FDA Warns of Weight Loss Risk in Children Under 6 Taking Extended-Release ADHD Medications

KBD Attorneys Monitors Drug Safety Updates That Affect Children and Families

Source: FDA Drug Safety Communication – July 2025

At KBD Attorneys, we believe protecting children from harm—including harm caused by dangerous or improperly prescribed medications—is one of the most important ways to fight for justice. That’s why we closely monitor updates from the U.S. Food and Drug Administration (FDA) regarding drug safety. On July 15, 2025, the FDA issued a Drug Safety Communication requiring expanded warning labels on all extended-release stimulants used to treat ADHD, highlighting serious risks of weight loss and other side effects in children under six.

This safety alert addresses a concerning issue: off-label prescribing of extended-release amphetamines and methylphenidates to children younger than 6 years old. These medications are not approved for that age group—but they are still prescribed, and now we know they may pose a greater risk of harm than previously recognized.

Let’s explore what this warning means for families, how it fits into the broader picture of ADHD treatment, and how KBD Attorneys supports families whose children have been harmed by negligent pharmaceutical practices or dangerous drugs.

What Did the FDA Announce?

In its July 2025 statement, the FDA required manufacturers of extended-release ADHD stimulants to revise drug labeling to include the following:

• A Limitation of Use section specifically warning that:
  • These drugs are not approved for children under age 6
  • Higher plasma exposures and higher rates of adverse reactions, including weight loss, have been documented in that population 
• Clear, consistent warnings across all drugs in the extended-release stimulant class, even those that already contain some limitations 

The affected drugs include long-acting formulations of:

• Amphetamines (such as Adderall XR, Mydayis)
• Methylphenidates (such as Concerta, Ritalin LA, Daytrana) 

While health care providers have the legal authority to prescribe medications “off-label” when deemed medically appropriate, the FDA is reminding prescribers that these extended-release stimulants are not suitable for young children due to higher toxicity risks and unpredictable side effects.

Background on ADHD and Treatment Challenges

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders among children. It affects a child’s ability to pay attention, regulate impulses, and control hyperactive behaviors. First-line treatment typically includes:

• Medication, such as stimulants
• Behavioral therapy
• Lifestyle modifications (nutrition, sleep, environmental strategies)

For children under 6 years old, immediate-release stimulants and behavioral therapies are more commonly recommended. However, for a variety of reasons—including convenience, parental pressure, or prescriber preference—some children are placed on extended-release versions too early.

The FDA’s update underscores that these extended-release versions carry a greater risk of adverse reactions in younger children, including:

• Significant weight loss
• Loss of appetite
• Developmental delays
• Irritability, insomnia, or anxiety
• Cardiovascular stress in some cases

What Should Parents and Guardians Know?

If your child is under 6 years old and is currently taking an extended-release ADHD medication, the FDA recommends:

• Contacting your pediatrician to reassess the medication
• Watching closely for weight loss or behavioral changes
• Discussing alternative treatment options, including (Immediate-release stimulants (which are FDA-approved for younger children)Non-pharmacological therapies, like behavioral counseling)

It’s important not to stop the medication abruptly—work with a licensed medical provider to create a safe tapering or transition plan, if needed.

What Should Doctors Do?

Health care providers should:

• Avoid prescribing extended-release stimulants to children under 6 unless absolutely necessary
• Educate parents about heightened risks
• Closely monitor children’s growth and development
• Consider switching to safer alternatives or referring to ADHD specialists
• Track and report any adverse events through FDA’s MedWatch program

These updated guidelines aim to standardize safety messaging across the entire drug class and prevent children from suffering preventable harm.

KBD Attorneys and ADHD Drug Litigation

At KBD Attorneys, we handle cases where children or adults have been harmed by unsafe medications, including drugs prescribed:

• Off-label without proper warning
• Without full informed consent
• In ways that contradict FDA guidance

We’re closely watching the consequences of long-term stimulant use in children, especially those who suffer unforeseen side effects like permanent weight loss, growth stunting, or neurological issues.

Our legal team includes lawyers licensed in Maryland, Massachusetts, Pennsylvania, D.C., Florida and North Carolina, and we collaborate with medical experts, toxicologists, and child psychologists to investigate potential pharmaceutical harm.

If your child experienced:

• Unexplained weight loss
• Hospitalization for stimulant side effects
• Long-term developmental harm

— after being placed on ADHD medication before the age of 6, you may have a legal claim. We can help you explore your options.

Tied to a Broader Mission

This blog is part of our broader effort to protect consumers and families from dangerous medical products/medications and preventable corporate negligence. KBD Attorneys maintains a number of educational pages and ongoing blog series on topics including:

• Pharmaceutical liability
• Children’s medication risks
• ADHD drug safety
• Pediatric malpractice

We’ve also written about:

• Tepezza and its link to hearing loss
• The dangers of mail-order ketamine therapy
• Singulair Linked to Mental Health Risks (Singulair suicidal)
   

These issues all intersect with one principle: patients deserve safe treatment options—and families deserve the truth when companies fall short.

Parents Deserve Clarity, Children Deserve Protection

The FDA’s expanded labeling requirements are an important step, but they come years after extended-release stimulants became popular. Many parents may have unknowingly exposed their young children to risks that weren’t properly disclosed.

We believe pharmaceutical companies should be held accountable when:

• They fail to properly warn the public
• Their marketing encourages off-label use
• Children suffer lasting damage from medications pushed too early\

If your child has experienced significant harm from ADHD treatment, we’re here to listen and help. You may be entitled to financial compensation for medical costs, emotional distress, and the lifelong impact of preventable injury.

Contact KBD Attorneys

We offer free, confidential consultations for families whose children may have been harmed by dangerous or improperly prescribed ADHD medications.

Let us help you understand:

• Whether you have a case
• What documentation is needed
• What compensation may be available

You are not alone in this.

Contact us today to speak with our legal team, or visit our Drug Injury Resources to stay informed about evolving risks and safety alerts.

Remember: No parent expects their child’s treatment plan to result in long-term harm. At KBD Attorneys, we’re fighting to make sure medical decisions are made safely—and that families have a voice when they aren’t.

Let us help you protect your rights and your child’s future.