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.

Lawsuits Involving Risperdal Adverse Effects

Developed and widely distributed by Johnson & Johnson subsidiary, Ortho-McNeill-Janssen Pharmaceuticals, Risperdal rapidly became one of the most widely prescribed psychiatric medications since it has been released to the United States consumer market about a decade ago, online sources say. On the other hand, as numerous studies and hundreds of adverse-event reports have emerged, the drug’s alleged adverse effects have also elicited mounting Risperdal lawsuits against its manufacturer.

Risperdal, also marketed under generic name risperidone, is an antipsychotic belonging to a newer class of psychiatric medications known as atypical antipsychotics.  It has been initially indicated for the treatment of adult schizophrenia since its market release in 1993 and has been sequentially approved by the US Food and Drug Administration as treatment to adult bipolar disorder in 2003.  The drug’s indications were eventually expanded in 2006 to include symptoms of irritability in autistic children, and further augmented in 2007 to include schizophrenia and bipolar disorder in children and adolescents. While Risperdal may have helped treat symptoms of psychosis in affected individuals, it has also been surrounded with various controversies, prompting questions about its safety and several formal complaints from patients.

Such was the course of action of a former Risperdal user who filed his legal claim in a Pennsylvania court in July 2010, according to legal news sites.  The 21-year old plaintiff was under Risperdal treatment between 1999 and 2004 during which he reportedly developed gynecomastia – a condition characterized by the development of male breast tissues. He claimed of enduring significant psychological distress from growing abnormally large breasts.  Additionally, Risperdal has not been reportedly approved for pediatric use at the time he was treated with the drug.

In 2012, more than 420 lawsuits highlighting Risperdal adverse effects have been lodged against Janssen Pharmaceuticals and its parent company Johnson & Johnson in various courts across the country, according to a previous Bloomberg report.  More than 100 of these lawsuits claim that the use of Risperdal caused users to develop gynecomastia, while all of them allege that the manufacturing company did not sufficiently warn of the drug’s potential risks on its label, including gynecomastia in younger patients. In addition to gynecomastia, other serious health problems such as movement disorders, diabetes, hyperglycemia, heart problems, and even death have also been associated with the use of Risperdal.  Relevant information pertaining to the hazards Risperdal have been reported to cause are also featured on various personal injury law firm sites, similar to the Rottenstein Law Group’s online information center at www.rotlaw.com.

Victoza Use May Lead to Serious Pancreatic Problems, FDA Reveals

Victoza, a top-selling diabetes drug developed by Denmark-based pharmaceutical firm Novo Nordisk, has been increasingly associated with potentially adverse health risks among its users, according to online news reports. As a result, some medical experts from different medical communities have reportedly started to raise questions about the safety of the medication. These problems have also warranted the scrutiny of the United States Food and Drug Administration and a number of potential Victoza lawsuits from patients who claim of suffering from injuries from the drug.

Early this year, the US FDA warned the public that Victoza (liraglutide), as well as other incretin mimetics, may be potentially linked to serious health problems related to the pancreas, online sources say. The FDA indicated in a drug safety communication in March that this type of medications bears the propensity to cause pancreatitis or inflammation of the pancreas, and cellular changes that may lead to cancer. This was reportedly released following an unpublished study of medical researchers who analyzed samples of pancreatic tissues from patients whose cause of death was undetermined.

Incretin mimetics are a type of medications used to treat diabetes mellitus type 2 or type 2 diabetes — a metabolic disorder marked by increased blood sugar or glucose levels. Dubbed by many experts as wonder drugs for the said condition, incretin mimetics mimic the same incretin hormone known as glucagon-like peptide 1 (GLP-1), which play a vital role in producing more insulin in response to an increase in glucose. Insulin, on the other hand, lowers blood sugar levels by helping the body use glucose for energy.   Other incretin mimetics widely distributed in the US also include Byetta by Amylin Pharmaceuticals and Januvia by Merck.

This was not the first time that Victoza has been hounded by controversies concerning its safety. In fact, Public Citizen, a consumer rights advocacy organization, has even disagreed with the FDA’s decision to approve the drug in January 2010. The Washington, DC-based group petitioned the government agency to take the product off the market, saying that it may put patients susceptible to an increased risk for adverse health problems, including kidney failure and even thyroid cancer, according to a Reuters report. Previously conducted studies have also revealed that pancreatitis occurred more often in patients who were prescribed with Victoza than those who used other similar drugs.

Nevertheless, the FDA came to the conclusion that the benefits of Victoza substantially outweigh its known risks. Despite that, numerous patients who may have been injured by the drug are reportedly contemplating on filing a lawsuit involving Victoza side effects. Added information related to safety issues concerning Victoza may also be found on various personal injury law firm sites, including the Rottenstein Law Group’s online information center found at www.rotlaw.com.

A Rundown of the Potential Side Effects Linked to Victoza

Victoza, otherwise known by its key ingredient liraglutide, is an injectable medication prescribed to people suffering from a metabolic disorder known as diabetes mellitus type 2.  It belongs to a relatively new group of anti-diabetes medications known as incretin mimetics, agents that mimic incretin hormones that trigger the body to produce more insulin, which in turn, helps improve blood sugar levels, according to medical experts.  Victoza, being one of the few revolutionary diabetes medications available in the United States, has reportedly shown a steady rise in the number of its prescriptions following its release into the consumer market in January 2010.  In fact, it has earned $1.7 billion in sales for global healthcare products provider Novo Nordisk in 2012, according to a Bloomberg report.  However, mounting issues about its safety have also reportedly had numerous patients considering a potential Victoza lawsuit against the Denmark-based pharmaceutical firm.

Common Side Effects of Victoza

Victoza is a once-daily injectable drug that may also be used in combination with other blood glucose level controlling formulations including sulfonylureas, thiazolidinediones, and metformin.  Similar to other medications, Victoza is not devoid of unwanted effects.  Some of the most common side effects that may occur as a result of Victoza use include:

• Dizziness
• Headache
• Vomiting
• Nausea
• Loss of appetite
• Upset stomach
• Constipation
• Diarrhea
• Back pain
• Skin redness or rash at the injection site
•  Cold symptoms (sinus pain, sneezing, stuffy nose, sore throat)

Victoza, Other Incretin Mimetics Tied to Serious Pancreatic Complications

In March 2013, the US Food and Drug Administration released a drug safety communication indicating that it is conducting an investigation in relation to serious pancreatic health problems linked to incretin mimetics, according to online news reports.  The federal agency is evaluating unpublished scientific findings suggesting that patients taking incretin mimetics, such as Victoza, may stand at an elevated risk of inflammation of the pancreas (pancreatitis), and cellular changes that could develop into cancer.

As the federal agency has yet to reach new conclusions pertaining to the safety of incretin mimetics, patients were advised to continue taking their medications as instructed unless directed otherwise by their prescribing physicians.  On the other hand, some patients who may have encountered similar health problems from Victoza have reportedly begun consulting legal experts about a potential lawsuit against the manufacturer of Victoza, Novo Nordisk.  Personal injury attorneys who know more about legal issues and other concerns related to Victoza also maintain informative websites, similar to rotlaw.com by the Rottenstein Law Group.