History of Risperdal

Posted by on Mar 14, 2014 in Medical Defects | 0 comments

Risperdal is the trade name for the atypical (2nd generation) antipsychotic drug risperidone, developed, manufactured and marketed by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson (J&J). Antipsychotic drugs have been used as treatment for maladaptive behaviors since the 1950s, when first generation (typical) antipsychotic drugs were first prescribed to children and young adults. Typical antipsychotic drugs include haloperidol and clozapine.

The first generation of antipsychotics, however, were associated with a range of side effects from mild to life threatening, and patients who were taking them formed chemical dependences on the drugs. To counteract these side effects, the 2nd generation antipsychotics were developed and introduce in the 1980s, and are considered a significant improvement on typical antipsychotics in terms of efficacy and extrapyramidal symptoms (movement disorders). However, atypical antipsychotics are not without side effects.

Risperdal was first approved by the Food and Drug Administration (FDA) for the limited time treatment of adults with schizophrenia in 1993. Ten years later, it was also approved for use on adults with bipolar I disorder category (manic depression). Autistic children and teenagers were next in line when Risperdal was approved for their treatment in 2006, and in 2007 it was certified as the go-to drug for children between the ages of 13 and 17 who exhibited symptoms of schizophrenia as well as viable treatment for children between 10 and 17 who exhibited symptoms of bipolar disorder.

The fact that the FDA approved the use of Risperdal as a treatment to pubescent and adolescent patients is remarkable because it was the first time an antipsychotic drugs was deemed safe enough for this population. J&J marketed the drug for all it was worth, eventually making it the most popular antipsychotic in the market. Many parents struggling to cope with the problems associated with dealing with children with psychiatric problems, including conditions such as attention deficit hyperactivity disorder (ADHD) which is not approved by the FDA, hoped that Risperdal would be the final solution. By 2013, J&J was agreeing to a $2.2 Billion settlement for the improper promotion of the drug for unapproved conditions.

The generic version of Risperdal became available in the last quarter of 2008. Risperidone¬† was manufactured and sold by Dr. Reddy’s Laboratories, Inc., Teva Pharmaceuticals, and Patriot Pharmaceutics.

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