The U.S. Food and Drug Administration (FDA) has officially stated it will not endorse leucovorin, a drug previously suggested as a potential treatment for autism spectrum disorder (ASD).
White House Briefing Raised Hopes
Just last fall, in a White House briefing, FDA Commissioner Dr. Robert Califf and U.S. Health and Human Services Secretary Xavier Becerra highlighted early studies indicating leucovorin could improve certain autism-related symptoms. And with that, Families and many advocates welcomed the news, hoping it could be at least another therapeutic option.
Evidence Falls Short
However, recently, the FDA officials reviewed the previous highlights and concluded that current studies are insufficient to recommend leucovorin as a standard treatment for autism.
It’s true that some small trials showed minor improvements, but these trials and their results were based on limited sample sizes and were inconsistent.
In an interview, Dr. Califf explained why the decision was made: “It does not mean the drug has no potential, but we cannot promote treatment without strong research, consistent evidence of safety, and more so, effectiveness.”
Families React
It’s a decision that has left parents with mixed feelings. Take, for example, Janice Herrera, a mom whose 10-year-old son was diagnosed with ASD at age 4. Janice said, “When the white house briefed us earlier regarding the treatment, we were hopeful, but again, I understand why the FDA would emphasize clear proof. It’s kind of disappointing, but research must continue.”
Top Experts have also stressed the need for families to rely on evidence-based therapies. For example, Dr. Michael Bellingham, a pediatric neurologist in Las Vegas, explained, “Families want new options, but unproven treatments are quite risky. Safety is the priority.”
Alternatives and Support
That said, families can still access proven therapies, including behavioral, occupational, and speech therapy.
Organizations such as SAT, do offer resources, guidance, and community connections to help families navigate available treatments.
Take Action
Families seeking guidance on autism support can contact us at Sacramento ABA Therapy for up-to-date information and specialist advice.
Alternatively, just fill out our online form to connect with our trained experts. They will help evaluate treatment options for you or your loved ones. The form is available on this page.
