The growth in antipsychotic-drug prescriptions for children is slowing as state Medicaid agencies heighten their scrutiny of usage and doctors grow more wary of the powerful medications.
The softening in sales for children is the first sign that litigation, reaction to improper marketing tactics, and concern about side effects may be affecting what had been a fast-growing children's drug segment.
The six so-called atypical antipsychotics that dominate the market have limited approval from the FDA to treat patients under 18 years of age. Only one is cleared for children under age 10 -- risperidone, branded by Johnson & Johnson as Risperdal -- to treat irritability associated with autism.
But doctors can prescribe drugs as they see fit, and many have turned to the atypicals to treat serious mental conditions in children, including schizophrenia and bipolar disorder. Use of Risperidone by those 18 and under accounts for about 25% of the drug's sales, while SDI Health, a medical market-research company that gathers sales information from drugstores, estimates that sales of all antipsychotics to that age group account for 15% of the drugs' sales, or $2.18 billion.
Data on use among children are hard to come by, but SDI's figures show that antipsychotic prescriptions for children under 18 rose 5.2% between 2007 and 2008, compared with an increase of 8.73% in the year-earlier period.
The slowdown is more pronounced among younger children. The nation's second largest pharmacy-benefits manager, Medco Health Solutions Inc., which handles 586 million prescriptions a year, estimates that prescriptions for antipsychotics for patients under 10 fell 4% last year. From 2001 through 2007, use in that age group increased 85%, Medco says.
SDI Health estimates that prescriptions for psychiatric drugs for children under 10 increased 3.5% last year. In contrast, between 2002 and 2007, such prescriptions rose 44.6%, it says. SDI also says it saw a 1% drop in prescriptions for those under seven last year.
"I was never a big prescriber to begin with, but I have definitely been more careful as information has come to light about the serious side effects being downplayed in the marketing of these drugs," says Michael Houston, a child psychiatrist in Chevy Chase, Md.
Others who treat children with serious and dangerous behavioral problems worry that misconceptions about the drugs will prompt some parents or doctors to balk at their use.
"For those children who are seriously mentally ill, although these side effects can be potentially significant, the benefits far outweigh the side effects," says Louis Kraus, the chief of child psychiatry at Rush University Medical Center in Chicago.
Antipsychotics have faced heightened scrutiny and investigation over the past year. In November, a Food and Drug Administration advisory committee asked the FDA to research children's use of the drugs and expressed concern about possible side effects such as weight gain and increased diabetes risk. And 11 state attorneys general are investigating alleged marketing of Eli Lilly & Co.'s antipsychotic Zyprexa for uses the FDA hasn't approved.
In January, Eli Lilly agreed to pay $1.4 billion to settle allegations it improperly marketed Zyprexa. The company also agreed to plead guilty to a criminal charge of promoting the drug for unapproved uses.
A Lilly spokesman declined to comment on ongoing litigation and said the company doesn't track the drug's use in children.
Bristol-Myers Squibb Co. agreed to pay $515 million in September 2007 to settle allegations it promoted Abilify for use in children. The FDA didn't approve of the use of the drug in children older than 10 until 2008.
State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, includingan antipsychotic, court records show.
Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.
In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.
Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.
The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.
Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.
Write to David Armstrong at email@example.comPrinted in The Wall Street Journal, page B1