By Sneha S K (Reuters) -The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to treat attention-deficit hyperactivity disorder to include warnings about the risk of weight loss and other side effects in patients under six years old. The FDA said that it is requiring […]
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US FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6
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By Sneha S K
(Reuters) -The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to treat attention-deficit hyperactivity disorder to include warnings about the risk of weight loss and other side effects in patients under six years old.
The FDA said that it is requiring a “limitation of use” section in the prescribing information of all extended-release stimulants to include a statement on higher rates of adverse reactions in children younger than six years.
ADHD is a disorder, common among children, that affects the ability to pay attention, follow directions and complete tasks.
The FDA has approved two types of medications — stimulants and non-stimulants — to help reduce ADHD symptoms.
Stimulants, sold under brand names Ritalin by Novartis and Concerta by Johnson & Johnson’s unit Janssen, are commonly prescribed by healthcare professionals. These stimulants function by increasing levels of dopamine and norepinephrine in the brain, two neurotransmitters linked to motivation, attention and impulse control.
This new FDA requirement is not applicable to Concerta, a J&J spokesperson said.
Extended-release stimulants are not approved for children younger than six years, but healthcare professionals can prescribe them “off label” to treat ADHD, the FDA said.
The agency said it assessed data from clinical trials of extended-release formulations of amphetamine and methylphenidate for ADHD treatment, finding that, compared to older children, patients younger than six years have higher levels of the drug in their bodies as well as higher rates of side effects.
For these reasons, the benefits of extended-release stimulants may not outweigh the risks in patients younger than six years, the FDA said in a statement.
“Stimulants are a proven treatment for children and adolescents with ADHD … As with any medications, parents need to weigh the risks and benefits for their child,” the American Psychiatric Association said in a statement.
An estimated seven million children in the United States, aged between three and 17 years, have been diagnosed with ADHD, according to the FDA.
(Reporting by Sneha S K and Puyaan Singh in Bengaluru; Editing by Alan Barona and Mohammed Safi Shamsi)