Alert on increased risk of serious cardiovascular events and cancer with Xeljanz
The FDA is alerting the public that preliminary results of a safety trial show an increased risk of serious cardiovascular events and cancer associated with the use of tofacitinib (Xeljanz, Xeljanz XR) compared with tumor necrosis factor (TNF) inhibitors. The alert is based on data from a clinical safety study in patients with rheumatoid arthritis (RA) who were taking methotrexate to evaluate the risk of serious cardiovascular events, cancer, and infections.
The trial studied tofacitinib 5 mg twice daily (the approved dosage for RA) and a higher 10 mg twice-daily dosage in comparison to a TNF inhibitor. Patients in the trial were at least 50 years old and had at least one cardiovascular risk factor. In 2019, the FDA warned that interim study results showed an increased risk of blood clots and death with the higher 10 mg twice-daily dosage. As a result, the agency added a boxed warning to tofacitinib's prescribing information. The FDA will communicate its final conclusions and recommendations when the review is completed.
Healthcare providers should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue the medicine for their patients.
CDC updates recommended immunization schedule for adults in 2021
The CDC's Advisory Committee on Immunization Practices (ACIP) updated its recommended immunization schedule for adults 19 years of age or older for 2021. The recommendations for 2021 are largely the same as for 2020, but this year there is a section on vaccination during the pandemic as well as interim recommendations on administering the Pfizer-BioNTech and Moderna coronavirus disease 2019 (COVID-19) vaccines.
ACIP recommends use of COVID-19 vaccines within the scope of the Emergency Use Authorization or Biologics License Application for the particular vaccine.
Vaccine-specific changes in the 2021 immunization schedule for adults 19 years of age and older include new or updated ACIP recommendations for influenza; hepatitis A; hepatitis B; human papillomavirus; pneumococcal; meningococcal serogroups A, C, W, and Y; meningococcal B; and zoster vaccines.
Rapivab receives expanded approval for younger patients with influenza
The FDA approved an expanded indication for peramivir injection (Rapivab) to include treatment of acute uncomplicated influenza in patients 6 months of age and older who have been symptomatic for no more than 2 days. Prior to this expanded approval, peramivir was indicated for patients 2 years of age and older.
Rapivab's efficacy is based on clinical trials of naturally occurring influenza, in which the predominant influenza infections were influenza A virus; only a limited number of subjects infected with influenza B virus were enrolled in the studies.
FDA approves EUA for COVID-19 treatment with monoclonal antibodies
The FDA issued an emergency use authorization (EUA) for Eli Lilly's monoclonal antibodies bamlanivimab and etesevimab administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg [88 lb]) who test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and who are at high risk for progressing to severe COVID-19. The EUA includes treatment for adults 65 years of age and older and those who have certain chronic medical conditions. However, the treatment is not approved for patients who are hospitalized due to COVID-19 or for those who require oxygen therapy due to COVID-19.
In a clinical trial of patients with COVID-19 at high risk for disease progression, a single I.V. infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared with placebo.