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Risperdal (risperidone) is commonly prescribed to adolescents who are diagnosed with mental health issues such as bipolar disorder and autism. Risperdal is used to lessen the symptoms associated with schizophrenia, as well as acute mania and mixed episodes associated with Bipolar I Disorder; it has been cleared for use in adults and teenagers older than 13. It has also been prescribed to children aged between 5 and 16 who are dealing with irritability associated with an autistic disorder.

Risperdal was originally approved by the U.S. Food and Drug Administration (FDA) to treat adults with schizophrenia. Following its introduction, Johnson & Johnson, through its subsidiary, Janssen Pharmaceuticals, expanded its use in children to treat a wide range of mental health and behavioral issues. In many cases, use of the drug was “off-label,” meaning the drug was used for indications that were not tested through clinical trials or approved by the FDA.

Is Risperdal a Dangerous Drug to Take?

Currently, there is a lot of debate about the safety of the drug Risperdal. In 2000, a study was published titled “Galactorrhea and gynecomastia in a hypothyroid male being treated with risperidone” that looked into a possible link between males taking risperidone and gynecomastia, which is the enlargement of male breast tissue. In the study, a 38-year-old man diagnosed with bipolar mood disorder was prescribed 2.5 mg of risperidone to take twice per day. After 12 days, he was suffering from enlarged breasts as well as galactorrhea, which is the discharge of milk from the breast. This has led to numerous lawsuits being filed; for example, J&J confidentially settled 6 lawsuits in 2012. In one of these, the plaintiff’s attorney stated the drug caused his client to grow “D” cup breasts.

Boston Children’s Hospital conducted a study involving 47 boys with gynecomastia and 92 without between the ages of 12-21. The study showed that the boys with gynecomastia exhibited increased feelings of restlessness, loneliness, physical limitations, pain, tension and eating disorders relative to the boys without the condition. The researchers in the study concluded that gynecomastia significantly and negatively impacted the boys’ psychological well-being and that boys with the condition are more likely to have impaired social functioning, mental health and self-esteem.

The Drug Companies Knew Of This Side Effect Associated With Risperdal

Janssen Pharmaceuticals and Johnson & Johnson were aware of the risks of Risperdal when the FDA approved the drug in 1993. However, from 1999 to 2005, Risperdal was marketed and prescribed to adolescents, including young men, even though the FDA did not approve it for limited use among youths until 2007.

What Should I Do If I Am Taking Risperdal?

Do not suddenly stop taking Risperdal unless you have talked with a physician. Reducing dosage should be done with physician supervision so your body can adjust properly. If you stop taking it immediately, you may suffer other serious withdrawal symptoms like insomnia, irritability and hallucinations.

How Do I Know If I Am Having This Serious Reaction To Risperdal?

If you are noticing an unnatural growth of breast tissue as a male, you may be experiencing gynecomastia as a result of taking Risperdal. One of the most alarming side effects of risperidone is galactorrhea, which is the spontaneous flow of milk from the breasts that is not associated with pregnancy. Studies have shown that the taking of risperidone can lead to elevated levels of prolactin in the blood (hyperprolactinaemia), which can lead to galactorrhea. This has been found in both women and men taking risperidone  Prepubescent females also sometimes experience nipple discharge or lactation as a result of taking Risperdal. It is wise to consult a physician to have your symptoms recorded and develop a plan of action.

Will I Have Any Problems If I Stop Taking Risperdal?

You may suffer temporary withdrawal symptoms if you immediately stop taking Risperdal completely. Change your medication schedule only after consulting your physician and discussing your concerns. It is important that you are cautious when reducing dosage of any medication.  It is not recommended that you stop taking the drug “cold turkey” without medical supervision. Some symptoms of Risperdal withdrawal can include agitation, anxiety, dizziness, insomnia, itching, nausea, and more.

Can I Take Any Action?

For young males who developed enlarged breasts after taking Risperdal, the results were devastating. Young boys who have developed breasts as result of Risperdal use can suffer from severe psychological trauma. Many experienced teasing and embarrassment, affecting their quality of life and mental health. As a result, many doctors have reportedly recommended that adolescent males who suffer from gynecomastia undergo surgery. Mild cases can be resolved with liposuction, while more severe cases will require a mastectomy.  This unnecessary treatment exposes the young males to the risk of complications, scarring and, in some cases, permanent disfigurement.

Risperdal lawsuits across the country have led to significant settlements and jury awards for boys and young men. Johnson & Johnson has paid over $2 billion in criminal and civil penalties related to marketing practices associated with Risperdal and two other related drugs.

If you have suffered from the harmful side effects of Risperdal in New York, you may be entitled to compensation to cover the costs.  In order to determine if you have a valid product liability claim against the manufacturers of Risperdal, you should contact The Law Offices of Effie Soter, P.C. to schedule a free consultation to discuss your rights. Call us at 646-504-7384 or contact us via email to learn more about your rights so that we can obtain the best outcome for you.