Johnson & Johnson’s antipsychotic drugs Risperdal, Risperdal Consta and Invega made billions of dollars for the company, but they are linked to serious side effects like breast development in boys (called gynecomastia) and movement disorders such as tardive dyskinesia. J&J already paid millions to the government for improperly marketing Risperdal, and now it faces lawsuits filed by patients. Patriot’s generic risperidone is also linked to these side effects.
Risperdal (risperidone) and Invega (paliperidone) are powerful second-generation antipsychotics approved for the treatment of schizophrenia in adults and adolescents and are both manufactured by Johnson & Johnson's Janssen Pharmaceuticals unit. Risperdal is also approved to treat bipolar disorder in adults and adolescents, and autism spectrum disorders in children and adolescents. Invega is also approved to treat schizoaffective disorder.
Risperdal is also available in a long-acting injection called Risperdal Consta. J&J also released authorized generic risperidone though another of its subsidiaries, Patriot.
These drugs are also used “off label” for attention deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties and depression.
Risperdal was first approved by the Food and Drug Administration (FDA) to treat schizophrenia in 1993, and Invega in 2006. The FDA later expanded their approved uses.
Risperdal was a huge moneymaker for Johnson & Johnson and its Janssen unit, with annual sales peaking at more than $4.5 billion in 2007. Profits declined once J&J lost patent protection, and the company reported only $358 million in name-brand sales in 2012. J&J reported global Invega sales of $424 million for 2010.
|Johnson & Johnson found itself in litigation about Risperdal and Invega because of two developments:|
|The serious side effects of the drugs includes gynecomastia, a condition in which young boys develop large breasts that can require surgery to correct.|
|The drug company promoted the drugs for off-label uses. Investigators are looking into whether J&J marketed these drugs to youths before gaining approval from the FDA to do so.|
Invega is actually a metabolite of Risperdal. The liver breaks down Risperdal into its active chemical ingredients, which are called metabolites. Invega is the most important metabolite of Risperdal. It essentially has the same physiological effect as Risperdal but is metabolized by the body differently.
These drugs are known as “atypical” antipsychotics because they target serotonin in addition to dopamine, which may be why they are more effective than traditional antipsychotics at reducing symptoms. Other atypical antipsychotics include Abilify (aripiprazole), Zyprexa (olanzapine) and Seroquel (quetiapine fumarate).
Risperdal comes as a tablet or liquid. It also comes in injectable form, sold as Risperdal Consta. Invega comes in extended-release tablets. Invega Sustenna is a once-a-month injection that was approved in 2009. These drugs are meant to work on their own, but may be combined with other medications like lithium or an antidepressant in the treatment of depression and bipolar disorder.
Doctors regularly prescribe Risperdal to children with ADHD a condition related to excessive motor activity, inattention and impulsive behavior. These prescriptions are considered off-label. Off-label refers to medication use not approved by the FDA, but there is no law against doctors prescribing a drug for off-label use. According to a 2012 study published in the Archives of General Psychiatry, doctors prescribed the drugs to 70 percent of the children compared to 50 percent of adults.
More than 3.5 million children diagnosed with ADHD take Risperdal and similar drugs despite increasing reports of serious side effects and little clinical evidence these medications offer successful treatment for the disorder.
Some experts also question if ADHD is over-diagnosed and misdiagnosed. A 2010 Michigan State University study showed that as many as 1 million children may be misdiagnosed with ADHD simply because they are the youngest members in their class at school.
Unfortunately, what makes Risperdal and Invega work is also what can cause side effects. They work by altering the levels of dopamine and serotonin in the brain, but they can also cause a number of complications brought on by the abnormal levels of hormones in the body.
Gynecomastia is the enlargement of breast tissue in males, particularly adolescents. Risperdal and Invega greatly increase levels of prolactin, a hormone that stimulates production of milk in pregnant women. This increase may be one reason that boys taking these drugs may experience abnormal breast growth.
One of the most dangerous side effects of Risperdal and Invega is an increased risk of movement disorders such as Extrapyramidal symptoms (EPS) and tardive dyskinesia. These movement disorders are characterized by involuntary and sometimes painful muscle movements. Another disorder, dystonia, also involves uncontrollable sounds.
Both drugs are linked to Type 2 diabetes and high blood sugar.
All antipsychotics carry a risk of sudden cardiac death. The medications carry a black-box warning for increased risk of death in older patients with dementia. Invega is linked to tachycardia (rapid heart rate).
|Atypical antipsychotics also are linked to the following more common side effects:|
|Priapism (prolonged penile erection)||Somnolence||Fatigue|
People suffering from bipolar disorder, schizophrenia and autism spectrum disorders have numerous treatment options. There is no cure, but long-term treatment can help relieve and control symptoms or help people function.
Doctors also prescribe a number of other medications off-label to treat children with autism spectrum disorders, but Risperdal is the only drug approved by the FDA for use in children.
As with all drugs or treatments, caregivers and patients should always discuss possible side effects, benefits and risks in-depth with their health care providers. Every type of medication used to treat bipolar disorder, schizophrenia and autism spectrum disorders carries side effects and risks.
Treatment options for bipolar disorder include:
Treatment options for schizophrenia include:
Treatment options for autism spectrum disorders include:
The two populations at the highest risk for dangerous side effects from Risperdal are children and the elderly. Although Risperdal is approved for each population for certain diseases or conditions, it’s been linked to serious side effects like gynecomastia in boys and death in elderly patients with dementia-related psychosis.
Caregivers and patients should learn as much as they can about the disease or condition before talking to their health care provider about treatment options. The Centers for Disease Control and Prevention, the National Institute of Mental Health and the National Institute of Child Health and Human Development provide comprehensive overviews of each illness online.
Support from friends and family is one of the most important resources for people with bipolar disorder, schizophrenia or an autism spectrum disorder. However, caregivers often suffer fatigue from the large amounts of time and care that patients require. Online resources and support groups for caregivers are available in many communities.
Thousands of individual lawsuits were filed against Johnson & Johnson by patients who say they experienced humiliation and psychological trauma from breast growth resulting from these drugs. The first of these lawsuits to be settled, in September 2012, was filed by Aaron Banks, who suffered breast development as a boy while taking Risperdal from 2000 to 2004. His successful case may be a bellwether for the thousands of other lawsuits that allege breast growth from Risperdal and Invega.
Several similar cases have been settled since then. As Johnson & Johnson faces billion-dollar penalties from federal and state agencies and new evidence emerges in those cases, more former patients are likely to file Risperdal lawsuits.
Following the blockbuster success of Risperdal, federal and state governments forced the drug's manufacturer to pay billions of dollars in lawsuit verdicts and settlements. The problems stemmed from the company's marketing of Risperdal for off-label (unapproved) uses in children in the 1990s and early 2000s.
There are reports of serious side effects from Risperdal and Invega, including gynecomastia (breast development in boys), movement disorders and diabetes. J&J and Janssen have settled several gynecomastia personal injury lawsuits and face thousands more.
Two lots of Risperdal were recalled in 2011 because they were contaminated with chemicals used to treat shipment pallets.
In February 2011, Johnson & Johnson recalled about 70,000 syringes of Invega Sustenna after discovering cracks in the syringes, which could potentially lead to infections or reduced efficacy in users.
One lot of the injectable Risperdal Consta was recalled in 2013 because of mold concerns.