The U.S. Food and Drug Administration (FDA) has been active over the past few months, approving new vaccines and treatments while also issuing recalls and updates for various medical devices used in critical care. These actions impact the landscape of pulmonology and critical care medicine, addressing both infectious diseases and device safety.
Sirturo (Bedaquiline) Receives Traditional Approval for Tuberculosis Treatment
Sirturo (bedaquiline), a diarylquinoline antimycobacterial, received traditional FDA approval on June 21 for use in combination therapy for pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis resistant to rifampin and isoniazid. The approval extends to adults and children aged 5 years and older, weighing at least 15 kg. Originally granted accelerated approval in 2012, the traditional approval is based on data from the Phase 3 STREAM study (NCT02409290), which confirmed the drug's clinical benefit. Sirturo must be used with at least three other drugs to which the TB isolate is susceptible. Dosage for adults is 400 mg once daily for 2 weeks, followed by 200 mg three times per week for 22 weeks, with pediatric dosage based on body weight. The drug is contraindicated with strong CYP3A4 inducers, and caution is advised when co-administered with CYP3A4 inhibitors due to potential liver function impacts.
mResvia Approved for RSV Prevention
The FDA approved mResvia, an mRNA-based vaccine, on May 31 for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 years and older. Each 0.5 mL dose contains 50 mcg of nucleoside-modified mRNA encoding the RSV F glycoprotein. The vaccine induces an immune response against the RSV pre-F protein, protecting against LRTD. It is administered as a single 0.5 mL intramuscular injection via a prefilled syringe, which must be thawed before use. The vaccine is contraindicated in patients with a history of severe allergic reaction to any of its components.
Capvaxive Approved for Pneumococcal Pneumonia Prevention
On June 17, the FDA approved Capvaxive, a pneumococcal 21-valent conjugate vaccine, for active immunization against invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older. The vaccine consists of pneumococcal polysaccharides from 21 serotypes, including eight unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B). The pneumonia indication received accelerated approval based on immune responses measured by opsonophagocytic activity. It is administered as a single 0.5mL intramuscular injection. The vaccine is contraindicated in patients with severe allergic reactions to any component of Capvaxive or to diphtheria toxoid.
Medical Device Recalls and Updates
The FDA also issued several recalls and updates for medical devices, including:
- Ivenix Infusion Pump Sets: Fresenius Kabi USA recalled certain Ivenix large volume pump primary administration sets due to potential uncontrolled medication flow, which could lead to overdose and death. Two injuries were reported.
- RMU-2000 ARM XR Chest Compression Device: Defibtech, LLC recalled the RMU-2000 ARM XR chest compression device due to a motor problem that may cause it to stop compressions, potentially leading to serious adverse health consequences. One death and one injury were reported.
- Volara System Single Patient Use Circuit and Blue Ventilator Adapter: Baxter Advanced Respiratory recalled lung therapy components of the Volara System due to reports of handset plug disconnection, which could lead to insufficient ventilation and severe health consequences. No injuries or deaths were reported at the time of the recall.
- Infusomat Space Infusion Systems: B. Braun Medical Inc. issued a correction for certain infusion pumps with faulty occlusion alarms, advising against their use for delivering high-risk medications. One injury and one death were reported.
- ClotTriever XL Catheter: Inari Medical updated usage procedures for the ClotTriever XL Catheter due to reports of patient injury and death from device entrapment and pulmonary emboli. The FDA advised against using the device for removing fibrous or calcified material.
- Plum 360, Plum A+ and Plum A+3 Infusion Systems: ICU Medical updated battery-related use instructions for these infusion systems due to a manufacturing defect causing reduced battery life, potentially affecting infusion delivery.
- Vivo 45 LS Ventilator: Breas Medical updated use instructions for the Vivo 45 LS ventilator due to the potential for a short-term increase in formaldehyde exposure for patients using new devices for the first time. The FDA directed users to pre-run new devices for 14 days before patient use and to maintain a maximum room air temperature of 30°C.
