Risperdal is a product of Johnson & Johnson, the world’s largest drug and biotech company. Used to treat certain mental and mood disorders (including schizophrenia and bipolar disorder, it’s touted as a drug that can “help you to think clearly and take part in everyday life.” A member of the atypical antipsychotics drug class, it is injected into a muscle (upper arm or buttocks) typically once every two weeks. There are known benefits from using this antipsychotic for the correct age demographic. However, evidence shows Johnson & Johnson illegally marketed the drug as a safe treatment for autistic children prescribed Risperdal. It’s also been used to treat other mental and behavioral disorders in children long before the FDA approved Risperdal for those uses in 2006.
The drug’s widespread misuse means thousands of children prescribed Risperdal were treated for conditions that weren’t yet FDA-approved. As a result, many have suffered long- and short-term side effects — some of which are irreversible.
Short-Term Side Effect Risks for Children Prescribed Risperdal
A 1993 safety review tested treatment of children suffering from behavioral disorders and psychosis with Risperdal. This review found the earliest Risperdal trials showed significant side effect rates. Some short-term risks include:
- Involuntary twitches
- Somnolence
- Diabetes
- Significant weight gain (most frequent)
- Headaches
- Vomiting
- Bloating
- Nausea
- Other stomach ailments
Studies conducted since 1993 confirmed these side effects. Since each patients responds to Risperdal in a unique way, it’s difficult to track all potential side effects. Even more worrisome is the fact that symptoms often return when the drug is discontinued. In 2006, the FDA approved Risperdal as the first drug to treat irritability in autism patients. Since then it has come to be known as an “autism drug,” even though professionals agree that it doesn’t improve many of the core behaviors presented with autism.
Risperdal “is not a cure for autism. It doesn’t really go to the core symptoms of autism,” said Benedetto Vitiello of the Child and Adolescent Treatment and Preventative Intervention Research Branch at the National Institute of Mental Health. More recent side effects include increased appetite (resulting in the extreme weight gain). Children prescribed Risperdal typically gain six pounds within eight weeks. Drowsiness and hormonal changes are also possibilities.
Professor of Pediatrics at the Marcus Autism Center at Emory University Lawrence Scahill says that while the drug does reduce tantrums and self-injury, its use isn’t sustainable. Scahill adds that if he prescribed Risperdal for an autistic child, “I would use as low a dosage as I possibly could and I would periodically see if I could take him off.” While Risperdal’s short-term side effects can cause extreme discomfort in children, they pale in comparison to the drug’s long-term complications.
Long-Term Complication Risks for Children Prescribed Risperdal
Austin Pledger, an autistic Alabama man starting taking Risperdal in 2002 at age eight. At the time, his mother was unaware of the drug’s associated long-term risks. Further, it was not FDA-approved for children and adolescent use until late 2006. Risperdal was marketed off-label to Pledger’s pediatric neurologist.
As a result of taking the Risperdal, Pledger had grown size 46DD breasts by age 20. Pledger’s physician, Dr. Jan Mathisen, testified that he was unaware that gynecomastia (male breasts) were even a possibility. “If he had been,” he said, “he would have discussed it with the family.”
Austin Pledger isn’t the first adolescent diagnosed with Risperdal gynecomastia. Others are filing claims against Johnson & Johnson for failing to warn the public about drug risks in children prescribed Risperdal for off-label use. The drug’s label does not mention gynecomastia and other possible short-term side effects on Risperdal’s label or packaging.
The FDA’s Involvement with Risperdal
In 1993, the FDA approved Risperdal for adults with schizophrenia and bipolar disorder. By 1996, sales of Risperdal were upward of $589 million. That’s when Johnson & Johnson sought FDA approval for Risperdal use in children.
The FDA shot down their initial attempt: “Your supplement (to the approved label) proposes the expansion of Risperdal use into pediatric patients, however, you never state for what child or adolescent disorders Risperdal would be intended… Your rationale for proposing this supplement, appears to be simply that, since Risperdal is being used in pediatric patients, this use should be acknowledged in some way in labeling.” The last sentence suggests Johnson & Johnson had already begun expanding their label limits and promoting Risperdal as a treatment for children before the FDA approved it, and the numbers confirm it.
By 1999, the pediatric market drove more than 20% of Risperdal sales in the United States (totaling $892 million).
In November 2000, research scientists from Johnson & Johnson completed a study showing Risperdal’s long-term effects among children and adolescents. They found that 319 children, including 266 males, developed gynecomastia (male breasts). This included 5.5% of male children prescribed Risperdal, which is statistically significant.
Despite these numbers, the FDA approved Risperdal in 2006 to treat autistic behavioral disorders in children. And in 2007, the FDA approved Risperdal to treat bipolar disorders and schizophrenia. The FDA says Risperdal’s side effects may include drowsiness, fatigue, appetite increase, nausea, dizziness, dry mouth, tremor, and rash. However, gynecomastia and the devastating consequences of Risperdal’s long-term use aren’t mentioned anywhere.
Justice is Served
Despite warnings and studies demonstrating Risperdal’s harmful effects, Johnson & Johnson didn’t add a clear warning to the drug’s label. Nor did they inform pediatric physicians about short-term and long-term risks for children prescribed Risperdal. As a result, thousands of boys developed gynecomastia and suffered devastating psychological and emotional trauma.
Austin Pledger filed the first Risperdal lawsuit, but he won’t be the last. Others are suing the drug giant for failing to warn consumers about risks and marketing it illegally for off-label use in children before FDA approval.
If you or a loved one took Risperdal and suffered gynecomastia or other debilitating side effects, you may be eligible for compensation. To see if you may have a claim, get a free Risperdal case review today.
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.