A US Food and Drug Administration advisory committee will vote later today on whether three blockbuster antipsychotics should be allowed to market them to treat schizophrenia and bipolar disorder in paediatric and adolescent populations
The FDA’s Psychopharmacologic Drugs Advisory Committee will decide on whether AstraZeneca’s Seroquel (quetiapine), Pfizer’s Geodon (ziprasidone) and Eli Lilly’s Zyprexa (olanzapine), which are widely prescribed off-label, can be promoted for use in children. Two other antipsychotics, Johnson & Johnson’s Risperdal (risperidone) and Bristol-Myers Squibb/Otsuka’s Abilify (aripiprazole) are already approved for treating bipolar disease and schizophrenia in patients under 18.
Thomas Laughren, director of the FDA’s Division of Psychiatry Products, issued a memo to committee members saying that “we generally are in agreement” that the three drugmakers “have provided adequate support to suggest effectiveness” for the drugs in treating those conditions in children and adults, He added that their safety profiles appear to be “qualitatively similar to those observed with these drugs in adult patients.”
He did note that adverse reactions that can occur with these atypical antipsychotics, include sedation, weight gain, increases in blood fats and sugars and tardive dyskinesia. Winning FDA approval would be a major boost for AstraZeneca, Pfizer and Lilly and add to their already-considerable sales for the drugs.
A joint statement from groups that include Mental Health America, the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, asks the FDA to “carefully consider the importance of viable treatment options for bipolar disorder and schizophrenia in pediatric and adolescent populations. The groups say they “encourage an open and transparent scientific discourse about all pharmacologic treatments that come before the advisory committee” and urge the latter to “carefully weigh the available evidence regarding safety and efficacy”.
The letter goes on to say that in order for doctors and families to make informed decisions “they need access to a full range of medications and treatment options and to the research regarding the risks and benefits” of these drugs. The groups conclude that “more long-term clinical research in children and adolescents is also needed to better understand the risks and benefits of these medications when used over an extended period”.
