This is an antipsychotic drug that was approved by the FDA for the treatment of adults who had schizophrenia; later in 2006 and 2007 the FDA further approved more uses of this drug in the cases of children with schizophrenia, bipolar disease and also behavioral disorders that are a result of autism in children. However, there were many side effects associated with the use of Risperdal including physiological problems if this drug was used with other medications.
Risperdal is a very strong atypical or second generation antipsychotic. This drug is known as atypical because along with dopamine it also targets serotonin which maybe the reason why this is a more effective drug as compared to traditional antipsychotics.
Working of Risperdal
The liver is responsible for breaking down Risperdal into its active chemical ingredients mainly metabolites. These metabolites help to block dopamines and serotonins which in turn balance out the chemicals that are present in the brain and thus help to decrease psychotic and aggressive behavior. This drug was initially designed to work alone but can also be sometimes combined with medicines like lithium and antidepressants for individuals who suffer from bipolar disease.
FDA Approvals for Risperdal
This drug was approved in 1993 by the FDA for use in the treatment of adolescents and adults for schizophrenia. Later, this approval went on to include its use to treat adults and adolescents who suffered from bipolar disease and also children and adolescents who suffered from autism spectrum disease.
Some doctors went on to prescribe these drugs to individuals who suffered from anxiety, ADHD, depression and sleep difficulties without the approval of FDA
J&J Marketing Racket
Being manufactured by Johnson & Johnson this drug made a lot of money for the company. It was estimated that in 2007 the company had total sales of $4.5 billion. However, these sales reduced to about $358 million in 2012 when it lost out on the patent that was protecting it.
The company was still able to make $18 billion profit on this drug alone in the first two decades that this drug was in the market. J&J managed to get there by alleged illegal marketing practices that included marketing this drug to children and also paying doctors and pharmacies for nursing homes to talk favorably about this drug and use it for the treatment of the patients in the nursing homes.
Treatment of ADHD with Risperdal
Many doctors used this drug off-label for the treatment of ADHD which is a condition that causes excessive motor activity, impulsive behavior and inattention in children. This means that they prescribed the drug for this disease without the FDA approving of its use for such cases.
It was found that more than 3.5 million children who were diagnosed with ADHD were given this drug even though there was evidence of severe side effects and very little proof that this drug was actually effective for the treatment of this disease.
Some experts even stated that there was over diagnoses and misdiagnoses of ADHD in many states in the US.
FDA Black Box Warning
Other common off the label uses of this drug were for treating psychosis, agitation, aggression and other behavioral disorders that were commonly seen in patients with dementia. There were multiple serious health risks that were found to be associated with the use of this drug for elderly patients who suffered from dementia. This caused the FDA to make adding a Black Box warning to the labeling of Risperdal compulsory. This black box warning for Risperdal was issued in 2005.
Side Effects of Risperdal
Like most drugs what makes Risperdal work was what was also causing major side effects of this drug in the body that was caused due to abnormal levels of hormones in the body. These side effects were as follows
- Gynecomastia: this was one of the most severe side effects of Risperdal. This caused the enlargement of breasts in adolescent males.
- Movement disorders: another major side effect was the development of movement disorders such as Extrapyramidal Symptoms and also painful muscle movement.
- Diabetes and weight gain: The consumption of this drug was also linked to the development of high blood sugar and Type II diabetes.
- Heart Problems and Death: like most antipsychotics there is a constant risk of sudden cardiac arrest and ultimately death.