FDA Flags Weight Loss Risk In ADHD Meds For Kids — J&J, Novartis Escape New Warning

U.S health officials are updating the prescribing labels of long-acting ADHD medications to carry new warnings for children under the age of six.

The Food and Drug Administration (FDA) said Monday that all extended-release stimulants used in the treatment of attention-deficit hyperactivity disorder (ADHD) would carry a "limitation of use" caution in their prescribing information, according to a Reuters report. 

The update comes after clinical data found that young children were more likely to absorb the medication and suffer from side effects compared to their older counterparts.

While the drugs are not approved for use in kids younger than six years, the FDA said that they may be prescribed off-label to patients in that age group. 

The agency stated that the risks associated with these medications "may outweigh" the benefits for children under six years old.

The warning will cover a wide range of stimulant-based drugs, including those containing amphetamine and methylphenidate. 

Johnson & Johnson said that the new FDA criteria do not apply to its ADHD drug Concerta. Novartis, which makes another popular ADHD drug, Ritalin, has also said it would not be affected by the changes.

ADHD is one of the most commonly diagnosed behavioral disorders, with millions of children in the U.S affected by it. 

It’s estimated that 7 million children between the ages of three and 17 have the condition. 

The most common treatment is stimulant medication. 

Stimulants help children stay focused and control impulsiveness by increasing levels of certain brain neurotransmitters, such as dopamine and norepinephrine.

The American Psychiatric Association issued an official statement following the publication of the updated safety alert. 

The statement confirmed that medications serve as effective treatments for many children, but recommended that parents discuss both the risks and benefits with their child's physician.

On Stocktwits, retail sentiment for Johnson & Johnson and Novartis was ‘bearish’ amid ‘high’ message volume.

While Johnson & Johnson’s stock has risen 6.1% so far this year, shares of Novartis jumped 24.6%.

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