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Around the Web — 4.18.23

The emerging SARS-CoV-2 subvariant XBB.1.16 may carry the previously rare symptom of conjunctivitis, according to a pediatrician in India and a news report in the San Francisco Chronicle. A member of the WHO Vaccine Safety Net Program, Vipin M. Vashishtha, MD, describes an infantile phenotype of treated infants with high fever, cough and cold, and nonpurulent, itchy conjunctivitis with sticky eyes. The spread of the subvariant — also called Arcturus — has prompted India to reinstitute mandatory masking and resume vaccine production. After discussions with FDA, the CDC Advisory Committee on Immunization Practices scheduled a special virtual meeting on April 19 to discuss anticipated regulatory changes to the COVID-19 vaccination program.

FDA yesterday approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) for use in adult and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Availability of the product increases access to stem cell transplants for patients from racially or ethnically diverse backgrounds who struggle to find a fully matched donor in the registry, the company said. Patients who are Black or African American have just a 29% chance of finding a match via the donor registry vs. a 79% chance for patients who are White.

FDA last week provided additional guidance on the use of prescribing information for opioid pain medicines. Although the number of dispensed prescriptions for opioid pain medicines has decreased substantially, FDA said that overdose deaths involving prescription opioids have remained steady. The agency emphasizes that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; patients who use opioid pain medicines after surgery often have unused tablets, and these pose a risk of accidental use, misuse and abuse, addiction, and overdose, including by children and teenagers; and extended-release/long-acting opioid pain medicines have unique risks and should be used only for those with severe and persistent pain. FDA has also determined that a new warning is needed about opioid-induced hyperalgesia (OIH), which is when an opioid prescribed and taken for pain relief causes an increase in pain or increased sensitivity to pain (allodynia). Although OIH can occur at any opioid dosage, it may occur more often with higher doses and longer-term use. This condition can be difficult to recognize and may result in increased opioid dosages that could worsen symptoms and increase the risk of respiratory depression, the agency noted.