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NGK Law Handling Risperdal Lawsuits Nationwide

Risperdal, and its current formulation, known as Invega, are anti-psychotic drugs manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Risperdal and Invega are primarily used to treat schizophrenia and bipolar disorder, but have also been used to treat irritability in people with autism. Risperdal was developed by Janssen from 1988 to 1992 as an improvement from the anti-psychotics on the market at that time. Risperdal was first approved by the FDA in 1994 for the treatment of schizophrenia, bipolar disorder, and behavior problems in people with autism. In 2004, Risperdal brought in $3.1 billion in sales, accounting for about 5 percent of Johnson & Johnson’s revenue that year. In 2007, Risperdal had over $4.5 million in sales. Today, there are many generic versions of Risperdal, which in its generic form is known as Risperidone.

Risperdal’s initial approval by the FDA was only for adults suffering from schizophrenia and bipolar disorder. There was no FDA approval for use of Risperdal in children until 2006. It is widely known that doctors can prescribe any drug, but the maker of the drug, such as Risperdal manufacturer Johnson & Johnson, can promote it only for uses approved by the FDA. Therefore, the sales representatives of Risperdal could only tell doctors to prescribe it for adults suffering from schizophrenia and bipolar disorder.

Despite not being approved for use in children until 2006, it has been argued that almost from the initial FDA approval of the drug Risperdal, Risperdal sales reps were informing doctors it could safely be prescribed for adolescents, including adolescent boys. It is argued Risperdal was consistently being prescribed “off label” for children to treat autism, irritability, aggression and other behavior disorders including ADHD. During a Risperdal lawsuit trial, there was testimony from the former commissioner of the FDA that he believed the manufacturers of Risperdal broke the law in marketing Risperdal for use in children and adolescents. He submitted a report to the Risperdal lawsuit court that “in my opinion, Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act.” When this former FDA commissioner was set to actually testify in the Risperdal lawsuit trial, the Risperdal lawsuits were settled before he could testify.

Because of Risperdal sales people promoting Risperdal for use in adolescents, doctors began to use it on children, in particular autistic males. Unfortunately, what was not relayed to the doctors is that there was mounting evidence that Risperdal could result in the growth of breasts on males, a condition known as gynecomastia. The Risperdal side effects, and the basis for Risperdal lawsuits, began to surface long before the reports on the dangerous Risperdal side effects were reported to the FDA. The problem is that the FDA is not informed of the bad effects of drugs, such as Risperdal and Invega, until they have been in use for a while and there have been a large number of “adverse events” reported.

Risperdal was not supposed to be used on adolescent males before its approval in late 2006. However, with adverse events and Risperdal side effects beginning to mount, researchers began to study the dangerous effects of Risperdal. In June 2006 researchers at Duke University found that the risk of male breast growth, or gynecomastia, was stronger with Risperdal than with the other atypical anti-psychotics on the market. The study found Risperdal accounted for 70% of the gynecomastia, or male breast growth, cases studied. In a study in the Journal of Clinical Pharmacology from 2006, it was reported that studies performed on adult patients unambiguously demonstrated a marked effect of Risperdal on prolactin blood levels with possible clinical effects related to hyperprolactinemia, such as gynecomastia and galactorrhea. J. Clin. Psychopharmacal. 2006 April; 26(2):167-171; Holzerl, Eap, CB. The study additionally found that Risperdal administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, which can therefore result in the development of male breast tissue, or gynecomastia.

Unfortunately, the FDA apparently did not heed the research regarding Risperdal male breast growth, and in August of 2007 approved Risperdal for treatment of irritability of children and adolescents with autism. This decision was based in part on a study of autistic people with severe and enduring problems of violent meltdowns, aggression and self-injury. However, Risperdal and Invega were not recommended for autistic children with mild aggression and explosive behavior without an enduring pattern. Despite the difference, approving Risperdal for use in some autistic adolescent males likely opened the door for more males to be at risk for the development of gynecomastia. Additionally, in August 2007 Risperdal was approved for ages 13-17 for schizophrenia and for ages 10-17 for bipolar disorder. It is argued that once the drug became a best seller and was prescribed widely by psychiatrists for off label use in children labeled with ADHD, that was when the real issues with Risperdal side effects began to surface.

A November 2008 report in the Wall Street Journal reported that Risperdal and Invega can stimulate the production of prolactin, a hormone involved in lactation, and can ultimately result in the growth of male breasts, or gynecomastia. This was especially found to be the case with adolescent boys. However, there is research that the growth of male breasts is not just limited to adolescent males. Recent research is indicating that adult males also have been at an increased risk for the development of male breasts as a result of taking Risperdal. The problem with Risperdal is that it stimulates the production of prolactin, which is a hormone released by the pituitary gland that stimulates breast development. Risperdal lawsuits claim that the initial Risperdal labeling downplayed the risk of adverse events resulting from the development of increased prolactin levels, and ultimately development of male breasts.

The Risperdal attorneys at NGK Law are investigating claims for males that developed Risperdal gynecomastia, or Risperdal male breast growth, after taking Risperdal. We believe that the company’s promotion of this Risperdal in a manner that was not approved by the FDA is a significant source of concern and must be remedied through a Risperdal lawsuit.