Risperdal & Invega

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 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.

What are Risperdal and Invega?

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.

Litigation

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.

How Risperdal and Invega Work

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.

How Risperdal Works
How Risperdal Affects You

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.

Treating ADHD with Risperdal

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.

Reports of Side Effects

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.

Questions of Diagnosis

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.

Side Effects

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.

Risperdal is associated with serious side effects, including:

Breast Development in Boys

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.

Movement Disorders

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.

Diabetes

Both drugs are linked to Type 2 diabetes and high blood sugar.

Heart Problems and Death

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
Insomnia Sedation Akathisia (restlessness)
Vomiting Drooling Abdominal pain
Dizziness Nausea Anxiety
Tremor

Lawsuits

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 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.

Recalls and Settlements

Following the blockbuster success of Risperdal, the manufacturers of Risperdal now face a multibillion-dollar government settlement that covers illegal marketing charges, as well as similar settlements with the states totaling nearly $2 billion. The problems stem from the companies’ 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 hundreds more.

2011 Risperdal Recall

Two lots of Risperdal were recalled in 2011 because they were contaminated with chemicals used to treat shipment pallets.

2011 Invega Recall

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.

2013 Risperdal Recall

One lot of the injectable Risperdal Consta was recalled in 2013 because of mold concerns.

Vanessa Blanco

Patient Advocate vblanco@drugwatch.com
We want to hear from you.

If you or a loved one were affected by gynecomastia or any of the other dangerous side effects of Risperdal or Invega, our patient advocates can assist you.

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