Schizophrenia, bipolar disorder, and autism-related irritability can be debilitating conditions that negatively affect a person and everyone around them. That’s why so many people were hopeful when Janssen released a new antipsychotic drug in the 1990s called Risperdal.
The second-generation antipsychotic was touted as an important drug that was better than existing drugs at the time. Since it was first approved by the U.S. Food and Drug Administration (FDA) to treat schizophrenia in adults in 1993, Risperdal has had its approved uses expanded to include the treatment of bipolar disorder and irritability related to autism in children and adolescents.
Even though risperidone — the active ingredient of Risperdal — made the World Health Organization’s List of Essential Medicines, the antipsychotic drug has been at the center of several controversies.
Not only are patients suing the makers of Risperdal over claims that they experienced unexpected side effects like gynecomastia but the government has targeted Johnson & Johnson and its subsidiary Janssen Pharmaceuticals for marketing the drug for unapproved uses.
Learn more about the side effects associated with Risperdal, why its makers had to pay $2.2 billion to the government, and the status of thousands of Risperdal lawsuits against Johnson & Johnson.
Risperdal is known as a second-generation antipsychotic or atypical antipsychotic. According to the official prescribing sheet for Risperdal, the mechanism of action of risperidone in treating schizophrenia is unclear. However, the drug is believed to help rebalance dopamine and serotonin receptors in the brain.
Dopamine and serotonin are two neurotransmitters that play a role in complex behavior. According to the National Alliance on Mental Illness, rebalancing the two chemicals “improve thinking, mood, and behavior.”
Risperdal comes in several different iterations, such as a tablet, liquid, and injectable medication.
The tablets come in six strength: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. The orally disintegrating tablets come in five strengths: 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. The recommended daily dose depends on the symptoms being treated, but it typically ranges from 1 mg to 6 mg.
Risperdal Consta is an injectable version of risperidone. It comes in four different vial kits and is usually injected into the upper arm muscle or the buttocks once every two weeks.
Risperdal is approved for three uses. The drug was first approved in 1993 for the treatment of schizophrenia. Ten years later, Risperdal was approved for the treatment of bipolar disorder.
In October 2006, the FDA approved the drug for the treatment of irritability associated with autistic disorder. Children and adolescents from 5 to 16 were allowed to take the drug. The following year, the FDA approved Risperdal for the treatment of schizophrenia in adolescents 13 to 17 and bipolar disorder in children and adolescents 10 to 17.
Since its initial approval in 1993, the second-generation antipsychotic has grown in popularity. Johnson & Johnson allegedly took aggressive marketing tactics to increase the use of the drug among approved and unapproved populations — the latter technique would result in a hefty fine from the government.
The marketing and push for broader use helped Risperdal become a colossal hit for Johnson & Johnson. At one point, the drug made $4.5 billion in global sales in 2007 at the height of its use. However, Johnson & Johnson’s patent on risperidone expired the following year in 2008. Several generic versions of the atypical antipsychotic are readily available on the market, but not before Johnson & Johnson made an estimated $18 billion in profits.
Risperdal has been connected to several common but mostly mild side effects. According to Janssen Pharmaceuticals, the most common adverse effects that occurred in clinical trials in more than 5 percent of users was parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.
Along with these common side effects, Risperdal carries a black-box warning — the strongest warning on a label — about the increased mortality in elderly patients with dementia-related psychosis. One test revealed that these patients had a roughly 1.7 times higher risk of death than those taking placebos.
Another serious complication is neuroleptic malignant syndrome (NMS), a potentially deadly condition that’s characterized by rigid muscles, fever, and altered mental state, according to an article in The Neurohospitalist.
Tardive dyskinesia, metabolic changes, hyperprolactinemia, falls, cognitive impairment, seizures, priapism, irregular body temperature, orthostatic hypotension, and dysphagia are all mentioned in the official prescribing sheet.
Although Janssen Pharmaceuticals warns about a wide variety of side effects, Risperdal has been connected to a few additional side effects that have had a negative impact on users, including movement disorders and diabetes.
But, one of the most alarming side effects connected to Risperdal is a condition called gynecomastia. Gynecomastia is a disorder that causes swelling or enlargement in breast tissues in males — one or both.
According to the Cleveland Clinic, it is most commonly caused by a hormone imbalance between estrogen and testosterone. In the case of Risperdal, the enlargement of male breasts is likely due to an increase in a hormone called prolactin.
Risperdal affects dopamine levels in the body. Dopamine works as an inhibitor of prolactin secretion, but the antipsychotic drug blocks dopamine’s effect in the pituitary gland and causes a rise in prolactin. Prolactin can stimulate the growth of breasts and breast milk production in females. Too much prolactin, also known as hyperprolactinemia, can cause similar reactions in males, including excessive breast growth and lactation.
Studies have found an increased risk of gynecomastia in men taking Risperdal, particularly adolescent and young adult males. In a study published in the Journal of Child Adolescent Psychopharmacology, authors looked at a group of men who took risperidone and those who did not. The authors found that current users of risperidone had around four times the risk of developing the disorder than nonusers. In males 18 years or younger, that risk rose to five times greater than nonusers.
Many other studies have also noted elevated prolactin levels in users of Risperdal — a condition referred to as risperidone-induced hyperprolactinemia.
Side effects are common among drugs, but the development of large breasts or abnormal lactation can have a profoundly negative impact on young males. Surgery may be required to reduce the size of some male breasts, and the effects of gynecomastia can be emotionally and psychologically overwhelming.
Studies have pointed out that those with gynecomastia score lower in tests for health, social behavior, self-esteem, and mental health.
That’s why it’s not surprising that thousands of people and their families have taken to the legal system for justice. In a 2018 quarterly report from Johnson & Johnson, the pharmaceutical giant reported that there were 13,500 cases related to Risperdal.
Thousands of cases have been filed in state courts all over the country from people saying that Risperdal caused them to develop breasts and that Johnson & Johnson failed to warn the public about the risks. Other plaintiffs have accused the company of hiding evidence about the dangers and concealing the risks from users.
While the individual lawsuits began piling up against Johnson & Johnson, the U.S. Department of Justice was investigating the marketing practices of the pharmaceutical company.
After a thorough investigation in 2013, the Justice Department announced that Johnson & Johnson had agreed to pay more than $2.2 billion to resolve criminal and civil liability related to Risperdal and two other drugs. The allegations against the company included claims that it had promoted the drugs for unapproved use and provided kickback payments to physicians.
At the time, it was one of the largest healthcare fraud settlements in the country’s history.
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” then U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger said in a statement. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”
Risperdal carries a significant risk for the elderly, but the complaint alleged that Johnson & Johnson and Janssen downplayed the dangers and tweaked studies to make it look like it was safer. Despite repeated warnings from the FDA not to market to the elderly, the pharmaceutical companies continued to target the vulnerable population.
Thousands of cases are still pending in courts around the country, but several juries have already handed down verdicts.
So far, the verdicts have been mostly favorable. Austin Pledger was the first plaintiff to win a Risperdal trial after a verdict awarded him $2.5 million in 2015. The jury found Janssen liable for failing to warn Pledger and his family about side effects. Despite an appeal, a judge refused to throw out the verdict in 2016.
In 2016, a teenager from Tennessee was awarded a $70 million verdict by a Philadelphia jury after he claimed Risperdal caused him to develop large breasts. Andrew Yount started taking Risperdal at the age of 5 and developed gynecomastia. He alleged the company intentionally falsified, hid, or destroyed evidence in the case. It was the largest verdict related to gynecomastia at the time. Another $6.7 million in delay damages was added to the decision later that year.
While other plaintiffs have also secured favorable verdicts, a jury has sided with Johnson & Johnson in one case and judges have thrown out other cases.
In 2015, a jury found that Janssen failed to warn about the risks of Risperdal but did not award any damages to the young man who developed breasts. However, the Supreme Court of Pennsylvania reversed the ruling in 2017 and ordered a new trial.
Although there has yet to be any global settlement related to Risperdal, Johnson & Johnson has reached agreements in several cases.
Aron Banks was set to be the first plaintiff to go to trial in 2012, but just before the trial was about to begin, the company settled the case. Banks started growing breasts while taking Risperdal between 1999 and 2004. He had to have his breasts surgically removed and suffered psychological trauma.
“It’s been a disaster for him and many others who suffered from this,” his lawyer, Stephen Sheller, said at the time. “There are boys who grew breasts as large as ‘D’ cups. There’s a major design defect here, which the judge was going to allow us to pursue, not just the fact that labeling understated risks.”
Along with Banks, Johnson & Johnson has settled with several other plaintiffs for confidential amounts. It is unclear whether the company will come to a global agreement to settle the thousands of pending cases.
Those who have suffered unexpected side effects while taking Risperdal, including gynecomastia, are still encouraged to contact a lawyer to find out their legal options.
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