Amphetamine

Bengaluru: 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)

Through Pediatric Research Equity Act (PREA) postmarketing requirements (PMR), FDA required drug sponsors to evaluate pharmacokinetics (PK), efficacy, and safety of extended-release stimulants in children 4 to 5 years of age. Although the Agency determined that extended-release stimulants are generally safe and effective for older age groups, product labeling for 4 extended-release stimulants include a Limitation of Use statement describing that younger children experienced higher exposures at the same dose relative to older pediatric age groups and higher rates of adverse reactions, including weight loss. To understand the application of the existing Limitation of Use to all extended-release formulations of amphetamine and methylphenidate, the Agency evaluated differences in PK profiles and exposure-response relationships across pediatric age groups and assessed the short- and long-term effects on weight in children 4 to younger than 6 years of age. Following an assessment of the available clinical trial data in these children, the Agency identified the following: Drug exposures were generally higher relative to older children at the same dose Higher drug exposures were linked to a greater risk of adverse reactions Clinically significant weight loss (at least 10% decrease in the Centers for Disease Control and Prevention (CDC) weight percentile 1 ) was observed in both short- and long-term studies with extended-release stimulants Findings are consistent for both amphetamine and methylphenidate-containing products Because the safety profiles for amphetamine and methylphenidate are generally similar and their pharmacodynamic effects are strongly linked to their PK profiles, it is reasonable to expect that that the results of this assessment apply to all formulations of extended-release amphetamine and methylphenidate, and that there is an unfavorable benefit-risk profile for children younger than 6 years taking these medications for ADHD. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.