Nonopioid treatment for moderate to severe pain approved

Recalls and warnings

A safety labeling change to the prescribing information for Abrysvo (respiratory syncytial virus [RSV] vaccine) manufactured by Pfizer Inc. and Arexvy (RSV vaccine, adjuvanted) manufactured by GlaxoSmithKline Biologicals, requiring each manufacturer to include a new warning about the risk for Guillain-Barré syndrome following administration of their vaccines.

A boxed warning added to glatiramer acetate (Copaxone), a multiple sclerosis medication, due to the rare risk of anaphylaxis that can occur at any time while on treatment. For most people who experienced anaphylaxis, the symptoms appeared within one hour of injection. Clinicians should be aware that fatal anaphylaxis has occurred and that the symptoms may overlap with those of common immediate post-injection reactions. Between December 1996 and May 2024, 82 cases have been reported worldwide, six of which resulted in death.

A class I recall by Philips and their subsidiary to correct the monitoring service application related to mobile cardiac telemetry monitoring (BTPS-1000), after some electrocardiographic events received were not properly routed and thus not reviewed by a cardiology technician for potential reporting to the ordering clinician. The FDA is aware of 109 reported injuries and two reports of death related to this issue.

A class I recall updating use instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH systems by Getinge and Maquet Cardiovascular due to two possible sources of failure during use: a bent or detached heater wire and silicone peeling or detaching from the jaws of the harvesting tool. There have been seven reported serious injuries and no deaths.

A class I recall from Nova Biomedical to correct StatStrip glucose and glucose/ketone hospital meters due to a software error that may cause incorrect glucose and/or ketone patient test results to be transmitted to hospital medical record systems. The issue may affect all historical test results before the meters are updated to v.0.0.13.45 software. There have been no reported injuries.

A class I recall of the Neo-Tee T-piece resuscitator by Mercury Medical due to a small spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. This issue could reduce positive pressure and may cause serious adverse health consequences, including desaturation, bradycardia, hypoxia, hypercarbia, and death. There have been no reported injuries.

An alert that Nuwellis has issued a letter recommending that certain lots of AquaFlexFlow UF 500 plus extracorporeal blood circuits be removed from use related to a potentially high-risk device issue. The circuit may indicate “Ultrafiltrate Weight Mismatch” or “Excessive Weight Mismatch” alarms while in use. Too many weight mismatch alarms will terminate therapy with that blood circuit. Three injuries have been reported by the manufacturer.

An alert that Medline has issued a letter recommending certain lots of fluid delivery sets with drip chamber within Medline custom kits be removed from use. Some fluid delivery sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. Using a fluid delivery set with this incorrect component increases the risk of over-administration of fluids, which may result in swelling, shortness of breath, increased blood pressure, and/or death. No injuries have been reported.

An alert that Baxter Healthcare Corporation has issued a letter recommending that certain lots of solution sets with duo-vent spikes be removed from use. Some sets with duo-vent spikes were incorrectly assembled with inverted slide clamps. The company has not reported any injuries associated with this issue.

An alert that Fresenius Kabi USA has issued a letter recommending certain software versions of the Ivenix infusion system be updated related to a potentially high-risk device issue. No injuries have been reported.

A warning not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC in Largo, Fla., and Endo USA in Malvern, Pa. Clinicians have confused these products with FDA-approved injectable epinephrine products for IV use. These nasal solution products should never be injected intravenously. In December 2024, Endo USA voluntarily recalled its unapproved adrenalin chloride solution (epinephrine nasal solution, USP) due to the potential for accidental injection of the nasal solution instead of the injection product.

A safety communication that cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors (which are Contec CMS8000 patient monitors relabeled as MN-120) may put patients at risk after being connected to the internet. These cybersecurity vulnerabilities can allow unauthorized actors to bypass cybersecurity controls, gaining access to and potentially manipulating the device. The FDA is not aware of any cybersecurity incidents, injuries, or deaths related to these cybersecurity vulnerabilities at this time.

A class I recall correcting Baxter's AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. Baxter is in the process of evaluating whether the source of PCBAs and/or NDL PCBs in those recalls is present in AK 98 dialysis machines. The use of affected products may cause serious adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems, male infertility, and death. There have been no reported injuries and no reports of death. A class I recall has also been issued for Baxter's MiniCap extended life PD transfer sets for the same reason. There have been no reported injuries related to this recall.

Approvals

Suzetrigine (Journavx), 50-mg oral tablets, a first-in-class nonopioid analgesic, to treat moderate to severe acute pain in adults. The drug targets a pain-signaling pathway involving sodium channels in the peripheral nervous system. Efficacy was evaluated in two trials, both of which demonstrated a statistically significant superior reduction in pain with suzetrigine compared to placebo. Safety is primarily based on data from trials in patients with moderate to severe acute pain following abdominoplasty and bunionectomy. The most common adverse reactions were itching, muscle spasms, increased blood levels of creatine phosphokinase, and rash.

Sotorasib (Lumakras) with panitumumab (Vectibix) for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The FDA also approved the therascreen KRAS RGQ PCR kit as a companion diagnostic device to aid in identifying patients with colorectal cancer whose tumors harbor KRAS G12C mutations and who may be eligible for sotorasib and panitumumab. Results of a randomized controlled trial showed that median progression-free survival was 5.6 months in patients who received 960 mg of sotorasib plus panitumumab and 2 months in those who received standard therapy (trifluridine/tipiracil or regorafenib). Common adverse reactions included rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain. The treatment received an orphan-drug designation.

Acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle-cell lymphoma who are ineligible for autologous hematopoietic stem-cell transplantation. The FDA also approved acalabrutinib as a single agent for adults with previously treated mantle-cell lymphoma. A randomized controlled trial found that progression-free survival was statistically significantly longer in the acalabrutinib arm than the placebo arm, with a median follow-up of 49.8 months. Serious adverse reactions occurred in 69% of patients with acalabrutinib plus bendamustine and rituximab, and fatal adverse reactions occurred in 12%. The treatment received an orphan-drug designation.

Ensartinib (Ensacove) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor. Efficacy was evaluated in an open-label trial in 290 patients randomized 1:1 to receive ensartinib or crizotinib. Ensartinib demonstrated a statistically significant progression-free survival improvement compared to crizotinib with a hazard ratio of 0.56. The median progression-free survival was 25.8 months in the ensartinib arm and 12.7 months in the crizotinib arm. Common adverse reactions included rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue.

Durvalumab (Imfinzi) for adults with limited-stage small-cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. A placebo-controlled trial found durvalumab demonstrated a statistically significant overall survival improvement compared to placebo (median, 55.9 months vs. 33.4 months) and a statistically significant progression-free survival improvement compared to placebo (median, 16.6 months vs. 9.2 months, respectively). Common adverse reactions included pneumonitis or radiation pneumonitis and fatigue.

Marketing authorization of 20 ZYN nicotine pouch products through the premarket tobacco product application pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person's gum and lip. The FDA's evaluation showed that due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose lower risk of cancer and other serious health conditions than such products.