Updated Ozanimod label; Mix the COVID-19 vaccine boosters; Gender affirming hormone therapy

FDA Issues Label Changes For Ozanimod To Treat Multiple Sclerosis; The National Institute of Allergies and Infectious Diseases has launched a study on the mixture of COVID-19 vaccines; gender-affirming hormones can affect the cardiovascular system.

FDA Updates Zeposia Label to Include New Safety Indications

FDA Drug Review and Research Center updated safety information of ozanimod hydrochloride (Zeposia), which is used to treat multiple sclerosis. Transient cases of bradycardia have been reported in several studies at the start of treatment, as have atrioventricular conduction delays. Details on both can now be found under “Warnings and Precautions”. Patients are recommended to consult their cardiologist if they experience QT prolongation greater than 450 ms for males or greater than 470 ms for females, if treatment with Zeposia is a possibility. Updated additional label subsections include those related to liver damage, increased blood pressure, respiratory effects, and macular edema.

NIAID COVID-19 Vaccine Study

Prolonging immunity and increased protection against COVID-19 are at the heart of a new study by the National Institute of Allergy and Infectious Diseases (NIAID), reports The Wall Street Journal. According to Anthony S. Fauci, MD, director of NIAID, one of the main goals of this study, whose participants will be fully vaccinated adults, is to avoid variants of COVID-19 and to optimize combination vaccine therapy if the results indicate that booster injections are needed. Booster shots are also a hot topic of discussion among transplant recipients, whose immunocompromised status may reduce the effectiveness of the COVID-19 vaccine.

Cardiovascular risk observed in gender-affirming hormone Recipients

Results from a study of 129 transgender people indicate possible side effects of gender-affirming hormone therapy, according to MedPage Today, in particular certain metabolic parameters. For example, high-density lipoprotein cholesterol levels fell 2.5% each year in transgender men who received testosterone (P = .03) during the mean follow-up of 4 years. Low-density lipoprotein cholesterol, glycated hemoglobin, triglycerides, and 25-hydroxyvitamin D, meanwhile, were not significantly affected in the transgender women or men in the study.


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Ethel Nester

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