By Robert J. Boumis  |  December 10, 2013

Category: Legal News

iStock_Man-covering-chestThe U.S. Food and Drug Administration or FDA has announced that Janssen Pharmaceuticals Inc. pleaded guilty to misbranding their drug Risperdal, amid allegations that the drug can cause male breast growth (gynecomastia).

Risperdal is considered an atypical antipsychotic, a newer generation of psychotropic medications designed to cause fewer neurological side effects than older-generation antipsychotic drugs. However, clinical trials have found an increased risk of certain other serious side effects, including death in patients with dementia and the development of breasts in young men who took the drug. The exact mechanisms of these serious medical conditions are not fully known, but it is believed that the drug triggers an increase in prolactin, a hormone that regulates breast growth in females under normal circumstances.

Risperdal was approved as a drug to treat schizophrenia or other psychiatric disorders, including bipolar disorder. However, the manufacturers allegedly began to market the drug for unapproved purposes, including the treatment of dementia in the elderly and behavioral difficulties in children. The drug was not approved or thoroughly tested in either population, and studies have linked the drug to serious side effects in these populations. Under the terms of the criminal case, the manufacturers will be fined billions in penalties for improperly and illegally marketing their drugs.

In addition to issues with marketing the drug, Risperdal has been linked to the growth of male breast tissue. This condition, known clinically as gynecomastia and informally as “man boobs,” comes with a variety of painful and embarrassing side effects, including painful, tender breast growth, as well as nipple pain and lactation. The drug is also associated with the risk of delayed puberty.

Hundreds of Risperdal lawsuits have been filed against Janssen Pharmaceuticals, a unit of pharmacological behemoth Johnson & Johnson. More than a quarter of these lawsuits are connected with alleged cases of gynecomastia. This condition can lead to finical burdens, including medical costs for surgery, other medical expenses and psychological treatment. The Risperdal lawsuits further allege that manufacturers downplayed these risks, preventing patients and their prescribing physicians from having the information they needed to make informed decisions regarding their medical care.

Many patients who suffered from gynecomastia may not be aware of the exact cause of their male breast growth or “man boobs.” If you are a male and took Risperdal between the ages of 10 and 18 and experienced the growth of breasts, nipple pain or lactation, you may qualify for compensation. You can start to explore your options by visiting the Risperdal Side Effects, Male Breast Growth Class Action Lawsuit Investigation. Here, you can fill out a short form for review by a legal expert with a background in this kind of litigation. The initial consultation is completely free of charge, and from it, you can receive additional guidance on the best steps to take in your exact situation.

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

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