Risperidone, a drug the FDA approved for use in kids in 2009, has been associated with a high risk of severe side effects, according to a recent study.
The study reported in Scientific American claims that the risk of side effects due to the autism drug is much higher than initially thought.
Although physicians report that Risperidone helps with violent outbursts, the drug was never meant to be prescribed for children and drug makers may have misconstrued the risk to children.
Janssen Pharmaceuticals and other drug makers touted the autism drug as a way to manage tantrums, aggression and other behaviors associated with the condition in children.
However, the drug makers have been faced with an onslaught of litigation after Risperidone and Risperdal were found to cause severe side effects at a much higher rate than stipulated by the drug makers at the time of FDA approval.
Risperidone was originally approved for the treatment of schizophrenia in adults in 1993. Although it was only approved for limited use in children by the Food and Drug Administration in 2009, it has been prescribed to children for unapproved uses since being introduced in 2003.
The autism drug was prescribed 6.5 million times, according to reports. These reports also indicate Risperidone is being used to treat much less severe behavior than it is intended to be used for.
According to lawsuits, boys who took the autism drug are now suffering from female breast growth that is permanent and in one instance, has produced milk, leaving the affected child confused and emotionally disturbed.
Production of prolactin that leads to the breast growth is a side effect of the autism drug, according to the study. Unfortunately, surgery is the only way to reverse the effects of Risperidone. The study also revealed other harmful side effects associated with the autism drug, including diabetes, seizure, weight gain, drowsiness, hormonal changes, and involuntary movements.
Further, say researchers and physicians, Risperidone is not a “cure for autism.” In some cases, the autism drug does not work at all and it does not improve many of the core symptoms associated with autism. Risperidone is not effective in lower doses either, say physicians, exposing children to more risk for an autism drug that may not work.
Experts are becoming increasingly concerned about the risk of severe side effects in children who take the autism drug. Unfortunately, there are no alternatives to Risperidone, but, says the Scientific American report, the decision to take into account the risk of severe side effects.
“Is someone going to get hurt if we don’t intervene? And if I think the answer is yes, then I’ll be thinking about risperidone,” Jeremy Veenstra-VanderWeele, medical director of the Treatment and Research Institute for Autism Spectrum Disorders at Vanderbilt University, told Scientific American. “If I think the answer is no, I’ll be thinking about doing other things.”
If you are concerned about side effects after taking the autism drug Risperidone or Risperdal, contact the attorneys at McDonald Worley. The consultation is free.