Taking a drug to treat your ADHD shouldn’t leave you with an embarrassing condition. Baron & Budd is investigating a possible connection between the use of the drug Risperdal and gynecomastia. The firm’s Risperdal lawyers currently represent hundreds of patients who took the drugs in several Risperdal lawsuits. To see if you qualify, call a Risperdal lawyer at 866-520-2755 or email us here.
Do You Qualify?
You may be eligible to file a Risperdal gynecomastia lawsuit if you or someone you know experienced breast growth after taking Risperdal before the age of 45. Call our Risperdal lawyers to learn more.866-520-2755 REQUEST YOUR FREE CASE REVIEW
What Went Wrong?
While Risperdal received its first FDA approval in December 1993, it was only approved for the short term treatment of manifestations of psychotic disorder (adult schizophrenia) in adults. In 2003, it received approval for the treatment of acute mania associated with Bipolar I in adults only. Three years later, it was approved for the treatment of irritability in children ages five to 16 with autistic disorder, the only approved use in children at the time. Use for the short term treatment of schizophrenia in children and adolescents and for the treatment of acute manic or mixed episodes associated with Bipolar I disorder in adults, children and adolescents aged 10-17 years was later approved in August 2007.
However, marketing activities for these diverse subgroups began before the drug’s required FDA approval. In fact, the Risperdal lawsuit cites allegations that Johnson & Johnson began targeting doctors who treated children before the FDA had even approved the use of Risperdal for that age group. In addition, while it is illegal for companies to promote their pharmaceutical drugs for “off-label” uses, the Risperdal lawsuit cites allegations that its manufacturer and marketer, Johnson & Johnson, did just that.
Since It Was Approved, Isn’t It Safe?
Unfortunately, the data that Johnson & Johnson submitted to the FDA to obtain its approval has come under question. In particular, a 2003 study sponsored by Johnson & Johnson and published in the Journal of Clinical Psychiatry is under question as the study may have been biased towards its presentation of the data regarding elevated levels of prolactin, a hormone which can cause breast development in males.
In fact, the study failed to mention side effects in adolescent boys and the large elevation of prolactin over a month-long period of treatment, thereby keeping important information out of the hands of doctors treating both children and adolescents.
Risperdal is a powerful second-generation antipsychotic drug manufactured by Johnson & Johnson and marketed by Johnson & Johnson’s Janssen Pharmaceuticals. Currently, Risperdal is approved for the treatment of schizophrenia and bipolar disorder in both adolescents and adults, and autism spectrum disorders in children and adolescents. However, Risperdal is also used off-label for attention deficit hyperactivity disorder (ADHD), sleep difficulties, anxiety and depression.
Risperdal comes in tablet and liquid form, while its injectable form is sold under a different name, Risperdal Consta. While Risperdal is intended to work on its own, it is sometimes combined with other medications such as the mood-stabilizer lithium or antidepressants.
Risperdal works differently than most antipsychotic drugs because it is made to target two neurotransmitters, serotonin and dopamine, in the brain. This may make Risperdal more effective than other drugs as targeting these two neurotransmitters can help decrease psychotic and aggressive behavior. For patients with schizophrenia, Risperdal can even decrease what is known as the “positive symptoms” like hallucinations and the “negative symptoms” like withdrawal.
But there may be an end to the benefits. In fact, the reason why Risperdal may work more powerfully may also be the reason behind its adverse side effects. It’s called hormones. Or, more specifically, Prolactin.
Prolactin is a hormone that is known best for its association with female milk production. It can also trigger something known as gynecomastia, which is the enlargement of breast tissues in males. Most often, gynecomastia occurs in adolescent males. As Risperdal significantly increases levels of prolactin in the body, this may be one of the reasons why males who take Risperdal risk suffering from abnormal breast growth.
The risk of increased prolactin in the body was determined by a panel of federal drug experts to be too high to justify Risperdal’s use in the treatment of behavior disorders like ADHD in children, so at this time Risperdal is only used off-label (in other words, not approved) to treat such behavioral disorders in children, while it is approved for use in children with autism and schizophrenia.
A study published in 2006 in the Journal of Clinical Psychopharmacology warned that, “Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea. Given that the long-term effects of antipsychotic drug-induced hyperprolactinemia are not well documented, especially regarding osteopenia, infertility, growth, and pubertal delay, risperidone should be administered with caution to children and adolescents.”
However, this was not new news for Johnson & Johnson. The Risperdal lawsuit is an important step in the fight for justice to make sure that Johnson & Johnson is recognized for the harm they did:
- concealing risks from patients and doctors and
- illegally and improperly marketing Risperdal for use in children long before the drug was approved for them in 2006.
Pharmaceutical companies cannot hide information from their patients and their doctors, nor can they go against the law that is set to protect patients just to make some more money — or, rather a lot of money.
Instead, it’s time to stand up — for the protection of our children.
In August of 2012, government regulators, attorney generals for 36 states and the District of Columbia settled a lawsuit in which they claimed that Johnson & Johnson illegally marketed “off label” use of Risperdal in children before the FDA had even approved its use for their treatment.
Individual lawsuits from patients who experienced male breast growth resulting from Risperdal are being filed now against Johnson & Johnson. Alleged victims may be entitled to compensation for medical bills, lost wages, mental anguish and suffering.
Young boys who develop breasts as a result of taking Risperal may suffer humiliation and severe psychological trauma. Because of this, some doctors are recommending that adolescent males who suffer gynecomastia undergo surgery. While more mild cases may be resolved with liposuction, some cases require mastectomy.
If you or someone you know experienced breast growth after taking Risperdal, you may be able to file a Risperdal gynecomastia lawsuit.
Current specifications for the Risperdal lawsuit require that the patient began taking the drug before the age of 45. You may contact a Risperdal lawyer at 866-520-2755 or contact us here to learn more.