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Risperdal Swollen Male Breasts Lawsuit Information
Facts about Risperdal Gynecomastia
Table of Contents
Gynecomastia is much more than abnormal tissue growth. Changes to the hormonal balance in the body can cause health issues and have a detrimental effect on your psychological well-being. Even in less severe cases, gynecomastia can impact your body image, how you interact socially and intimately, and even how you feel about life in general.
If you are reading this guide because you or someone you love is suffering from gynecomastia, then you already know how it can change someone’s life. This guide was written to help you learn more about the condition as a side effect of the drug Risperdal and what you can do if you or someone you love has been diagnosed with gynecomastia.
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What is Risperdal?
Risperdal, generic name risperidone, is an atypical antipsychotic medication used to treat mental and mood disorders. It was designed to bring the natural substances in the brain into balance, to help patients think clearly and be able to function better when engaging in activities of daily life.
Risperdal was approved by the U.S. Food and Drug Administration in 1993 for short-term use in adults with schizophrenia, and in 2003 for short-term use in adults with acute manic episodes. In 2006, the FDA approved the drug for the first time for use by children and adolescents as a treatment of the irritability that may occur with autism.
In 2007, the FDA approved Risperdal for the treatment of schizophrenia in adolescents age 13 to 17, and for the short-term treatment of manic episodes in children and teens aged 10 to 17. Risperdal is used “off-label” without FDA approval for depression, anxiety, sleep issues, and attention deficit hyperactivity disorder (ADHD).
How Does Risperdal Work ?
Risperdal is prescribed in either tablet or liquid form. The injectable form is sold as Risperdal Costa. These drugs are categorized as second-generation atypical antipsychotics because they target serotonin and dopamine receptors whereas first-generation antipsychotics target only dopamine receptors and have a greater risk of side effects. and hour violations in 79 percent of agency-initiated investigations amounting to an average of $8,900 in wage violations. This is a 21 percent increase in the number of violations and the amount of back wages owed from 2009.
Who Makes It?
Risperdal is made by Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. The company has made billions in sales of the antipsychotics Risperdal, Risperdal Consta, and Invega. However, these drugs have been associated with gynecomastia, and other serious side effects such as diabetes, tardive dyskinesia, extrapyramidal effects, metabolic syndrome, and sudden cardiac death.
What is the Biological Half-Life of Risperdal?
Risperdal is metabolized in the liver by an enzyme called CYP2D6 and is excreted from the body in urine and to a lesser extend through feces. However, some individuals do not metabolize the drug as quickly as others, leading to a much longer half-life. In fast metabolizers, the half-life of the drug is as little as three hours, while in poor metabolizers, the half-life is up to 20 hours. However, the half-life for the “active fraction” is about 20 hours in fast and poor metabolizers. Bear in mind that Risperdal can store in the body fats and continue to have an effect on the body for an extended period of time after the drug is stopped.
What is Gynecomastia in Boys?
Gynecomastia is the abnormal development of breast tissue in men. It commonly seen in newborns and again in puberty because of the fluctuation of female and male hormones. It can affect both breasts, though not always equally, or it can occur in one breast. Typically, in these cases, gynecomastia resolves on its own as the child goes through puberty. Gynecomastia is also sometimes seen in men over 50 also because of natural hormone changes.
However, gynecomastia can also be caused by heroin or marijuana drug abuse, some supplements, and medications like Risperdal. In fact, not only can Risperdal cause gynecomastia, but it can also cause a significant increase in prolactin, the hormone that allows pregnant women to make milk, which leads to leaky breasts in males.
How Does Gynecomastia Afect Boys?
Studies show that even mild gynecomastia can have a negative effect on mental and emotional health, including the boy’s self-esteem, mental health, social functioning, and general health. In fact, researchers found that “Merely having gynecomastia was sufficient to cause significant deficits” in these areas. Study authors recommend early intervention and treatment to help improve the psychological and emotional health of the male. One major problem area is that breast reductions are often considered a cosmetic procedure that many insurance companies do not cover, leaving many boys without the financial means to have corrective surgery.
Why are There Lawsuits over Risperdal?
Thousands of lawsuits have been filed against Johnson & Johnson over Risperdal because of how they marketed the drug, including for use in children before the drug was approved by the FDA for use in children. These cases all allege that the company failed to warn about serious Risperdal side effects including the development of gynecomastia in males and that the company played down the risks of the drugs.
Has J&J Settled Any Risperdal Cases?
More than 1,500 lawsuits have been filed against J&J, but only a few have been heard by the courts. However, the company has settled several major investigations by state and federal entities. In fact, J&J the company settled allegations by the Department of Justice for 2.2 billion in 2013 for illegal off-label marketing of the drug including claims that the company pushed physicians to use the drug to treat teens and children when the drug was not approved by the FDA for use in these groups.
J&J also settled illegal marketing claims with more than 30 states for $180 million and then reached a settlement with Texas for $158 million. In 2016, the U.S. Supreme Court declined to hear J&J’s appeal of a $124 million South Carolina verdict over Risperdal illegal marketing allegations.
Verdicts & Awards
In one of the first Risperdal gynecomastia cases to go to trial, the jury awarded the plaintiff $2.5 million after finding the drug caused the teen to develop size 46DD breasts. In November 2015, another jury awarded the plaintiff $1.75 million over Risperdal allegations.
In July 2016, a Philadelphia court awarded the plaintiff $70 million in damages, an amount far greater than awarded in other cases. In all these cases, the plaintiffs said they grew breasts after using Risperdal, and that J&J knew the medication could cause gynecomastia but failed to report this to the FDA. In fact, J&J did not add a gynecomastia warning label until 2006.
How to Get Help
We are dedicated advocates for the rights of those who have been harmed by medications like Risperdal. Far too often, the men and boys affected by Risperdal are left with physical injury and mental scars that require a significant financial investment to try to fix. We believe J&J should be responsible for those injuries and scars and the give you the maximum compensation available so you can begin to heal without suffering a financial burden.
Our firm has spent decades fighting big pharma who puts profits over the safety of the patients who need them most. We hold them accountable for –
- Current and Future Health Care Costs
- Pain and Suffering
- Psychological distress and emotional anguish
If you or someone you love is suffering from Risperdal Gynecomastia, call us today. We will get through this together.
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