Doctors today are more aware of the potential for serious side effects when young children take powerful psychotropic drugs. Doctors and consumers have also become more suspicious of the companies selling psychotropics, as several have been accused of improperly marketing these profitable drugs. Prescriptions of the drugs to young children are still on the rise, but the rates are rising much more slowly than they were just a few years ago.Between 2002 and 2007, prescriptions of all psychotropic drugs to children under ten increased 44.6%. Last year, prescription rates increased only 3.5%. The rate for prescriptions to children under age seven actually decreased, by an estimated 1%.
Antipsychotics, one class of psychotropic drugs, have especially come under suspicion in recent years. There are six main atypical antipsychotics on the market, and only one was approved for children under age ten before this year. Doctors are free to prescribe such drugs to unapproved age groups in a practice known as "off-label" use. Between 2002 and 2007, prescriptions of antipsychotics to children under ten rose 85%. But in 2008, that rate fell 4%.
The drop in prescriptions of antipsychotics to children results partly from reports of serious and even fatal side effects. Rebecca Riley, a Massachusetts girl who was diagnosed with bipolar disorder at the age of three, died of an overdose of psychiatric drugs in 2006. Many Americans were shocked to learn that toddlers were being diagnosed with bipolar disorder and taking cocktails of multiple psychiatric drugs.
Additional stories of side effects and deaths spurred a number of states to action, and in 2007 a group of 16 states initiated an investigation of the pediatric use of psychotropics, under the slogan "too many, too much, too young." Washington, California, and Florida have taken steps to regulate or flag prescriptions of the drugs to children who are on Medicaid.
"I was never a big prescriber to begin with," Maryland child psychiatrist Michael Houston told the Wall Street Journal, "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." Bristol-Myers Squibb and Eli Lilly, creators of the antipsychotics Abilify and Zyprexa, have paid large settlements over allegations they marketed the drugs inappropriately for "off-label" use in young children. Bristol-Myers Squibb paid out a $515 million settlement in 2007. Eli Lilly paid $1.4 billion and pleaded guilty to the charge of illegally promoting the unapproved use of Zyprexa.
American children are by far the most medicated with psychiatric drugs in the world. (See article, page 2.) The trend toward greater caution with antipsychotic and other psychotropic drugs for children may continue to grow, but if so, it will be in spite of the Food and Drug Administration (FDA). In June, an FDA advisory committee told the FDA to approve three more antipsychotics, including Zyprexa, for pediatric use. If the FDA accepts the recommendation, as it is expected to do, prescriptions of these drugs to children will no longer be "off-label," and drug companies will legally market the products for use in young children. The three drugs already draw in more than $10 billion a year for Eli Lilly, AstraZeneca, and Pfizer.
Critics of this new recommendation claim that the advisory committee examined studies that followed too few patients. Some of the studies tracked patients for just three to six weeks, but children who are prescribed antipsychotics could take the drugs for years or even decades. (Reuters, 6-9-09)