Janssen Pharmaceuticals, Inc., a Johnson & Johnson company was charged with concealing the adverse effects of risperidone, a popular antipsychotic drug.
Risperidone is one of the major drugs that block dopamine D2 receptor in the brain. Excessive releasing of endogenic dopamine can cause hallucination, delusion, and pathological excitement. It has been deemed as a primary pathological action in the brain of the patients with schizophrenia. Therefore, risperidone is considered to be a strong solution for schizophrenic patients.
In addition, risperidone has been approved for a medical indication for other diseases, such as bipolar disorder and autism spectral disorders, in the US.
However, blocking of dopamine function cause some side effects. For example, muscle rigidity and tremor emerge due to exhaustion of dopamine in the nigrostriatal pathway.
Also, risperidone can enhance the release of prolactin, a hormone related to milk generation. Some people taking risperidone, or some other antipsychotics, will suffer from enlarged breast and undesired milk release.
It is well known that risperidone can elevate the prolactin level. To avoid this adverse effect, we sometimes measure the prolactin level of the patients taking risperidone. The issue is, however, the data regarding this side effect in children had been concealed from clinicians.
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Risperidone was approved to be prescribed to autistic children who have uncontrollable impulsiveness by the Food and Drug Administration in the US in 2006. However, the document about drug information published at the approval for children with autism lacked the warning about the continuous elevation of the prolactin level, although it had already been suggested in a clinical trial.
Through some cases in which serious adverse effects were observed, the suspicion that Janssen deliberately concealed the side effect was indicated. Johnson & Johnson, the parent company of Janssen pleaded guilty, and had to pay more than 2 billion USD in penalties and settlements. Furthermore, several lawsuits are expected to break out all over the world.
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Johnson & Johnson was also accused of illegal promotion to be forced to pay 2200 million USD in 2013. It was one of the biggest amounts of penalty for a pharmaceutical company.
If this case is a fraud Janssen intentionally conducted, I can never forgive Janssen. On the other hand, an elevated level of prolactin is an adverse effect easily predictable in children as well as adults. Even if the drug information lacks the description of this risk, the clinician should be cautious in prescribing risperidone to children. I am doubtful the medical practitioners who continued to prescribe risperidone to the children who were suffering from their breast growing are entirely innocent.