WASHINGTON — Three blockbuster psychiatric drugs currently approved for adults also appear to work in adolescents, though U.S. federal health officials have concerns about exposing younger patients to the drugs’ side effects.
The Food and Drug Administration is reviewing drugs from AstraZeneca PLC, Eli Lilly & Co. and Pfizer Inc. for use in patients between the ages of 10 and 17.
The drugs — already approved to treat schizophrenia and bipolar mania in adults — had combined sales of more than US$7.4 billion last year, according to IMS Health.
FDA reviewers on Friday said they were wary of exposing youngsters to the drugs’ side effects, including weight gain and high blood sugar, “because they may be exposed for many decades.”
“These risks are of particular concern in pediatric patients because of the lifelong nature of these disorders,” FDA director for psychiatric products, Dr. Thomas Laughren, wrote in documents posted online.
The FDA released its review of the drugs ahead of a meeting Tuesday where outside experts will weigh in on the drugs’ risks and benefits. The agency is not required to follow the group’s advice, though it usually does.