WASHINGTON, June 11 (AScribe Newswire) -- Martha Hellander, executive director of the Child & Adolescent Bipolar Foundation (CABF), called upon the Food and Drug Administration (FDA) to do post-marketing studies of lithium use in children and adolescents as well as to conduct juvenile animal studies with the off-patent drug that is a mainstay of treatment for bipolar disorder, also known as manic-depressive illness.
Testifying before the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee of the FDA, Ms. Hellander said that due to recent advances, children can now be diagnosed with bipolar disorder before puberty, but no medications are approved for mania in this age group, and no long-term follow up studies or testing in juvenile animals have ever been done.
"We've got a public health crisis in the making. With recent advances in diagnoses doctors can detect the illness in children before they reach puberty. There are many new treatments in development that hold great promise for children, but lithium is being overlooked because it is off-patent and pharmaceutical companies don't wish to invest further in this drug."
"Lithium meets all the requirements of the Best Pharmaceuticals for Children Act and the urgent public health crises of teen substance abuse, incarceration, and suicide, all of which include many children which we now know have bipolar disorder, call for lithium testing to be given the highest priority by the FDA."
Children with bipolar disorder are biologically vulnerable to developing a substance abuse disorder. Lithium significantly reduces substance use and stabilizes mood in teens with dual diagnosis. Children with bipolar disorder are impulsive, can exercise bad judgment, and may end up in the juvenile justice system when ill. If the illness is detected early enough and properly treated, these outcomes can be avoided. Nearly 25 percent of children with bipolar disorder are suicidal. Lithium is known to reduce suicide as much as eightfold even when ineffective in treating mood.
Lithium has been used in adults in the United States for over 50 years. It is a relatively safe drug in adults. The indication for children over 12, when approved in 1970, was not based on any studies in adolescents. No post marketing surveillance has been done to collect follow-up data and there is no long-term safety and outcome data.
Hellander said, children metabolize drugs differently than adults, and are not miniature adults. These drugs may affect the developing bodies and brains of children - both negatively and positively - differently than in adults. Standard practice in testing drugs in children is now to first test in juvenile animals to detect age related problems.
"Children with bipolar disorder should not be ignored just because they are a smaller market than adults. The data is not there. A systematic, expanded reporting system is needed for lithium, and ideally all drugs used in children," according to Hellander.
Hellander presented results of an online poll of CABF Web site users. Of 854 respondents with children under 19, over half have been hospitalized; thirty percent were on lithium and an average of three meds. The majority were also on prescribed antipsychotics (68 percent) and anticonvulsants (79 percent) from a sample of nearly 40 drugs used to treat symptoms of bipolar disorder and related conditions.
Bipolar disorder in children is under-diagnosed and can be mistaken for ADHD because both have symptoms of irritability, poor concentration and distractibility. Only bipolar disorder has symptoms that include elated mood, grandiosity, flight of ideas, decreased need for sleep, suicidal behaviors, hypersexuality, and rapid shifts from euphoria to marked sadness, says Hellander. Children with pediatric bipolar disorder may also have significant learning disorders and other conditions such as anxiety.
CABF is the only national, not-for-profit organization devoted solely to education, support and advocacy for families raising children with bipolar disorder. CABF's Web site, www.bpkids.org, receives more than 2,000 visits daily. The interactive Web site offers an extensive library, message boards, chat rooms, a database of doctors free online support groups, a gallery of children's art, and more.
Martha Hellander has consulted on the design of treatment studies for adolescent bipolar disorder and has acted as the bioethics consultant to a multi-site National Institutes of Mental Health (NIMH) funded treatment study. She has also participated in strategic planning for mood disorders research at the NIMH, and served on a recent NIMH grant review committee for studies in child psychiatry. Hellander is also a member of the Pediatric Psychopharmacology Initiative workgroup of the American Academy of Child and Adolescent Psychiatry.
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