WASHINGTON, D.C. — The Food and Drug Administration unveiled a series of high-profile actions last week, ranging from a potential new therapy for autism symptoms to a landmark approval of eyeglasses designed to slow childhood nearsightedness.
On Sept. 22, the agency announced it is working with GlaxoSmithKline to expand the use of leucovorin calcium (marketed as Wellcovorin) for patients with cerebral folate deficiency, a rare neurological disorder often associated with autistic features. FDA officials cited more than a decade of published data showing the drug may improve developmental delays, seizures, and behavioral challenges in children with the condition.
That same day, the FDA revealed it will move to add a warning label to acetaminophen, better known as Tylenol, following evidence of a possible link between the drug’s use during pregnancy and higher rates of autism and ADHD in children. Officials stressed that the studies show association, not causation, but urged caution while reaffirming acetaminophen remains the only over-the-counter fever reducer considered safe during pregnancy.
Later in the week, regulators lifted the special safety program tied to Caprelsa, a thyroid cancer drug first approved in 2011. After more than a decade of monitoring, FDA data showed no major heart rhythm complications, allowing the agency to remove mandatory restrictions while keeping the medicine on the market.
Finally, in a move hailed by pediatric specialists, the FDA authorized the first eyeglass lenses to slow the progression of myopia in children ages 6 to 12. Essilor Stellest lenses use a ring of tiny lenslets to alter peripheral light, reducing eye elongation that leads to worsening nearsightedness. A two-year clinical trial showed the lenses cut myopia progression by more than 70 percent compared with standard glasses.
The cluster of announcements underscores the agency’s growing focus on repurposed drugs, maternal health, and new devices that address widespread chronic conditions from early childhood through adulthood.
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