FDA UPDATES SOTROVIMAB EMERGENCY USE AUTHORIZATION – UPDATE [3/25/2022] FDA LIMITS USE OF SOTROVIMAB TO TREAT COVID-19 IN SOME U.S. REGIONS DUE TO THE BA.2 OMICRON SUB-VARIANT
This statement updates and replaces the original statement from 2/25/2022.
Considering the most recent data available, FDA is announcing that sotrovimab is no longer authorized for use at this time in the following states and territories: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (HHS Region 1). New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2) New data included in the health care provider fact sheet shows that the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Full Access: FDA
COVID-19 CASES AND DISEASE SEVERITY IN PREGNANCY AND NEONATAL POSITIVITY ASSOCIATED WITH DELTA (B.1.617.2) AND OMICRON (B.1.1.529) VARIANT PREDOMINANCE
prospectively studied pregnant patients diagnosed with SARS-CoV-2 infection at Parkland Health, an urban prenatal system encompassing a centralized acute care hospital and 10 community-based prenatal clinics around Dallas, Texas. Of the 2641 cases, 112 (4.2%) were severe or critical. These included 53 (4.1%) severe or critical cases pre-Delta (0 vaccinated), 51 (11.8%) during Delta (2 vaccinated), and 8 (0.9%) during Omicron (2 vaccinated). Delta variant predominance was associated with increased illness severity and Omicron with decreased illness severity after adjusting for prior vaccination. The majority of early neonatal SARS-CoV-2 infections occurred among unvaccinated mothers with non-severe COVID-19. Long-term risks of early neonatal SARS-CoV-2 infection are unknown, but maternal vaccination may be protective. Full Access: JAMA
ORPHENADRINE RECALLED DUE TO POSSIBLE NITROSAMINE IMPURITY
Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets.
The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021. Full Access: JAMA
TICK-BORNE HEARTLAND VIRUS CIRCULATING IN US, RESEARCHERS SAY
The Heartland virus is circulating in lone star ticks in Georgia, according to a new study published in the journal Emerging Infectious Diseases. The virus, which was first identified in Missouri in 2009, has been documented in several states across the Southeast and Midwest. There have been more than 50 cases in people from 11 states. Symptoms can be fever, fatigue, diarrhea, muscle pain, and low counts of white blood cells and platelets. It can take up to 2 weeks for symptoms to appear after a bite from an infected tick. Full Access: Medscape
