AstraZeneca seeks approval to promote use of drug in children and teenagers
By ANDREW EDER • The News Journal • November 1, 2008
AstraZeneca has asked federal regulators to let it market the antipsychotic drug Seroquel for use in children and teenagers.
The medication, and others in the class of drugs known as atypical antipsychotics, is already widely used to treat mental illnesses and behavioral disorders in children. The U.S. Food and Drug Administration had sent AstraZeneca a written request for pediatric studies of Seroquel.
The request comes as consumer groups continue to criticize the use of atypical antipsychotics in children, questioning whether the atypicals improve treatment enough to warrant their high cost.
AstraZeneca submitted a request earlier this week that Seroquel be approved for the treatment of schizophrenia in teenagers and for the treatment of acute manic episodes associated with bipolar I disorder in children and teens ages 10 to 17.
The company disclosed the news Thursday during its third-quarter earnings report
. The request was based on the results of four studies done in consultation with the FDA.
Seroquel, which is made at AstraZeneca's manufacturing facility in Newark, is the company's second-best seller, with more than $4 billion in sales last year.
Two other atypicals are FDA approved for some uses in children and teens. Doctors are free to prescribe drugs as they see fit, but drug makers may promote their medications only for FDA-approved uses.
Seroquel, a drug developed in Fairfax by an AstraZeneca corporate predecessor, has been in the middle of a controversy regarding marketing tactics and safety.
Several states and other third-party payers have sued AstraZeneca and other makers of atypicals, alleging the companies promoted their drugs illegally for so-called off-label uses, including for use in children.
According to Medco Health Solutions, a pharmacy benefit manager, the use of antipsychotics in girls ages 10 to 19 has more than doubled since 2001. In boys of the same age, antipsychotic use has risen more than 70 percent.
Taxpayers have footed much of the bill. About 80 percent of antipsychotic prescriptions in the U.S. are paid for by government programs, according to the National Institute of Mental Health. A group of state Medicaid directors is currently evaluating the use of the drugs in children on state Medicaid rolls, with plans to release a report in January.
Some researchers have raised questions about whether the atypicals improve treatment enough to warrant their high cost. A study released last month found that Zyprexa and Risperdal, two popular atypicals, caused more side effects and were less effective for children with schizophrenia than molindone, an older generic drug that costs about one-fourth as much as the atypicals.
Vera Sharav, founder and president of the human rights group Alliance for Human Research Protection, said another FDA approval for an antipsychotic would "lend legitimacy for Medicaid to be further ripped off." She said it was "criminal" for the FDA to ask for research on Seroquel in children.
"It's outrageous," Sharav said. "All the evidence points to the fact that these drugs are harming children's brains and their organs."
FDA spokeswoman Sandy Walsh said the agency's requests for pediatric information -- which have gone out to drug makers for dozens of different medications -- have expanded access to important medicines for children and promoted safety and innovation in drug development.
"Pediatric patients are subject to many of the same diseases as adults, and are, by necessity, often treated with the same drugs and biological products as adults," Walsh said. "Even with the advancements of the past 10 years, the majority of drugs still lack pediatric labeling information, and this absence of information can pose significant health risks for children."
AstraZeneca spokeswoman Abby Baron said the company has voluntarily changed its prescribing information for Seroquel to include additional safety information for children and adolescents.
Baron said Seroquel's label will be updated to note observations of increased blood pressure, changes in thyroid function tests, increases in appetite and weight, higher levels of the hormone prolactin and symptoms of movement disorders during the pediatric studies.
The label will also note that long-term safety data beyond 26 weeks on growth, maturation and behavioral development in children and adolescents are not available, Baron said.
