What Parents Should Know About Risperdal

Risperdal is a medication that’s widely used to treat children who are aggressive or excessively irritable. Though it was originally approved to treat psychosis, its use in children, including those with autism or ADHD diagnoses, has grown dramatically over the last two decades. That’s because Risperdal can successfully calm down kids with severe behavior problems, enabling them to function in school and within their families. Without it, some would require residential treatment.

But Risperdal (generic name risperdone) can have serious side effects, and it’s important to make sure a child taking it is monitored carefully. Parents should know what the medical community agrees are the “best practices” to be followed by a doctor who prescribes Risperdal, to insure good treatment.

Here are the basics about Risperdal: what it’s used for, potential side effects, and how a child on Risperdal should be monitored.

Risperdal is what is called an atypical, or second-generation antipsychotic (SGA). It was a new kind of antipsychotic approved by the Federal Drug Administration in the 1990s to treat the symptoms of psychosis in schizophrenia and bipolar disorder.

Now it is more widely used to treat aggression and irritability in both dementia patients, often in inpatient facilities, and in children.

Many kids on the autism spectrum take Risperdal to reduce behavior problems like aggression or self-injury, and the FDA has approved it for that use. But it’s also prescribed to many kids who have ADHD (attention-deficit hyperactivity disorder), ODD (oppositional defiant disorder) or DMDD (disruptive mood dysregulation disorder).

When kids act out dangerously or are at risk of getting kicked out of school or removed from the home, they may be given Risperdal or another SGA to calm them down. For kids who do not have an autism diagnosis, these prescriptions are off-label — that is, they are not an FDA-approved use for the drug. But a substantial body of evidence suggests they are effective in reducing persistent behavioral problems.

Risperdal is controversial because side effects that include substantial weight gain and metabolic, neurological and hormonal changes that can be harmful. Some experts are concerned that children are being treated with the drug in lieu of other treatment — including behavioral treatment — that could be effective without the risk of these side effects.

Risperdal has been in the news over the last several years because of thousands of lawsuits from families who say they were not informed about side effects that might adversely affect their kids, and the kids were not taken off the medication when problems developed. Many of the suits are on behalf of boys who, in a rare side effect, developed breasts because of an increase in a hormone called prolactin.

Wendy Nash, MD, a child and adolescent psychiatrist, describes a common scenario in which Risperdal is prescribed because a child’s aggressiveness or irritability has become acutely problematic. This behavior often presents in early adolescence, says Dr. Nash. “These are kids who are very aggressive, meaning they might push, shove, punch, break furniture.”

When these kids can’t control their tempers, they may be a danger to other children, their parents and themselves. “Sometimes their parents are so desperate they have considered calling 911,” Dr. Nash notes. Or the child might already have been sent to the emergency room after an outburst at school.

For kids in crisis, Risperdal is often clinicians’ first choice for stabilizing the situation. If it’s not a crisis, they recommend that other treatments be tried first.

Most experts, including Dr. Nash, stress the importance of thoroughly investigating the causes of aggressive behavior as part of the evaluation for medication. Behavior problems can have many different sources, including undiagnosed anxiety, ADHD, learning disorders, trauma and medical problems. Treating those problems may allieviate the behavior issues in a more effective (and lasting) way than giving the child antipsychotic medication.

For children with disruptive behavior problems that haven’t reached a crisis stage, experts’ first choice  for treatment is behavioral therapy, including parent training, to rein things in. Depending on the level of risk, Dr. Nash says she might recommend a first trial of behavioral therapy, or medication together with behavioral therapy.

In a more stable situation, Dr. Nash also favors first trying more targeted medications with fewer side effects. For instance, in a child with ADHD, stimulants (Ritalin or Aderall) or non-stimulant ADHD medications like clonidine (Catapres, Kapvay, Nexiclon) or guanfacine (Estulic, Tenex, Intuniv) could reduce impulsive aggression. For a child with ODD, she says, antidepressants (SSRIs) can help with underlying depression or anxiety that could trigger outbursts.

If these attempts are not effective, Dr. Nash may try an SGA. Abilify (aripiprazole), which is also approved for irritability in kids on the spectrum and commonly used for aggression, is usually her first choice, because it has fewer side effects, than Risperdal, including lower weight gain and endocrine disruption. But medication treatment should always be in combination with behavioral therapy, she stresses, which could include parent training.

The medical community agrees. A survey of treatment recommendations from top experts emphasizes that medication should not replace behavioral therapy.

Experts note that a child who’s been put on an SGA in a crisis might be transitioned to a different treatment after the situation is stabilized. In Dr. Nash’s experience, children who participate in behavioral therapy may later be able to stop taking the medication. “My preference is to use risperidone in a time-limited way, to settle the crisis,” she explains. “In the meantime, I’m setting up parent management training.”

Michael Milham, MD, PhD, a child and adolescent psychiatrist at the Child Mind Institute, also uses SGAs to stabilize children in crisis situations. He notes that it’s critical to not take kids off the medications without other supports in place, such as behavioral therapy, including parent training.

“It’s important to know when to try to take kids off it — and it’s not as soon as things are going well,” explains Dr. Milham. “They need to be stable, and have other interventions in place. Otherwise you’re just going to recreate the problem, and the kids end up in the ER.”

The most common side effect of Risperdal is weight gain, which can occur quickly. In one study, average weight gain after 10.8 weeks of treatment with Risperdal was 11.7 pounds, compared to just .44 pounds in children taking a placebo. In a study of children treated with Risperdal for 2.9 years, a third were either overweight or obese. Larger doses were associated with significantly greater increases in weight.

Risperdal may also cause what are called “metabolic abnormalities,” including a rise in blood sugar, lipids and trygilicerides that increase the risk of diabetes and heart disease in later life. These are more common in overweight or obese children.

Of the SGAs, the risk of metabolic side effects is greatest with Zyprexa (olanzapine), followed by Clozaril (clozapine). Seroquel (quetiapine) and Risperdal fall into the middle. On the lower end is Abilify, Geodon (ziprasidone) and Latuda (lurasidone).

Another set of possible side effects include something called “tardive dyskinesia,” which is characterized by repetitive, involuntary movements, including facial grimaces. The risk of tardive dyskinesia increases with the dose and duration of the treatment, and it can be permanent. The risk of neurological side effects is greatest with Risperdal, Zyprexa and Abilify.

The side effect that sparked the lawsuits against Johnson & Johnson, Risperdal’s maker, is an increase in a hormone called prolactin. Elevated prolactin is called hyperprolactinemia. Prolactin normally causes breast enlargement during pregnancy and milk secretion during breastfeeding. In girls, hyperprolactinemia can lead to breast enlargement, production of breast milk, and bone loss. In boys it can interfere with sperm production and cause breast growth, called gynecomastia.

Studies show that in kids taking antipsychotics, prolactin levels rise until around around 6 to 8 weeks (peaking at, in one study, four times higher than those treated with placebo), and then drop back toward normal. Higher doses of Risperdal — rather than longer use — appear to be linked to elevated prolactin levels.

But not all children who have elevated prolactin develop symptoms. Hyperprolactinemia is common (1.0 to 10 percent of patients develop it) but hormonal symptoms like gynecomastia are uncommon (0.1 to 1.0 percent).

Of the second-generation antipsychotics, Risperdal shows the greatest increase in prolactin levels, and Abilify the least.

Children taking Risperdal or another atypical antipsychotic should be monitored by their doctors regularly over the course of treatment. Before treatment begins, they should be tested to establish baselines for height, weight, vital signs, and levels of prolactin and blood fats and sugar.

Prolactin levels should be measured frequently during the first few months of treatment. If the child has elevated prolactin and shows symptoms of hyperprolactinemia, it’s recommended that the dose be tapered off and the child be switched to another SGA. If a child has elevated prolactin but shows no symptoms, it’s recommended that he continue to be monitored on a yearly basis if he is using the medication long-term, as prolonged effects of elevated prolactin on fertility and bone development are not known.

A group of Canadian researchers note that yearly lab tests with a physical exam for stable patients may seem like a waste of time to busy clinicians. But given the potential consequences, they add, “Clinicians who are unprepared to monitor children for side effects should choose not to prescribe these medications.”

As with any medication, it is important to talk to your doctor about any concerns you have. Your child’s clinician should be ready to discuss the symptoms you are seeing and explain potential options for changing dosage or medication. If you don’t feel that your child’s doctor is taking your concerns seriously, or your doctor is not following best practices for changing dosage, or adding new medications, you should get a second opinion.

If you believe your child should stop taking Risperdal, make sure you tell your doctor, and discuss the pros and cons. Don’t make adjustments or withdraw the medication without consultation. Antipsychotic medications should be reduced gradually, and the child should be monitored for side effects of withdrawing too quickly, including runny nose, diarrhea and cramping. And remember: The biggest concern to watch for is the return of dangerous behavior that the medication was prescribed to treat in the first place.