Rise in Antipsychotic Drug Prescriptions For Children Raises Concerns

Off-label use of antipsychotic medications is driving a huge increase in the number of children being prescribed the medications, potentially exposing them to a number of serious side effects, including a risk of childhood diabetes, weight gain and other health problems.  

An investigation by Consumer Reports released this month details how child antipsychotic use has tripled over the last 10 to 15 years, with a disproportionate number of those prescriptions involving uses that are not approved by the FDA and target poor or minority children.

Off-label use involves prescription drugs that are given for purposes that have not been deemed safe and effective by the FDA. This can include prescribing the medication to treat conditions that have not been been fully reviewed, or use of the medications among groups of people that have not been adequately studied.

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Risperdal Lawsuits

Side effects of Risperdal linked to risk of breast growth among young boys, or gynecomastia.


While doctors are allowed to prescribe any medication off-label, and often do, it is illegal for drug companies to promote such unapproved use.

According to Consumer Reports, more and more pediatricians are prescribing antipsychotics to children for minor disorders that the drugs were not designed to treat. The pharmaceutical industry has been aggressively marketing antipsychotics on all fronts, and there is little evidence that the drugs are effective or worth the risk of some of the potential side effects, particularly for the off-label uses.

Since 2006, the number of pediatricians, instead of psychiatrists, prescribing antipsychotics is up 25%, according to the report. Those prescriptions are increasingly for things like behavioral problems and ADHD, which are not problems the drugs were originally meant to address.

Some popular antipsychotics, such as Invega and Geodon, are not approved for any childhood uses. However, those that are approved for use by children, such as Abilify, Zyprexa, Seroquel and Risperdal, are intended for the treatment of schizophrenia, bipolar disorder and autism.

The increases also come at a time when many drug companies are pushing antipsychotics to increase their profits. Some have even gone as far as to market them illegally, with Johnson & Johnson recently agreeing to pay $2.2 billion in criminal fines and civil penalties for illegally marketing Risperdal

In 2011, antipsychotic drugs brought in $18.2 billion for the pharmaceutical industry in the U.S., up from just $2.8 billion in 2003.

Questionable Safety and Benefits

According to the findings of Consumer Reports, a number of studies have found little evidence that antispychotics work to treat minor behavioral problems, yet there are a number of potential side effects of antipsychotics that could negatively affect children.

In August, a study published in the medical journal JAMA Psychiatry found that children and young teens using antipsychotics could face three times the risk of developing type 2 diabetes when compared to their peers, and the drugs have been long associated with increased weight gain. Together, that can lead to a number of serious, long-term health problems.

Another study, published in November 2011 in the medical journal Pediatrics, found that the diabetes risk was four times as high when looking solely at a class of drugs known as atypical antipsychotics, which includes Abilify, Risperdal, Seroquel and Zyprexa. That study’s findings suggested that the increased diabetes risk could be independent of diabetes risks normally associated with weight gain caused by the medications.

In recent years the side effects of Risperdal have raised concerns and resulted in a number of lawsuits over increased breast growth in boys. The condition, known as gynecomastia, can cause psychological trauma as well as physical pain and discomfort and often can only be addressed by having the breast tissue surgically removed. To make matters worse for parents dealing with the issue, insurance companies often refuse to cover the treatments, saying that the surgeries are cosmetic in nature.

Even though it has settled some of the claims against it, Johnson & Johnson still faces a number of Risperdal breast growth lawsuits from parents and young men who took the drug.

Safer Use

Consumer Reports listed a number of questions that the medical community needs to answer in the face of the increasing trend of childhood antipsychotic use.

The report calls for increased studies on whether the drugs are safe and if they actually help children. It also calls for a greater understanding of how the drugs actually work, due to possible risks of how they could affect developing child minds.

They also call for studies on what happens when the drugs are combined. According to the report, one study showed that nearly 80% of children prescribed antipsychotic drugs took one or more additional drugs, for example.

The report also laid out a number of tips for parents and medical professionals dealing with children who might be prescribed an antipsychotic.

  • Get the child a thorough check up, preferably covering physical and mental health.
  • Develop a treatment plan with established goals and other behavioral approaches before a drug is prescribed.
  • Start with the lowest dose possible and increase slowly if necessary.
  • Establish a plan for getting the child off the medication.
  • Get a second opinion if the initial health care professional tries to prescribe the drug without going through the above steps.


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