Amanda Antell  |  April 24, 2015

Category: Legal News

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iStock-Risperdal-Lawsuit

Risperdal is a popular atypical antipsychotic that is regularly prescribed to adults and children alike, to manage the symptoms of their extreme mood disorders. Recently, Risperdal has been linked to a number of severe side effects, most infamously being gynecomastia (male breasts).

Atypical medications like Risperdal are typically prescribed to patients who have either not responded well to first-choice medications, or to patients who are susceptible to side effects.

Risperdal works by channeling a particular brain chemical called dopamine, which controls the brain’s pleasure and rewards sensors. By leveling only this one pathway, the mental side effects are far less severe than traditional antipsychotics, which aim to stabilize the brain as a whole. For this reason, patients and physicians have complimented Risperdal for being an efficient treatment with limited side effects.

The wide marketing success has earned billions for manufacturing company Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, but has also earned the company equal scrutiny. Janssen Pharmaceuticals has been repeatedly criticized for illegally marketing Risperdal for pediatric use before it was approved by the FDA to do so, to which many experts believe has led to the Risperdal gynecomastia epidemic.

Risperdal was approved by the FDA in 1993 to treat adult patients with schizophrenia and bipolar disorder, but was later approved to treat children with similar conditions in 2006. However, Janssen had reportedly begun marketing Risperdal soon after its release to other audiences, after discovering that physicians were commonly prescribing Risperdal to children after first-choice medications heeded no results. Seeing a potential target market, Janssen Pharmaceuticals began selling Risperdal to physicians for pediatric purposes.

While it is not illegal for physicians to prescribe medications for off-label uses, it is illegal for drug companies to advertise them for such purposes.

Medical experts point out that one of the reasons why Risperdal was not initially approved to treat children was because it was unknown as to how it could affect them. As early as 2011, reports of boys developing breasts had flooded the FDA, indicating that the gynecomastia occurred soon after the boys started Risperdal.

Overview of Risperdal Gynecomastia Complications

Gynecomastia is when males develop abnormal breasts tissue, which can become as enlarged as D-cups. It is a highly troublesome condition that is both embarrassing and confusing to young boys, who are often at the point of adolescence, which is the epitome of physical development in children.

While not a fatal condition, gynecomastia can mean testosterone depletion in adult men, and has even been associated with certain types of cancers.

Unfortunately, gynecomastia is not an easily treatable condition, often needing surgical intervention to expel the excess chest tissue; even after removal surgery, boys are often left psychologically traumatized and need counseling.

The symptoms of gynecomastia include:

  • Pain and Tenderness in Breast Area
  • Swelling or Enlargement of Nipples
  • Growth of Breasts
  • Lactation or Discharge of Nipples

While medical experts are unsure of the exact cause, it is most likely linked to a hormone imbalance of prolactin, which is the hormone linked to female breast development.

Risperdal controls psychotic symptoms by leveling the brain’s dopamaine levels; dopamine is manufactured in the body’s pituitary gland. The pituitary gland is responsible for manufacturing and regulating many hormones in the body, including prolactin.

Healthcare experts theorize that when Risperdal disrupts the natural flow of dopamine from the pituitary gland, it also interferes with the natural production and processing of prolactin.

As mentioned before, prolactin is responsible for stimulating breast development in adolescent girls, and is also responsible for causing lactation in pregnant and nursing women.

Ideally, women are at their highest prolactin production is when they have recently given birth and are nursing, but high prolactin can also cause problems for girls and women too. When female patients have their pituitary glands interrupted it can also lead to high prolactin levels that cause similar side effects of gynecomastia; they can prematurely develop breasts, can lactate despite not being pregnant, and even develop pituitary tumors.

Even though young boys naturally have small levels of prolactin, Risperdal can lead to them having as much as a lactating woman. Risperdal is well-known as a prolactin-increasing drug, but that had not been previously stated on Risperdal’s label or advertisements.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Risperdal attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Risperdal class action lawsuit is best for you. [In general, Risperdal lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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If you or your son took Risperdal between the ages of 10 and 18 years old and suffered gynecomastia (male breast growth), male breast pain, nipple pain, or nipple discharge, you may be entitled to compensation. See if you qualify by submitting your information below for a free and confidential case review.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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