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Risperdal® (risperidone)

Gynecomastia (breast development in boys)

Gynecomastia: in boys and young men, growth of breasts that may require a partial or full mastectomy, surgical removal. Risperdal® (Risperidone) has been linked to serious and potentially permanent side effects or death. One of the class of atypical antipsychotic drugs, Risperdal® was originally approved for use in adults with schizophrenia and, later, for treatment of acute mania or mixed episodes associated with bipolar disorder in adults. Risperdal® is manufactured by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.; the generic version, risperidone, is made by other manufacturers.

Boys may be at particular risk of growing breasts (gynecomastia) that require surgery

While anyone taking Risperdal® may be at risk for harm, children and the elderly are at a significantly higher risk.  Some children have experienced the significant, dangerous and potentially permanent side effects listed above. Children are especially at risk for additional side effects including severe weight gain, extreme rapid onset of diabetes and other blood disorders, and more pronounced movement disorders including tardive dyskinesia.

Free, no obligation legal consultation

Sheller, P.C. attorneys continue to provide free consultations to families whose sons have been diagnosed with or who are suspected of having gynecomastia.

 

NEWS UPDATE, February 17, 2012: A trial in New Jersey claiming Risperdal causes diabetes is underway. While this is not related to the Sheller, P.C. investigation and legal action being taken on behalf of boys who have developed breats (gynecomastia) it is of note as litigation involving the manufacturer of Risperdal, Johnson & Johnson.

 

NEWS UPDATE, January 18, 2012: Bloomberg Business Week is reporting on the J&J Trial in Texas -- J&J Pushed Risperdal for Kids Without Approval, Memo Shows (Jan 17), J&J Marketed Risperdal for Kids After FDA Warnings, Jurors Told (Jan. 16), J&J Said to Agree to Pay $1 Billion in Risperdal Marketing Probe (Jan.6)

 

A complete list of potential side effects for both children and adults is listed below, but of particular concern:

Boys may be at particular risk of breast development (gynecomastia). Due to an increase in the amount of a certain hormone (prolactin) in blood boys may experience growth of breast(s), possibly with pain or nipple discharge. A mastectomy may be required to remove the breast(s).

 

NEWS UPDATE, August 10, 2011:  Johnson & Johnson reached an agreement to settle a misdemeanor criminal charge related to marketing of its antipsychotic drug Risperdal®  according to Bloomberg News. The company has been under investigation since 2004 for sales practices including marketing the drug for unapproved uses. The company acknowledged in a quarterly filing that the Justice Department and the U.S. Attorney in Philadelphia "are continuing to pursue both criminal and civil actions." 

 

Sheller, P.C. attorneys continue to pursue justice for individuals harmed by Risperdal. 

 

NEWS UPDATE, March 21, 2010: A South Carolina jury concluded.that the manufacturer of Risperdal®, a unit of the New Jersey based Johnson & Johnson violated consumer-protection laws by sending South Carolina doctors a misleading letter about the safety and effectiveness of the antipsychotic drug Risperdal®. The attorneys at Sheller, P.C. have filed lawsuits about the drug and continue to build cases for other clients harmed by Risperdal®. Bloomberg story: "J&J Duped South Carolina Doctors Over Risperdal"

 

NEWS UPDATE, September 2010: Sheller, P.C. attorneys are intensifying the investigation into the link between the drug Risperdal in gynecomastia, breast development in boys and adolescent males.  Stephen Sheller, founding partner of the law firm, has been interviewed by major print and broadcast media on the ongoing litigation and is considered a vital advocate for children affected by dangerous drugs

 

NEWS UPDATE: In early January 2010, Sheller, P.C. filed suit against the manufacturers of the antipsychotics Risperdal® and Invega® on behalf of boys and young men who experienced serious side effects from the drugs including gynecomastia, the growth of breasts. Also named is the company involved in publishing "ghostwritten" studies they should have known were misleading or exaggerated in favor of the drug manufacturer. The legal actions filed by Sheller are among the first to hold ghostwriters responsible for harm to consumers.
 
Sheller, P.C. attorneys are investigating these side effects of Risperdal® in boys: 
  • Gynecomastia: in boys and young men, growth of breasts that may require a partial or full mastectomy, surgical removal
  • Production of prolactin, a hormone that can cause gynecomastia, changes in boys related to feminine hormonal and physical characteristics

 

 

Other potentially dangerous and permanent side effects can include:
  • Pituitary tumors
  • Tardive Dyskinesia: an involuntary movement syndrome involving uncontrollable muscle movement of the arms, legs, tongue, face, mouth or jaw. Some of the specific uncontrollable movements in the face may include tongue sticking out, puffing of cheeks, mouth puckering and chewing movements
  • Neuroleptic Malignant Syndrome (NMS): a possibly fatal syndrome, with symptoms including stiff muscles, sweating, fever, confusion, abnormal thinking, and fast or irregular heartbeat
  • Increased risk of sudden death from heart attack (cardiac arrhythmias and other cardiac causes)
  • Diabetes, hyperglycemia and other blood sugar side effects and abnormalities, particularly in children and the elderly
  • Weight gain, potentially rapid and extreme
  • Suicide, suicidal thoughts
  • Pancreatitis
  • Bone Loss (including early osteopenia/osteoporosis)
  • Cellulitis: increased edema (swelling) that may be severe enough that it increases the risk of cellulitis, a severe inflammation of often several layers of skin and connective tissue
  • Neutropenia: Decreased white blood cell count which can harm the immune system and contribute to cellulitis and other infections
  • Increased mortality in the elderly with dementia and related psychosis.

Though approved for adults, until recently the use of Risperdal® in children was not approved by the FDA and only approved now for very limited use in pediatric patients. 

If doctors believe a drug can be an effective treatment for a patient’s condition, they can prescribe the drug “off label,” meaning they may indicate the use in a population not approved by the FDA.  In the last few years, Risperdal® has consistently been prescribed “off label” for children to treat autism, irritability, aggression and other behavior disorders including Attention Deficit Disorder/Hyperactivity Disorder (ADHD). Risperdal® has also been prescribed to treat irritability, aggression and other behavior disorders in the elderly.

 

"Risperdal®  should be a drug of last resort. The adverse event profile is so significant, you don't want to use it except as a last resort. There are many alternatives to these kinds of drugs. But 'big pharma' and the FDA have failed to protect the public" - Stephen Sheller on The American Law Journal.
 
Attorneys of Sheller, P.C. are currently investigating these cases with particular attention to harmful side effects in children

If you, your child or someone you know has experienced and/or has been diagnosed with any of these side effects while taking Risperdal® or any other antipsychotic medication such as Invega®, Geodon®, Seroquel® or Zyprexa®, contact us now to learn your rights and protect your health or the health of your child.

 

Related Information

Johnson & Johnson Reaches Agreement with U.S. on Risperdal Criminal Charge Bloomberg News, August 10, 2011

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Related Media
Risperdal® (risperidone)
Sheller, P.C. lead attorney Stephen Sheller was featured in an interview by the CBS Evening News with Katie Couric in 2009 on the dangers of using Risperdal® in children.

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