Managing autism in children can be a delicate task. Only a few medications are FDA-approved to treat children’s behavioral symptoms associated with autism.

Some like Risperdal come with a risk of side effects that are worth being informed about.

Risperdal is one of the few drugs approved by the FDA to treat symptoms of autism in children. Also known by the generic name risperidone, Risperdal first entered the market in 1993. It’s one of a class of psychiatric drugs known as atypical antipsychotics.

At that time the FDA had approved Risperdal only as a treatment for schizophrenia, and only in adults. Today Risperdal is also approved as a treatment for behavior problems associated with autism in children and teenagers from 5 to 16 years old.

Weight gain and increase in appetite are well documented Risperdal side effects. Families of children taking Risperdal may need to impose certain controls on diet and exercise to mitigate the weight gain that can come with taking Risperdal.

The extra weight itself puts the child at an increased risk for developing cholesterol problems and type 2 diabetes.

Another Risperdal side effect is elevation of the hormone prolactin. Prolactin has a hand in the development of bones, and in healthy women it stimulates breast tissue development and milk production.

Part of Risperdal’s mechanism of action blocks the action of dopamine, a naturally-occurring neurotransmitter in the brain. Reduced dopamine activity can lead to increased levels of prolactin.

An increase in prolactin has been measured in a large proportion of Risperdal users – as much as 90 percent of subjects in one study published in the Journal of Clinical Psychiatry.

Increased prolactin can be particularly problematic when it triggers the development of breast tissue in males. This condition is known clinically as gynecomastia. It’s one of the more notorious Risperdal side effects in children, since it has been the subject of a number of recent Risperdal lawsuits.

Some patients have reported developing extraordinarily large breasts while they were taking Risperdal. The weight gain that can also happen on Risperdal can aggravate the gynecomastia.

But while patients may be able to shed the excess pounds after discontinuing Risperdal, some report that their gynecomastia remained and failed to resolve on its own. In stubborn cases like these, surgery may be necessary to remove the excess breast tissue.

Litigation Over Risperdal Side Effects

In 2013, Risperdal’s manufacturer Janssen Pharmaceuticals was taken to task for disregarding the dangers of Risperdal side effects in some of its marketing.

Federal regulators alleged that in 2002 and 2003 Janssen had improperly marketed Risperdal as a treatment for autism in children, years before the FDA approved it for use in younger patients.

The allegations were part of a broader investigation that culminated in Janssen’s agreement to pay $2.2 billion in penalties.

In a civil lawsuit over Risperdal side effects in children, documents uncovered included two data tables that had been missing from the published version of a 2003 study commissioned by Janssen to study the effects of long-term Risperdal use.

The published study showed a conclusion that the increased levels of prolactin had no correlation with gynecomastia or other potentially related Risperdal side effects.

Yet once the missing tables were revealed, their data did indeed show a statistical correlation between elevated prolactin levels and certain Risperdal side effects, directly contradicting the published study’s conclusion.