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Risperdal®: Risk of Breast Development in Boys

Has your son or a boy you know taken Risperdal®?

Boys may be at risk for a serious, potentially irreversible side effect called Gynecomastia.

Gynecomastia is a condition where boys grow breasts.

Risperdal® may increase the amount of a hormone (prolactin) in blood. Symptoms may include growth of breast(s), possibly with pain or nipple discharge. A mastectomy may be required to remove the breast(s).

Sheller, P.C. attorneys are investigating cases involving the development of gynecomastia (breast growth) in boys and male adolescents because the initial and updated labeling precautions and subsequent warnings were totally inadequate to inform patients of the potential severity of the risks.

Know The Risks:

Gynecomastia

Research indicates that use of Risperdal® elevates the hormone prolactin, which is one of the reasons why the drug causes boys and male adolescents to develop the serious and potentially irreversible condition gynecomastia (breast development). Prolactin is a protein hormone that induces and maintains lactation in women after they give birth. In addition to breast growth, elevated prolactin may increase the risk of breast cancer in young boys and adolescents and harm the male reproduction system.


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The antipsychotic drug Risperdal® was originally approved by the FDA for use in adults with schizophrenia. The drug was used "off-label" in children and adolescents, meaning it had not been approved by the FDA, for bipolar disorder, autism, irritability, aggression and behavior disorders including Attention Deficit Disorder/Hyperactivity Disorder (ADHD).

The manufacturer of Risperdal® applied for approval for use in children and adolescents for certain conditions. In October 2006, the FDA approved the use of Risperdal for irritability associated with autistic disorder in children and adolescents. Additional approval in August 2007 was for treatment of acute mania or mixed episodes associated with Bipolar 1 disorder in children and adolescents.

Both "off-" and on-label use did not, in Sheller, P.C.'s investigation, provide adequate warning of the drug's dangerous side effects.

If your son or a young boy or adolescent you know has experienced abnormal breast development or has been diagnosed with gynecomastia, contact us now to learn your rights and protect the health of your child.

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Additional Risks

At this time, Sheller, P.C. attorneys are specifically investigating gynecomastia, but Risperdal® has been linked to other serious conditions and side effects.

If you have any of the following side effects, consult your health care professional:

  • Involuntary muscle movements (extrapyramidal symptoms/ tardive dyskinesia)
  • Neuroleptic Malignant Syndrome (NMS)
  • Diabetes

About Sheller, P.C.

The firm of Sheller, P.C. is nationally recognized as committed to the aggressive and compassionate representation of its clients. Sheller, P.C. maintains a practice concentrating in areas of drug product and medical device liability, medical malpractice, pharmaceutical whistleblower cases, toxic tort and complex catastrophic personal injury litigation, consumer product safety and fraud, equality and compensation.

Attorneys from Sheller, P.C. have successfully litigated groundbreaking cases dealing with everything from pharmaceutical products, medical devices, tobacco company fraud and consumer electronics fraud to racial discrimination and birth defects. In just fifteen months of 2009-2010, Sheller, P.C. attorneys were instrumental in the recovery of $4.2 billion for the federal government representing whistleblowers in pharmaceutical fraud, failure to warn and off-label marketing cases. Their successes have garnered press coverage from the CBS Evening News, Fox News (National), CNN, MSNBC, Good Morning America, The New York Times, Wall Street Journal, Washington Post, Los Angeles Times and Philadelphia Inquirer, among many others.

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Risperdal® Video

Risperdal CBS News Video

Sheller, P.C on national news media regarding Risperdal®: CBS Evening News, American Law Journal, Al Jazeera and more.
Warning: this video contains graphic images.


Response Form

*required    †phone or email required
Full name of child (boy)*:
Address*:
City*:
State*:
Zip*:
County:
(if applicable)
Date of birth*:
Contact Person Full Name*:
Contact Person's Relationship to Child (boy)*:
 
Home Phone:
Mobile Phone:
Email:
The child was first prescribed Risperdal®*:
Before October 2006
Between October 2006 and August 2007
After August 2007
Has the child (boy) developed breasts while taking Risperdal®?
  Yes  No
Has the child (boy) lactated (leaked breast milk) while on or after stopping Risperdal®?
  Yes  No  Not sure
Has the child (boy) been diagnosed with gynecomastia?
  Yes  No  Not sure
Did the child (boy) have elevated prolactin?
  Yes  No  Not sure
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