator 8.0 Disposable Lavage Kits by Eight Medical International due to potential exposure to high levels of aluminum. The kits are used with the company's Hyperthermic Perfusion System and allow the system to circulate warm, sterile solution inside a patient's thoracic or peritoneal cavity to reach a target temperature during surgery. The heating element within the kit may release aluminum into this fluid during warming therapy. There have been no related complaints, injuries, or deaths reported. The recall includes 288 kits distributed from June 7, 2019, to June 7, 2021.

A class I recall of Dose IQ Safety Software (used with Spectrum IQ infusion pumps) by Baxter Healthcare due to a software defect that may improperly configure drug and fluid delivery. There have been 15 complaints, no injuries, and no deaths reported for this issue. The recall includes 61 devices distributed from Feb. 1, 2018, to Jan. 1, 2019.

A class I recall of the Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by Bio-Medical Equipment Service Co., due to possible cracked or separated bezel repair posts. The recall includes 718 devices distributed from July 10, 2020, to Feb. 18, 2021. No related complaints, injuries, or deaths have been reported.

A recall of four additional lots of varenicline (Chantix) by Pfizer due to the presence of N-nitroso-varenicline above the manufacturer's established acceptable daily intake level. There have been no reports of related adverse events. Recalled products were distributed nationwide to wholesalers and distributors from June 2019 to June 2021.

A recall of three lots of sodium bicarbonate in 5% dextrose injection (150 mEq per 1,000 mL) to the hospital pharmacy level by SterRx LLC due to microbial contamination. No related adverse events have been reported. Affected products were distributed to hospitals nationwide from May to June 2021.

A recall of one lot of lidocaine hydrochloride topical solution (4%) by Teligent Pharma Inc. due to superpotency. Testing by the company found this lot to be superpotent based on an out-of-specification result obtained at the 18-month stability timepoint. There have been no reports of related adverse events. Affected products were distributed at the wholesale and retail levels in the U.S. and Canada.

A recall of two lots of atovaquone oral suspension USP (750 mg/5 mL) to the consumer level by KVK Tech Inc. due to complaints of unusual grittiness in the product. The company determined the issue was most likely caused by prolonged exposure to extremely cold weather during shipment. No related adverse events have been reported. The two lots were shipped to a single distributor, which was notified as part of the recall.

A recall of certain 12-mL Monoject Flush Prefilled Saline Syringes (0.9% sodium chloride) by Cardinal Health due to their potential to reintroduce air into the syringe after the air has been expelled. The company has received 37 reports of the plunger pulling back. No injuries have been reported. The recall includes about 267 million syringes distributed between July 2019 and July 2021.

Miscellaneous

A letter informing clinicians to immediately stop use of and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical Inc. due to a risk of bacterial contamination with Burkholderia cepacia complex. The manufacturer has recalled certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. The product is also distributed as MediChoice Ultrasound Gel by both Owens & Minor and Mac Medical Supply Co. Inc.

Remediation of recalled Alaris System infusion pumps by BD. Under FDA guidance, the company released Alaris System software version 12.1.2 and associated ancillary software to remediate the issues identified in the previous recall and to provide programming, operational, and cybersecurity updates to affected devices. Customers can schedule remediation at no cost.

An urgent medical device correction for all Spectrum IQ infusion pumps by Baxter International to reinforce important safety information when customers implement changes to their network configuration and server systems. The company is developing a software upgrade that will assist how the pump responds to unstable network and server systems by reducing the stress on the pump's memory and processing functions if this occurs. The updated software was expected to be available early in the fourth quarter of 2021, and the company will work with customers to schedule the upgrades. To date, there have been no reports of related adverse events or injuries.

A reminder that the safety and effectiveness of robotically assisted surgical devices have not been established for use in mastectomy procedures or in the prevention or treatment of breast cancer. The FDA is aware of allegations that clinical studies are being conducted using these devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such studies. Clinicians should be aware that robotically assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy or for the prevention or treatment of breast cancer, the agency said.

COVID-19 updates

Approval of the first COVID-19 vaccine. The vaccine, which has been known as the Pfizer-BioNTech COVID-19 vaccine, is now marketed as Comirnaty for the prevention of COVID-19 disease in individuals ages 16 years and older. The FDA based its approval decision on updated data from a randomized controlled trial of thousands of participants showing that the vaccine was 91% effective in preventing COVID-19 disease. More than half of participants were followed for safety outcomes for at least four months after the second dose, and about 12,000 were followed for six months or more. The FDA reviewed postauthorization safety surveillance data pertaining to myocarditis and pericarditis and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among men under age 40 years compared to women and older men and highest in males ages 12 through 17 years, the agency said. The prescribing information includes a warning about these risks. The vaccine continues to be available under emergency use authorization (EUA), including for individuals ages 12 through 15 years.

An amended EUA for the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine allowing the use of an additional dose in certain immunocompromised individuals. This group includes solid-organ transplant recipients and those diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The additional third dose of these vaccines may be administered to such immunocompromised individuals ages 18 years or older (or those ages 12 years and older for the Pfizer-BioNTech vaccine) at least 28 days following the two-dose regimen of the same vaccine.

An amended EUA for the use of the monoclonal antibodies bamlanivimab and etesevimab, administered together. Use is now authorized only in states, territories, and U.S. jurisdictions in which recent data show the combined frequency of variants resistant to the drug combination is less than or equal to 5%.

A letter to clinicians alerting them to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacture Co. Ltd. The CDC's National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to the company because the firm did not implement, maintain, and control a quality management system. All previously authorized respirators by the company are no longer authorized for emergency use as a result of the loss of NIOSH-approval.

Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include dexamethasone sodium phosphate injection (4 mg/mL).

Approvals

The MicroTransponder Vivistim Paired VNS System to treat moderate to severe upper-extremity motor deficits associated with chronic ischemic stroke. The first-of-its-kind stroke rehabilitation system uses vagus nerve simulation (VNS) and may be used in both clinical and at-home settings. It is intended to be used with post-stroke rehabilitation therapy to reduce deficiencies in upper-limb and extremity motor function. A pulse generator, which generates a mild electrical pulse, is implanted just under the skin in the chest. Attached to this is a lead wire that is implanted under the skin and connects to electrodes placed on the left side of the neck. Accompanying the implant components are software and a wireless transmitter to be used only by a clinician. Safety and effectiveness of the prescription device were evaluated in a study of 108 patients at 19 clinical sites in the U.S. and U.K. who received the system. Patients were split into a study group (53 patients) and a control group (55 patients) and were asked to complete 300 to 400 physical therapy exercise movements for 90 minutes a day, three times a week for six weeks. Patients in the treatment group had greater improvements in motor functions. Adverse events included dysphonia, bruising, falling, general hoarseness, general pain, hoarseness after surgery, low mood, muscle pain, fracture, headache, rash, dizziness, throat irritation, urinary tract infection, and fatigue. The device should not be used in patients who have had vagotomy.

A new indication for calcium, magnesium, potassium, and sodium oxybates (Xywav) oral solution to treat adults with idiopathic hypersomnia. The orphan drug was already approved for the treatment of cataplexy or excessive daytime sleepiness in patients ages 7 years and older with narcolepsy. Effectiveness for the new indication was evaluated in a study of 154 patients ages 19 to 75 years with idiopathic hypersomnia. Those randomized to switch from the drug to placebo experienced worsening measures of sleepiness and symptoms of idiopathic hypersomnia compared to those randomized to continue treatment. The most common adverse events of the drug were nausea, headache, dizziness, anxiety, and vomiting. The drug carries a boxed warning for central nervous system depression and misuse. Oxybate, also known as gamma-hydroxybutyrate, is a Schedule I controlled substance, and misuse of illicit forms has been associated with serious side effects, such as seizures, trouble breathing, coma, and death. In addition, clinically significant respiratory depression and reduced level of alertness have occurred in adult patients taking sodium oxybate. Due to these risks, the drug is subject to strict safety controls on prescribing and dispensing under a Risk Evaluation and Mitigation Strategy.

Avalglucosidase alfa-ngpt (Nexviazyme) for IV infusion to treat patients ages 1 year and older with late-onset Pompe disease. The orphan drug helps reduce glycogen accumulation. Effectiveness was demonstrated in a study of 100 patients randomized to take the drug or another FDA-approved enzyme replacement therapy for the disease. Treatment with the medication improved lung function similarly to the improvement seen with the other therapy. The most common side effects included headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria. Serious reactions included hypersensitivity reactions, such as anaphylaxis, and infusion-associated reactions, such as respiratory distress, chills, and pyrexia. Patients susceptible to fluid-volume overload or those with compromised cardiac or respiratory function may be at risk for serious acute cardiorespiratory failure.

First generic drug approvals

Varenicline tablets (0.5 mg and 1 mg) for use as an aid to smoking cessation treatment. (Brand name: Chantix)

Paliperidone palmitate extended-release injectable suspension (39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL) for the treatment of schizophrenia and schizoaffective disorder in adults. (Brand name: Invega Sustenna)

Atropine sulfate injection USP (0.25 mg/5 mL [0.05 mg/mL], 0.5 mg/5 mL [0.1 mg/mL], and 1 mg/10 mL [0.1 mg/mL] in single-dose syringes) for the temporary blockade of severe or life-threatening muscarinic effects. (Brand name: None provided)

Potassium chloride in 5% dextrose and 0.225% sodium chloride injection USP (10 mEq/500 mL [1.49 mg/mL] and 20 mEq/1,000 mL [1.49 mg/mL] in single-dose containers) for the treatment of patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. (Brand name: None provided)

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