What You Should Know About Autism and Medications

Autism spectrum disorder is a developmental disability. People on the autism spectrum have varied abilities and support needs. Some may have advanced conversation skills and can live with minimal  support, whereas others may use few to no words and require 24/7 care.

Autism has been in the headlines recently. On Monday, September 22, the U.S. Food and Drug Administration (FDA) took two steps that drew widespread interest and prompted criticism from a number of medical and science organizations.

  • The agency alerted physicians that the use of acetaminophen, the active ingredient in the pain reliever Tylenol and other generic medications, by pregnant women may be associated with an increased risk of neuropsychiatric conditions, including autism. The FDA said clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers, which is already the existing guidance.
  • The agency took steps to make it easier for clinicians to prescribe an older medication, leucovorin, or folinic acid (a naturally occurring form of vitamin B9), to treat children with autism.

The actions by the federal government prompted many to seek answers. Here are answers to some of the most frequently asked questions from experts at the Icahn School of Medicine at Mount Sinai: Joseph Buxbaum, PhD, Director of the Seaver Autism Center for Research and Treatment; Joanne Stone, MD, Chair of Obstetrics, Gynecology and Reproductive Science; Lisa Satlin, MD, Chair of Pediatrics; and Alex Kolevzon, MD, Chief, Division of Child and Adolescent Psychiatry.

How common is autism?

The rate of autism in children increased over recent years and is now estimated to be 1 in 31, according to the latest monitoring data released in April by the U.S. Centers for Disease Control and Prevention. The survey was conducted in 2022 across 16 sites in the United States, and cases were identified based on school and medical records. Autism occurs among all racial, ethnic, and socioeconomic groups. It is three times more common among boys than among girls. Experts say a number of factors have contributed to a rising rate of autism, including expanded criteria for diagnosis, greater awareness, and improved screening and diagnostics.

What causes autism?

There are strong data indicating that genetics are the major cause of autism. However, not all genetic risk is inherited; some genetic changes leading to autism occur as spontaneous mutations in the egg or sperm, according to Mount Sinai’s Seaver Autism Center for Research and Treatment. Experts also believe some environmental factors may be involved.

What do you advise women about using acetaminophen during pregnancy?

The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to recommend acetaminophen as one of the safest options for treating pain and reducing fever during pregnancy when used as directed and emphasize that pregnant patients should always discuss any medication use with their clinicians. The FDA says acetaminophen is the safest over-the-counter alternative for pregnant women. It is also well documented that an untreated high fever in a pregnant woman increases the risk of birth defects and premature birth, and there is some suggestive evidence that fever in a pregnant woman may also be associated with an increased risk for autism in the child.

Did a recent Mount Sinai study demonstrate a connection between acetaminophen and autism?

Researchers at the Icahn School of Medicine at Mount Sinai, together with national collaborators, published a systematic review in BMC Environmental Health examining the use of acetaminophen during pregnancy. The research applied a rigorous framework for evaluating environmental health data and analyzed 46 studies involving more than 100,000 participants worldwide. The study found an association, but not a causal link, between prenatal acetaminophen exposure and an increased risk of autism spectrum disorder and attention-deficit/hyperactivity disorder in children. As the authors note, these do not prove that acetaminophen use during pregnancy causes these conditions. In fact, several large studies, including one that came out after the BMC Environmental Health study, indicate that acetaminophen does not cause these conditions and that there is likely a shared relationship between the reason acetaminophen is taken and the risk for behavioral outcomes in the child (for example, fever). Careful clinicians and researchers will continue research to optimize management of pain and fever during pregnancy using current or future medications but results to date do not demonstrate a causal relationship.

Can you explain the difference between association and causality?

Association is when two things happen at the same time, but one doesn’t necessarily cause the other. In a very simple example, more people eat ice cream in the summer, and more people get sunburns in the summer, but that doesn’t prove ice cream causes sunburns. There is an independent cause for both more sunburns and more ice cream in the summer: both are due to the warmer weather. In the case of autism, here is an example cited by the Autism Science Foundation: Women take acetaminophen when they are pregnant to reduce fever. Fever during pregnancy is a known autism risk factor. But this question remains unanswered: Could an increase in autism be due to the fever or the acetaminophen? At least one study showed that fever during pregnancy indeed increased risk for autism and that risk was significantly reduced when the mother took acetaminophen.

What are the treatments for autism?

The Seaver Autism Center for Research and Treatment says treatments include intensive behavioral and educational therapies and possibly medications. Many children benefit from a multidisciplinary team that may include board certified behavior analysts, speech and language pathologists, occupational therapists, physical therapists, and other professionals. It’s important to recognize that autism is a spectrum, and not all individuals or families view support through the lens of “treatment.” For many, the focus is on providing tools and accommodations that help autistic people thrive, while also celebrating their unique strengths and differences.

What do we know about leucovorin, which has recently been suggested as a treatment for autism?

The data suggesting that leucovorin may improve some symptoms of autism come from five small clinical trials. The Autism Science Foundation says a higher standard of science would be needed to determine if leucovorin is an effective and safe treatment for autism. The Foundation says the science is still in very early stages, and more studies are necessary before a definitive conclusion can be reached. As with all research in this field, experts emphasize that interventions should be considered in the context of each individual’s needs, and that supporting quality of life and respecting neurodiversity remain central priorities.

What about other research into autism?

Autism research is being conducted across many areas, including genetics, neurobiology, behavioral interventions, and targeted medications. One promising area of research seeks to identify autism genes in order to develop new medications, according to the Seaver Center. Some of the most exciting advances in autism are tests of new treatments tailored to the genetics of the patient.

What should I do if I think my child may have autism?

First, have a conversation with your child’s pediatrician. The American Academy of Pediatrics recommends that all children be screened for autism at their 18-month and 24-month well-child checkups. If there are concerns, your pediatrician should refer you to a specialist for a more extensive evaluation. The Seaver Autism Center is one important resource for our families.

Mount Sinai Queens Performs Its First-Ever Iliac-Branch Endovascular Aortic Repair Using Fixed Imaging

Patient Najib Saoui with Christopher Smolock, MD, left, and John Phair, MD

Mount Sinai Queens has achieved a milestone in surgical innovation with the successful completion of its first iliac-branch endovascular aortic repair (IBE)—a complex, minimally invasive procedure to treat an abdominal aortic aneurysm and iliac artery aneurysm—performed for the first time using fixed imaging in the hospital’s newly equipped operating room.

The groundbreaking procedure was successfully completed by vascular surgeons Christopher Smolock, MD, and John Phair, MD, and marks a significant advancement in the hospital’s ability to offer comprehensive vascular interventions that previously required transferring patients to Manhattan campuses.

Najib Saoui’s aneurysm was discovered incidentally during a CT scan, It had no symptoms and was monitored closely for several years. When the aneurysm reached a size that required intervention, the care team at Mount Sinai Queens was able to offer a state-of-the-art solution close to home.

In the procedure, aneurysms are treated by re-lining them with a covered stent, inserted through a small catheter in both groin arteries. This minimally invasive approach prevents the arteries from continuing to enlarge while preserving blood flow through the major artery branches to the abdomen and pelvis.

“This was a more technically complex repair,” Dr. Smolock says, “but with the advanced capabilities of our fixed imaging suite, we were able to perform the entire procedure on Mr. Saoui through a minimally invasive approach by accessing the artery from inside while preserving critical arterial branches to the pelvis.”

The two-hour procedure was a success, and Mr. Saoui was discharged the next day with no postoperative restrictions, able to resume normal activities without any limitations. This is a stark contrast to traditional open aortic surgery, which often involves a lengthy hospital stay and recovery period.

“This is a perfect example of how we’re expanding access to advanced surgical care in Queens, which has tripled over the past two years” Dr. Phair says. “Patients don’t need to travel to Manhattan to get the same high-quality, leading-edge treatment.”

All aortic aneurysms—whether treated or untreated—require lifelong monitoring. The patient will be followed with routine CT scans and ultrasounds, beginning one month after surgery and then annually, to ensure the repair remains functional. In some cases, additional maintenance procedures may be needed down the road, but those too are minimally invasive with virtually no downtime.

This case exemplifies Mount Sinai Queens’ ongoing commitment to bringing world-class surgical expertise and technology to the local community, the physicians said, enabling patients to receive exceptional, personalized care without leaving their borough.

 

Here’s What You Need to Know About the New COVID-19 Vaccines

As new variants of COVID-19 emerge, COVID-19 vaccines are updated to remain effective. This year’s formulations were approved by the Food and Drug Administration (FDA) with narrower eligibility, and an advisory committee of the Centers for Disease Control and Prevention (CDC) issued new recommendations for who should receive them.

However, while the federal guidance is different from last year, the advice from medical professionals hasn’t changed, says Bernard Camins, MD, MSc, Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai. “It’s a good idea for everyone to get the COVID-19 vaccine, because data shows it prevents severe disease and still saves lives.”

In New York State, and many other states across the nation, the state government and public health agencies have taken steps to ensure anyone who wishes to receive a COVID-19 vaccine will be able to do so.

If you’re thinking of getting a COVID-19 shot, Dr. Camins explains what you should know about them.

Bernard Camins, MD, MSc, Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai

What are the new COVID vaccines and their label restrictions?

Vaccines are available from the manufacturers Pfizer-BioNTech, Moderna, and Novavax. These have been tested in clinical trials to be safe and effective, as with previous versions, says Dr. Camins.

Here are the details of each approved vaccine.

  • Pfizer-BioNTech’s Comirnaty: It is available to adults 65 years and older, and to people ages 5 through 64 with at least one underlying condition that puts them at high risk for severe outcomes with COVID-19.
  • Moderna’s Spikevax and mNEXSPIKE: Spikevax is approved for those 65 years and older, and for people six months through 64 years old with at least one underlying condition that puts them at high risk for severe outcomes. The new mNEXSPIKE vaccine is approved for those 65 years and older, and for people ages 12 through 64 with at least one underlying condition that puts them at high risk.
  • Novavax’s Nuvaxovid: It is approved for those 65 years and older, and to people ages 12 through 64 years old with at least one underlying condition that puts them at high risk.
What qualifies as an underlying condition?

As of February 2025, the list includes things like cancer; chronic diseases of the lung, kidney, and liver; heart conditions; immunocompromised conditions; obesity; pregnancy, and others. The full list can be found here.

Does this mean I can’t get the new vaccines if I’m under 65 and don’t have an underlying condition?

Not quite, says Dr. Camins. The new FDA labels for the vaccines do mean that if you are under 65 years old, and don’t have an underlying condition that puts you at risk of severe COVID-19, getting the vaccines would be considered an “off-label” use, he notes.

This mostly has implications on getting your vaccine at a pharmacy, because some states have restrictions on pharmacists being able to prescribe vaccines off-label, and some restrict pharmacists from giving off-label vaccines even when prescribed by a doctor. Your physician and primary care provider, however, would still be able to prescribe and provide off-label vaccinations in clinics, Dr. Camins points out.

In response, New York and several states enacted actions through executive and agency orders to ensure people would still be able receive COVID-19 vaccines in pharmacies. The new federal guidance does imply that people will be able to access COVID-19 vaccines at pharmacies, regardless of label language.

What are the new recommendations for COVID-19 vaccines?

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to leave COVID-19 vaccination to an individual’s choice, rather than recommend vaccination for various populations. This deviates from the previous ACIP guidance of recommending that adults 18 and older get the vaccine, and people 6 months to 17 years old decide through discussions with a health care provider.

Several medical associations, however, have given their own guidance on COVID-19 vaccination for various demographics. These include:

  • Infectious Diseases Society of America: All people six months of age and older should receive the updated vaccine. It’s even more important for people who are 65 years and older, or have high risk for developing severe COVID-19.
  • American College of Obstetricians and Gynecologists: Recommends that patients receive an updated COVID-19 vaccine or “booster” at any point during pregnancy, when planning to become pregnant, in the postpartum period, or when lactating.
  • American Academy of Pediatrics: Recommends COVID-19 vaccination for all infants, children, and adolescents six months of age and older who do not have contraindications to receiving the vaccine.

“Medical professionals are all saying the same thing: if you’re able to receive the vaccine, you should be getting it,” says Dr. Camins. “While no vaccine is a 100 percent guarantee in preventing you from contracting COVID-19, if you do get it, data has shown that the vaccines reduce the disease severity—including avoiding the need to visit an urgent care center or emergency room—prevent hospitalization, and improve recovery, even if you’re in the high-risk category.”

Will insurance still cover COVID-19 vaccines?

COVID-19 vaccines were provided at no cost sharing previously, as it had been an ACIP-recommended immunization.

With the new ACIP recommendations, people on public insurance, such as Medicaid, or on an insurance plan that relies on ACIP recommendations to dictate coverage, should continue to receive COVID-19 shots without cost sharing, as brought up in the ACIP meeting.

“However, this is uncharted territory,” says Dr. Camins. “Do check in with your insurance provider to see if your copay would remain the same as before.”

On September 16, AHIP, a trade group representing many large health insurance companies, said in a statement that its members would offer COVID-19 vaccines with no cost sharing through the end of 2026, using the pre-September ACIP recommendations. And New York’s Department of Financial Services has issued a memo to insurance companies to remind them about relevant state laws regulating member coverage. Broadly, the letter highlights:

  • If ACIP has recommended an immunization, insurers must cover at no cost.
  • If a policy provides COVID-19 coverage, it must maintain coverage throughout the contract year, even if ACIP recommendations change in the interim.
  • For those under 19 years old, New York State requires COVID-19 vaccines to be covered at no charge, regardless of ACIP recommendations.
What’s the current COVID-19 situation like?

“As we go into the fall months, the number of cases will go up, as expected,” says Dr. Camins.

“COVID-19 is here to stay, and SARS-CoV-2 continues to evolve,” says Dr. Camins, “but as long we remain protected and have good antiviral treatments available, the situation is under control and of low concern.”

“I Am a Mount Sinai Nurse”

What is a Mount Sinai nurse? A Mount Sinai nurse is so many things: a team player, dedicated caregiver, critical thinker, continuous learner, mentor, patient advocate. And so much more.  At Mount Sinai, we believe that a Mount Sinai nurse is the nurse all other nurses aspire to be. Together and individually, they create excellence every day. Read what our patients are saying about our nurses and listen to how some of them describe what makes them a Mount Sinai nurse.

Rivkah Eisner, RN

“From the onset of labor all the way through to bringing us to the post-partum floor, Rivka worked with dedication, wisdom, and high energy to ensure a healthy and positive experience. Rivka exuded an attitude of collaboration and accommodation. She made us all feel that we were a team, and she was there to assist in every way. She was kind, focused, respectful, and full of helpful energy.” Click here to watch the video.

Will Novini, BSN, RN

My CSICU/ CVIVU (Cardiac Surgical Intensive Care Unit) center nurse Will Novini was a godsend. He got me through the two most difficult days after my surgery. I can’t say enough about how good he was.” Click here to watch the video.

Beth Lungaro, BSN, RN

“Nurse Beth Lungaro in the ER was truly outstanding. After 11 hours there, she would still show a beautiful smile, warm manners, and incredible efficiency. We could not have asked for a better nurse.”

Grace Tesoriero, NP

“I came in experiencing a great deal of pain and was angry at everyone I encountered because I just couldn’t manage it anymore. But Grace treated me as if she could feel exactly what I was going through. Her presence was calming, and just being with her made me feel better. I was truly blessed to have seen her that day.”

Uzoma Nwaekpe, RN

“One night, at 4 am I mentioned to Umoza that I was looking forward to having a conversation not about medical stuff. He stayed for 10 minutes, recited Shakespeare beautifully, and we discussed poetry. Are you kidding me? There is more intelligence, creativity, and perseverance in this group of nurses.”  

Tristen Castillo, BSN, RN and Shirley Liu, RN

“As a husband on behalf of his wife, I want to give special recognition to Tristen Castillo and Shirley Liu, whose compassionate attention and calming presence made a difficult situation much easier to bear. Nurse Castillo was thorough, kind, attentive. Nurse Liu brought a warmth and gentleness that immediately put us at ease.”

John Schwartz, RN

“John Schwartz is an outstanding professional RN. He emphasized that any unusual symptoms are important to bring to the attention of nurses.”

Of Integrity, Persistence, Leadership, and Responsibility: Mount Sinai Graduate Students Start Their Science Training

Alec C. Kimmelman, MD, PhD, keynote speaker at Mount Sinai’s Lab Coat ceremony

Alec C. Kimmelman, MD, PhD, stepped to the podium as the keynote speaker at Mount Sinai’s Lab Coat Ceremony, the celebratory start of academic research and training for the newest PhD and MD-PhD students. He recalled how he had felt a few decades earlier when he was a Mount Sinai student. “I remember sitting in the same place,” he said, “and I was wondering what the future would hold.”

For Dr. Kimmelman, who received both his MD and PhD degrees at Mount Sinai in 2003, it would be a future of extraordinary successes—starting with his own research thesis, which set the theme for his career investigating RAS-gene-driven cancers. As a student, he would also identify and characterize a novel member of the RAS family of oncogenes, and publish three first-author papers on this topic. Today, Dr Kimmelman, one of the world’s foremost authorities on the biology of pancreatic cancers, is the newly named Dean of the NYU Grossman School of Medicine and Chief Executive Officer of NYU Langone Health.

“New tools like artificial intelligence may change the scale of discovery but they don’t change its heart,” Dr. Kimmelman told the students. “At its core, science is built on people, and the way we choose to lead each other. When I was a trainee, I didn’t think of myself as a leader in any formal sense. Leadership seems like something reserved for deans or department chairs, but I soon learned that leadership often begins in the lab.” It is where building trust and “other small acts—mentoring, collaborating, encouraging—taught me that leadership is less about hierarchy and more about responsibility,” he said.

Celebrating PhD and MD-PhD students after getting their lab coats.

“Years later, when I was asked to lead a lab, and then a cancer center and, now, a health system, the principles were the same: create an environment where curiosity can thrive, where people support one another, and where integrity is never compromised. The qualities you demonstrate every day at the bench—generosity, persistence, intellectual courage—may one day prepare you for opportunities you cannot yet imagine. Leadership is not something that you wait for a title to give you. It’s something you practice, here and now, in how you approach your science and your colleagues.”

Marta Filizola, PhD, Dean of the Graduate School of Biomedical Sciences at the Icahn School of Medicine at Mount Sinai, presided over the ceremony, which was held Thursday, September 4, at Goldwurm Auditorium.

“At Mount Sinai, we continue to advance into frontiers of research that integrate cutting-edge approaches across disciplines, from artificial intelligence and data science, to stem cell biology and regenerative medicine, all aimed at improving human health and quality of life,” she said. “Our students are at the heart of this work, bringing diverse perspectives, creativity, and a relentless drive to push the boundaries of both basic and translational research.” Dr. Filizola is also the Sharon & Frederick A. Klingenstein/Nathan G. Kase, MD Professor of Pharmacological Sciences, Professor of Neuroscience, and Professor of Artificial Intelligence and Human Health.

From left: Sarah E. Millar, PhD, Dean for Academic and Scientific Affairs, Icahn School of Medicine at Mount Sinai; Eric J. Nestler, MD, PhD; Alec C. Kimmelman, MD, PhD; and Marta Filizola, PhD, lead the students in reciting the Oath for Doctoral Students.

Eric J. Nestler, MD, PhD, Interim Dean and Nash Family Professor of Neuroscience at the Icahn School of Medicine at Mount Sinai, and Executive Vice President and Chief Scientific Officer of the Mount Sinai Health System, welcomed the students and guests and spoke about the vast advances in health care made possible by science, today’s challenges to scientific inquiry, and, significantly, the need for optimism and new discoveries.

“Advances now occurring in the laboratory and clinic, driven in part by the power of computational and molecular biology and artificial intelligence, and informed by unprecedented volumes of biomedical data,” Dr. Nestler said, “will fundamentally transform the way we understand, diagnose, treat, and prevent disease. We must shout this from the mountaintops.”

However, “We live in a time when some people do question the value of scientific inquiry,” he added. “Efforts to politicize science are most unfortunate. Today, we are seeing an unprecedented assault on the nation’s scientific enterprise.”

Still, “We must remain optimistic,” he urged. “The importance of biomedical research is too strong and too widely held for us to back away, and the biomedical research enterprise is more exciting and promising today than ever before in world history.”

 

Click on the arrows below for a slideshow of faculty and students.

A New Era in Rehabilitation at Mount Sinai: Advanced Center Opens at Mount Sinai Morningside

Mount Sinai Health System has opened the newly relocated Mount Sinai Rehabilitation Center at Mount Sinai Morningside, marking a major milestone in rehabilitation medicine. The move expands inpatient rehabilitation capacity on Manhattan’s West Side—complementing Mount Sinai West—and establishes a state-of-the-art environment for patient care, research, and education.

“We’re already a magnet for patients from across the country and the world,” says Joseph Herrera, DO, Chair of Rehabilitation Medicine and Human Performance for the Mount Sinai Health System. “Now, our patients will receive care in a setting designed specifically for rehabilitation.”

Joseph Herrera, DO

State-of-the-Art Facilities

The redesigned unit is centered on patient recovery, safety, and accessibility, offering services for those recovering from spinal cord and brain injuries, stroke, and other neurological conditions.

Each large room is equipped with ceiling lifts to support mobility, while also accommodating power wheelchairs and robotic exoskeletons used in therapy.  Rooms feature digital technology that enhances accessibility, communication, and the overall patient experience.  There are several large gyms and therapy spaces, outfitted with the latest rehabilitation equipment to maximize patient recovery.

“This renovation allows us to move forward in both patient care and innovation,” says Dr. Herrera. “We now have the capacity to test and refine technologies that may become tomorrow’s standard treatments.”

A Hub for Research and Innovation

The new facility also provides expanded space for clinical research, allowing teams to pilot cutting-edge rehabilitation technologies such as robotic mobility aids, exoskeletal walking therapy, and immersive virtual reality platforms.

“These advances aim to improve recovery outcomes and restore independence for patients with complex conditions,” says Dr. Herrera.

Nationally Recognized Programs

Mount Sinai Rehabilitation Center has earned national recognition as one of only 15 National Innovation Rehabilitation Centers in the United States, under the Dr. Joanne Smith Memorial Rehabilitation Centers Act of 2023. It also serves as a nationally designated Spinal Cord Injury Model System and Traumatic Brain Injury Model System, with federal funding from the National Institute on Disability, Independent Living, and Rehabilitation Research.

The Center is accredited by the Commission on Accreditation of Rehabilitation Facilities (CARF) for seven inpatient programs in spinal cord injury, brain injury, stroke, and comprehensive inpatient rehabilitation.

“With its expanded facilities, nationally recognized expertise, and cutting-edge therapies, the new Mount Sinai Rehabilitation Center at Mount Sinai Morningside marks a new era in helping patients achieve recovery, independence, and hope,” says Dr. Herrera.

Click here to learn more

Comprehensive, Specialized Care

The center’s multidisciplinary teams include physicians, nurses, therapists, neuropsychologists, and social workers, ensuring individualized care for patients. Specialized programs include:

  • Spinal Cord Injury Rehabilitation – The only CARF-accredited program of its kind in New York City, offering robotic exoskeletons, mobility aids, and advanced therapy tools.
  • Brain Injury Rehabilitation – Integrated physical, cognitive, and psychological therapies with seamless outpatient follow-up.
  • Stroke Rehabilitation – High-intensity, interdisciplinary therapy complemented by peer support.
  • Amputation and Prosthetics Program – Pre- and post-prosthetic training, plus mentoring from peers with lived experience.
  • Exoskeletal Walking Therapy – Powered mobility support for patients with neurological conditions.
  • Neurologic Rehabilitation – Personalized care for conditions such as Parkinson’s disease, multiple sclerosis, and brain tumors.

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