Johnson & Johnson’s antipsychotic drugs Risperdal and Invega made billions of dollars for the company, but they are linked to serious side effects like breast development in boys (called gynocomastia) 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.
Risperdal (risperidone) and Invega (paliperidone) are powerful second-generation antipsychotics approved for the treatment of schizophrenia in adults and adolescents. 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.
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 over Risperdal and Invega because of two developments:|
|The serious side effects of the drugs includes gynocomastia, 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.
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|
Although doctors may prescribe medications for “off-label” (unapproved) uses, the law prohibits companies from actively promoting or marketing drugs for such uses. One example of off-label use is when some doctors prescribe Risperdal or Invega as a treatment for ADHD.
A panel of federal drug experts found the risks of Risperdal too profound to justify its use in treating behavioral disorders in children, so use of the drug to treat ADHD and other behavioral disorders remains off-label despite approval of the drug for use in children’s schizophrenia and autism.
Government regulators and attorneys general for 36 states and the District of Columbia settled a lawsuit in August 2012 in which they claimed that Johnson & Johnson illegally promoted off-label use of the drug in children before the FDA approved it for younger patients. The charges included paying physicians to give favorable speeches, paying for golf outings for doctors and giving bonuses to salespeople who marketed the drug to pediatric doctors. Doctors who promoted Risperdal for children were also rewarded by the drugmaker with lucrative consulting deals, according to the lawsuit.
Johnson & Johnson was negotiating a settlement with federal authorities over its aggressive marketing of Risperdal and Invega. The agreement originally stalled over language that the government wanted J&J to add acknowledging that it downplayed data on increased prolactin levels that stimulated breast development in children. Johnson & Johnson does not want to include that language because it fears the admission could be used in civil lawsuits. In 2013, the company finally agreed to pay $2.2 billion to settle the charges.
Hundreds of individual lawsuits have been 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 Aron Banks, who suffered breast development as a boy while taking Risperdal from 2000 to 2004. His successful case may be a bellwether for the hundreds of other lawsuits that allege breast growth from Risperdal or 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.