Thursday, July 18, 2013

Drug Makers Face Legal Challenges Over Risperdal Adverse Effects

Ten years ago, a psychiatric medication known by the trade name Risperdal had been introduced to the pharmaceutical market by Ortho-McNeill-Janssen Pharmaceuticals Inc. and its parent company, Johnson & Johnson (J&J).  Not long after its market release, the drug has been hailed as one of the bestselling antipsychotic medications in the United States, filling about 12 million prescriptions each year, according to online news reports.  As it grew in popularity, however, several studies, mounting adverse-event reports, and a handful of Risperdal lawsuits have started to emerge, highlighting serious safety problems that have been associated with the use of the powerful antipsychotic drug.

Risperdal: A Brief Overview

Risperdal, otherwise traded by its generic equivalent risperidone, is a second-generation antipsychotic drug classified among different medications as atypical antipsychotics.  The US Food and Drug Administration primarily approved the drug for schizophrenia in adults in 1993, extending its approved uses to include bipolar I disorder in adults in 2003.  After three years, the federal agency once again broadened its indications by adding irritability symptoms in children with autism, and pediatric bipolar I disorder and schizophrenia a year after. Although Risperdal has been highly regarded because of its therapeutic effects against a variety of psychiatric conditions, it has also been reported to cause unanticipated adverse effects, forcing many patients and their loved ones into action by challenging Janssen Pharmaceuticals and J&J with a lawsuit.

Alleged Risperdal-Related Gynecomastia Leads to Hundreds of Lawsuits

In July 2010, a gynecomastia-related lawsuit was filed in a Pennsylvania court against Janssen Pharmaceuticals.  Gynecomastia is one of the most prominent adverse effects that have been reported to emerge from the use of Risperdal.  It is a condition marked by the abnormal growth of breasts in males.  The 21-year-old plaintiff, who received Risperdal treatment from 1999 through 2004, allegedly developed gynecomastia, which caused him substantial emotional distress.  Online reports further reveal that the plaintiff had been prescribed with Risperdal even before the drug was approved for treatment in younger patients.

By 2012, Janssen Pharmaceuticals and J&J have been named defendants of Risperdal lawsuits in courts throughout the US, according to a report at bloomberg.com.  Over 100 lawsuits were reportedly related to gynecomastia.  All of these cases also blame the manufacturing company for not adequately providing warning about the drug’s serious health risks on its information label, including the risk for gynecomastia in pediatric users.

Other Serious Side Effects Associated With Risperdal Intake

The use of Risperdal has also been linked to other serious side effects including movement disorders, such as extrapyramidal symptoms and tardive dyskinesia; and metabolic disorders, such as type 2 diabetes and hyperglycemia.  Medical experts add that Risperdal, including other antipsychotics, may also potentially put patients at risk of sudden cardiac death resulting from abnormal heart rhythm (arrhythmia), and a rarely-occurring adverse effect known as neuroleptic malignant syndrome.  Added information pertaining to lawsuits about Risperdal and other relevant issues are also constantly updated on numerous websites provided by personal injury law firms, such as rotlaw.com by the Rottenstein Law Group.


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