BATON ROUGE, La., Oct. 25, 2018 (GLOBE NEWSWIRE) — The Food and Drug Administration (FDA) will amend the regulations for pediatric corticosteroid booster shots, acknowledging that clinical trial data suggest that several “cocktail” booster shots can be safely used in combination with existing shots. The new policy reflects the data showing an increased risk of drug-drug interactions with some combination treatments when used with dexamethasone therapy for leukemia and immune system disorders. This decision builds on the agency’s initial efforts to identify promising new classes of drugs for both childhood vaccination and cancer care.
The new policy means the use of thesedif-DSTS (see, 2016 decision approved use of “methyl-DHTS) pediatric booster shot regimen will be permitted. GSK, Genentech and AstraZeneca have partnered with Medimmune to develop this regimen, and they will now be able to submit applications to market the combination dose of hydrocortisone and dexamethasone to the FDA.
Millions of children get a corticosteroid shot in childhood to improve their immune system and prevent disease. Historically, booster shots were only administered by an a doctor or nurse trained in using corticosteroids. In 2006, the FDA released the “Dosage Management for Kids” decision allowing the issuance of adult dosages for use of corticosteroids, after receiving a large set of evidence showing increased risks of drug-drug interactions with certain combination treatments for conditions including cancer and leukemia.
Today’s decision is expected to save healthcare costs as well as reduce anesthesiologist workload and cut down the time required for patient visits, visit recoveries and other operational costs associated with new injection protocols. It should also allow children to receive a booster shot earlier, rather than waiting until they turn 18 to get a booster shot.