The Federal Drug Administration has approved the prescription drug risperidone to treat mental health problems. It is an antipsychotic drug that has been successfully used to treat schizophrenia, manic depression, and autism-related irritability in both adults and children.
The goal of the drug Risperdal is to restore chemical equilibrium in the brain, which could improve daily functioning and regulate mood in its users. However, Risperdal can cause side effects, some of which are typical and might be anticipated, while others are abnormal and might have a profound impact on one’s life.
With the assistance of a Risperdal attorney, you may be entitled to financial assistance from the manufacturer for your suffering if you experience gynecomastia or another severe side effect after taking Risperdal, also known as risperidone.
Information Regarding the Medication Risperdal
Risperdal, also referred to as risperidone, is an antipsychotic medication that was first marketed in 1994 and was FDA-approved to treat persons with schizophrenia and bipolar disorders. A Johnson & Johnson subsidiary business called Janssen created this product. When this medication was initially approved, it could only be used by people who had schizophrenia.
The medication was also given the go-ahead in 2003 for the short-term treatment of mixed and manic bipolar disorder-related states. Three years later, adults and children with autism were able to utilize the medication to lessen agitation. The FDA didn’t approve Risperidone for use in children and adolescents until October 2006.
Risperidone is used to treat a number of conditions outside of its approved uses, including:
- Disorder of compulsive behavior
- Depression that is resistant to therapy
- Tourette disorder
- Disorders of eating
- Child behavioral problems
- Acute drunkenness
Risperidone’s exclusive marking rights were revoked in June of 2004 when the Janssen-held patent expired in December 2003, allowing generic drug manufacturers to start selling the same medicine for less money. Risperidone is now available as tablets, oral solutions, and as biweekly injections. This applies to Risperdal Consta and Risperdal M-Tab (disintegrating tablets) (injectable).
Gynecomastia
Gynecomastia, or the enlargement of male breast tissue, is a side effect of Risperdal that has led to multiple lawsuits. It can affect one or both breasts and can be uncomfortable for individuals who have it.
The hormone prolactin, which is produced by the brain and aids in the initiation and maintenance of breast milk in postpartum women, is produced more frequently by the body as a result of risperidone use. The body responds differently when prolactin levels rise in a person who is not breastfeeding.
Symptoms of Gynecomastia
Symptoms include:
- Pain and sensitivity
- Generating breast milk (galactorrhea)
- Drastic weight increase
- Harm to the endocrine system
- Thyroid tumors
Impact
The nipples of the enlarged breast in boys with gynecomastia may also leak a white liquid material. Additionally, sexual dysfunction is more common in males who have developed gynecomastia. Unquestionably, the onset of nipple discharge and breast enlargement in both boys and men can be emotionally upsetting, necessitating contact with a Risperdal attorney.
The majority of the time, the only method to remove the extra breast tissue is through surgery, which carries its own set of hazards. Other surgeries might be necessary since the tissue can grow again even after it has been surgically removed.
Are There Any Studies?
Many adolescent children have used the medication throughout the years, but experts have found a concerning connection between male use of the medication and the emergence of gynecomastia and galactorrhea. This exact issue is covered in the paper “Galactorrhea and Gynecomastia in a Hypothyroid Male Being Treated with Risperidone” in the 1999 edition of Psychopharmacology. Researchers were able to draw a clear correlation between the usage of Risperdal and the growth of a male’s milk production and breast tissues in this study.
Many people who have used Risperdal for a long time noticed raised prolactin levels.
Doctors in this study carefully examined one Hispanic man, 38, who had bipolar disorder due to brain damage sustained in a car accident 20 years ago. The patient’s walking ability was eventually restored, but he also developed behavioral symptoms that had an adverse effect on his moods, impulsivity, and capacity to behave properly in social situations. He was given a prescription for Risperidone and instructed to take 2.5 mg twice daily to alleviate these symptoms. In barely 12 days, the patient claimed to have begun exhibiting symptoms.
His prolactin levels were much higher, and the tests the physicians ran revealed that his breasts had grown larger and were secreting a milky white substance. The patient’s prolactin level on day 13 was 48.2 ng/mL, which was clearly over normal ranges. A normal prolactin level would have ranged from 1.4 ng/mL to 24.2 ng/mL. The following day, the physicians took him off the medication, and over the course of ten days, his levels stabilized.
His breast size had decreased by 75% by day 87, and he had stopped producing the milky discharge. The same kind of study was carried out specifically with children in mind seven years later, and comparable and terrible findings were made.
The study “Risperidone-induced symptomatic hyperprolactinemia in adolescents,” which was also published by Psychopharmacology, indicated that in 3 out of 10 cases, teenagers experienced the same symptoms as adults in their initial study. They came to the conclusion that the clinical effects might result in galactorrhea and gynecomastia.
Other Side Effects of Risperdal
Dizziness, drowsiness, fatigue, and modest weight gain are just a few of the typical Risperdal side symptoms that should prompt contact with a Risperdal lawyer. The development of high blood sugar and irreversible movement problems, which include restlessness and odd movements in the face or shoulders, are serious side effects. They also include difficulties concentrating or remembering things.
Considerable weight gain, significant mood changes, including anxiety, and involuntary muscular tremors are among the more notable adverse effects of Risperdal.
Numerous personal injury claims against the manufacturer, Johnson & Johnson, have been brought as a result of the severe side effects, such as gynecomastia, that users of Risperdal have experienced.
Risperdal Penalties and Legal Action
For the illegal, off-label advertising of Risperdal to children, Johnson & Johnson agreed to pay an FDA penalty of $2.2 billion and more than $1 billion to state governments. Additionally, thousands of males who took Risperdal and experienced gynecomastia have filed cases against Johnson & Johnson. In addition to being found guilty by juries in numerous cases that went to trial, the business has already reached settlements in a number of these matters.
In a number of trials over the past few years, Johnson & Johnson has been forced to make amends for its marketing strategies. In reality, the U.S. Justice Department has been looking into Risperdal’s marketing since 2004 due to claims that the medication was being marketed for unapproved uses. The business consented to pay more than $2 billion to remedy the problem in 2012.
Speak with a Risperdal Lawyer
Do not wait to get in touch with a class action lawyer who is dedicated to seeking justice for injuries brought on by a pharmaceutical company’s negligence if you or a loved one have suffered as a result of side effects from taking Risperdal as a treatment for mental or emotional health difficulties.
You may be entitled to damages if receiving mental and emotional healthcare leaves you with significant pain, particularly if dishonest or deceptive advertising and marketing were to blame.
Your legal options may include pain and suffering damages in addition to any reimbursement for medical expenses you may have incurred.
