FDA approves new restrictions on COVID-19 vaccines

Recalls and warnings

Updated use instructions for all lots of certain Watchman access systems due to risk of air embolisms when procedures are performed without positive pressure-controlled ventilation. There have been 120 serious injuries and 17 deaths associated with this issue.

An alert that expanded polytetrafluoroethylene-coated coils in certain Endotak Reliance defibrillation leads may impact shock efficacy and/or require early replacement. There have been 386 serious injuries and 16 patient deaths associated with this issue.

A class I recall of Philips Respironics, Inc.'s, V30, A30, and A40 ventilators due to the risk for a failure in the ventilator inoperative alarm, which can cause therapy interruption or loss. There have been 13 reported injuries and eight reported deaths.

An alert that certain Abiomed automated Impella controllers have a pump driver circuit assembly that does not meet current specifications. In the case of capacitor failure in the automated controller, an abrupt pump stoppage or decreased performance may occur. There has been one death reported.

A voluntary medical device correction from Tandem Diabetes Care, Inc., for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. There have been 700 confirmed adverse events, defined as a confirmed high blood glucose level and/or an event requiring medical intervention, and 59 reported injuries.

An alert that all Novum IQ large-volume pumps (LVP) and Novum IQ syringe pumps (SP) from Baxter be corrected prior to continued use due to software anomalies that may result in a blank run screen (LVP and SP) and/or false motor movement system error (SP only). There have been three reports of serious injuries.

A recall of certain left heart vent catheters from Medtronic based on reports that they have resisted shape retention when being bent. The company has reported three serious injuries.

A class I recall of SafeStar and TwinStar breathing system filters by Draeger due to the risk of misleading capnography readings. Serious injuries due to the slow increase of carbon dioxide curve when using the sampling port of the filter have been reported.

A recall of certain Medline ReNewal reprocessed St. Jude medical response diagnostic electrophysiology catheters and supreme electrophysiology catheters because they may contain small residual particulates.

A recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene products by DermaRite Industries due to Burkholderia cepacia contamination.

A recall by B. Braun Medical Inc. of two lots of lactated ringer injection USP, 1,000 mL, and 0.9% sodium chloride injection USP, 1,000 mL, due to the presence of particulate matter inside the container.

A class I recall of carotid WALLSTENT monorail endoprosthesis by Boston Scientific due to a manufacturing defect that created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system. In six reported cases, additional intervention was required to recover the device.

A recall of one lot of cyclobenzaprine hydrochloride tablets USP, 10 mg, by Unichem Pharmaceuticals (USA), Inc., due to inadvertent placement of the cyclobenzaprine 10-mg (90-ct) label on a bottle containing 7.5-mg meloxicam tablets.

Miscellaneous

Labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. The changes will include clearer risk information, dosing warnings, clarified use limits, treatment guidance, information on safe discontinuation, overdose reversal agents, drug interactions, and risks associated with overdose and digestive health. The FDA is also requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use.

A letter to health care professionals and facilities about the safe use of hyperbaric oxygen therapy devices and the importance of following the manufacturer's instructions for use. The FDA is aware of recent reports of fires that resulted in serious injuries and deaths.

An announcement that the nationwide shortage of sodium chloride 0.9% injection products has officially ended.

A suspension of the biologics license for Valneva Austria GmbH's chikungunya vaccine (Ixchiq) by the FDA's Center for Biologics Evaluation and Research, based on serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients. The announcement comes after the FDA lifted a recommended pause in the use of the chikungunya vaccine in individuals ages 60 years and older.

Approvals

New marketing authorizations for COVID-19 vaccines, limiting approval to adults ages 65 years and older and children and adults with at least one medical condition that puts them at risk of severe illness. FDA also revoked emergency use authorizations for the vaccines.

Zopapogene imadenovec-drba (Papzimeos), a first-of-its-kind nonreplicating adenoviral vector-based immunotherapy for the treatment of adults with recurrent respiratory papillomatosis. The treatment received an orphan-drug designation and is administered via subcutaneous injection. A single-arm open-label trial found that 51.4% of patients achieved a complete response, defined as no need for surgical intervention in the 12 months following treatment. Most treatment-emergent adverse events were mild to moderate. No dose-limiting toxicities were observed, and no treatment-related serious adverse events were reported.

Accelerated approval of dordaviprone (Modeyso), a protease activator, for patients one year of age and older with diffuse midline glioma harboring an H3 K27M mutation who have progressive disease following prior therapy. It is the first FDA approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma. The treatment received an orphan-drug designation. Results of five open-label, nonrandomized clinical trials showed an overall response rate of 22% and a median duration of response of 10.3 months. Prescribing information includes warnings and precautions for hypersensitivity, QTc interval prolongation, and embryo-fetal toxicity.

Accelerated approval of zongertinib (Hernexeos), a kinase inhibitor, for adults with unresectable or metastatic nonsquamous non-small-cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD)-activating mutations and who have received prior systemic therapy. The FDA also approved the Oncomine Dx target test as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD-activating mutations in patients with nonsquamous NSCLC who may be eligible for treatment with zongertinib. The prescribing information for zongertinib includes warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

First-time generic drug approvals

Methohexital sodium for IV induction of anesthesia prior to the use of other general anesthetic agents. (Brand name: Brevital)

Paclitaxel, for metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. (Brand name: Abraxane)

Ephedrine sulfate injection, for treatment of clinically important hypotension occurring in the setting of anesthesia. (Brand name: Akovaz)

Minocycline for injection, for the treatment of infections due to susceptible isolates of the designated bacteria. (Brand name: Minocin)

Cyclophosphamide injection, for the treatment of malignant diseases.

Ciprofloxacin otic solution, for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus. (Brand name: Cetraxal)

Chromic chloride injection USP, for use as a supplement to IV solutions given for total parenteral nutrition.

Exenatide injection USP, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. (Brand name: Byetta injection)

Aripiprazole for extended-release injectable suspension, for the treatment of schizophrenia in adults. (Brand name: Abilify Maintena)

Baclofen oral solution, for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. (Brand name: Ozobax)

Raltegravir tablets USP, for the treatment of HIV-1 infection in adult patients. (Brand name: Isentress)

Liraglutide injection, as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes. (Brand name: Victoza)

Prucalopride tablets, for the treatment of chronic idiopathic constipation in adults. (Brand name: Motegrity)

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