FDA weighs whether to approve drug for pediatric bipolar disorder

Federal advisers discussed whether the Food and Drug Administration should clear Merck & Co.’s drug for children and adolescents. The FDA’s regulatory path favors patients over doctors, and Merck wanted the advisory panel to endorse its drug, called vilazodone, which could be the first treatment approved for children ages 10 to 17 who experience hallucinations, delusions and disordered thinking associated with bipolar disorder.

“I see one of the hallmarks of bipolar disease is its frequently psychotic manifestations,” said Elizabeth Milton, a mental health specialist. “Some of that will be worse in younger children.”

Dr. Cynthia Tan, a psychiatrist at the University of California, San Francisco, described young people who have hallucinations in their environment, including a friend who is driving, or a police officer who whistles. “For patients who are walking by, they see a ghost,” she said.

The prescribing label recommends doctors who treat children not use for more than two weeks. After that, it says, if the child has worsening hallucinations or delusions or has a case of mania, he or she can get the drug.

“I think as adolescents, this can be pretty dangerous,” said Dr. George Heymont, a professor of pediatrics at the University of Pennsylvania and one of the advisers.

Herbert Diener, of the Tufts University Medical Center, advised against approving the drug, saying that because it affects certain neurotransmitters, it could “move the needle on depression.”

Dr. David Greenblatt, of the Boston University School of Medicine, also cautioned against the potential risks of the drug.

The panelists voted 13 to 2 that the drug should be approved for children, but the review committee did not immediately vote on the fate of the product. The FDA is scheduled to announce its decision by Nov. 4.

On the pediatric drug market, companies have to appeal to doctors and lay the groundwork for approval through clinical trials. The FDA approved Bristol-Myers Squibb’s Bipolar 2, one of the first drugs for bipolar disorder, for adults.

In an interview, Robert A. Hauser, a psychiatrist and president of the American Psychiatric Association, said the agency has often favored children. He was surprised to hear that an advisory panel had agreed that the drug should be approved for children. “We take in young people at an age when they’re exploring important aspects of their identity,” he said. “It should be an area of great study and research.”

“It’s really upsetting that the FDA would go in that direction,” said Dr. Kevin McCarthy, of the University of Wisconsin School of Medicine and Public Health.

Covidopa, made by Biogen, to treat Parkinson’s disease, may also reach the market sooner, if the advisory panel recommended its approval for treating adolescent kids. If the FDA approves it, children who have trouble walking could benefit, according to a Medco Health Solutions opinion.

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