What We’re Reading: Ozanimod Label Updated; Mixing COVID-19 Vaccine Boosters; Gender-Affirming Hormone Therapy

AJMC Staff

The FDA releases label changes for ozanimod to treat multiple sclerosis; the National Institute of Allergy and Infectious Diseases initiated a study on mixing COVID-19 vaccines; gender-affirming hormones may affect the cardiovascular system.

FDA Updates Zeposia Label to Include New Safety Indications

The FDA’s Center for Drug Evaluation and Research has updated safety-related information for ozanimod hydrochloride (Zeposia), which is used to treat multiple sclerosis. Transient instances of bradycardia were reported in several studies upon treatment initiation, as were atrioventricular conduction delays. Details on both can now be found under “Warnings and Precautions.” Patients are recommended to consult with their cardiologist if they have QT prolongation greater than 450 msec for men or above 470 msec for women, if treatment with Zeposia is a possibility. Additional labels subsections updated include those for liver injury, increased blood pressure, respiratory effects, and macular edema.

NIAID Study Investigating COVID-19 Vaccines

Prolonging immunity and increased protection from COVID-19 are at the heart of a new study from the National Institute of Allergy and Infectious Diseases (NIAID), reports The Wall Street Journal. A principal aim of this study, whose participants will be fully vaccinated adults, is to head off variants of COVID-19 and optimize vaccine combination treatment if results indicate booster shots are needed, according to Anthony S. Fauci, MD, NIAID director. Booster shots are also a hot topic of discussion among transplant recipients, whose immunocompromised status may mitigate COVID-19 vaccine effectiveness.

Cardiovascular Risk Seen in Gender-Affirming Hormone Recipients

Findings from a study on 129 transgender individuals indicate possible adverse effects from gender-affirming hormone treatment, according to MedPage Today, specifically certain metabolic parameters. For example, high-density lipoprotein cholesterol levels dropped 2.5% each year among transgender males who received testosterone (P = .03) over the 4-year average follow-up. Low-density lipoprotein cholesterol, glycated hemoglobin, triglycerides, and 25-hydroxyvitamin D, meanwhile, were not significantly affected among any of the transgender females or males in the study.