Invega (paliperidone)—like its predecessor, Risperdal—is made by Johnson & Johnson subsidiary Janssen Pharmaceuticals, Inc. J&J developed Invega to replace Risperdal because the patent protection on Risperdal expired in 2003.
Invega can cause young boys to develop breasts, a condition known as gynecomastia.
Unfortunately, both drugs have been linked to severe side effects and have generated thousands of lawsuits.
Risperdal and Invega are almost identical chemically and produce similar side effects. One potential side effect is the development of breast tissue in young boys, a condition known as gynecomastia which can result in serious psychological trauma and the need to undergo corrective surgery.
Several Risperdal lawsuits have been settled for millions of dollars. Given that precedent, Invega lawsuits could also result in significant compensation for plaintiffs.
How Invega Works
Like most antipsychotic medications, Invega works by regulating the body’s natural hormones. It has three forms:
- A once-daily oral tablet
- An extended-release injectable formulation (Invega Sustenna)
- A newer extended-release injectable form (Invega Trinza)
Paliperidone (Invega) and risperidone (Risperdal) have similar chemical structures and, unfortunately, similar side effects. Paliperidone is the primary active metabolite of risperidone. In other words, when Risperdal is broken down by the body into its active chemical ingredients, one of those ingredients is paliperidone.
Risperdal and Invega adjust hormones in the body like dopamine and serotonin, regulating patients’ moods. Research has shown, however, that these hormone changes—specifically, increases in the hormone prolactin, which stimulates breast development and milk production in women—can also lead to unwanted side effects such as the growth of breast tissue in men (gynecomastia).
Research Links Invega to Gynecomastia
Much of the research that shows a link between these drugs and gynecomastia focuses on Risperdal, including studies published in the Journal of Child and Adolescent Psychopharmacology, Pharmacotherapy, and the Journal of Clinical Psychopharmacology. Because Risperdal and Invega act via the same pathways in the body, this research has strong implications for both paliperidone and risperidone.
Other studies directly link Invega to gynecomastia:
- Research presented at the American Association for Geriatric Psychiatry (AAGP) Annual Meeting in 2014 showed that men who used risperidone or paliperidone had a 69% higher risk of developing gynecomastia than nonusers.
- An FDA review of serious pediatric Invega side effects found that 3% of patients taking a 12 mg. daily dose of paliperidone developed gynecomastia, including a 16-year-old boy who experienced symptoms only a couple of months after beginning treatment.
J&J Fined $2 Billion for Off-Label Promotion of Invega
Invega gained U.S. Food and Drug Administration (FDA) approval for adult schizophrenia treatment in 2006. In 2011, it was approved for adolescent schizophrenia treatment.
But doctors also prescribe Invega for off-label uses such as depression, obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), and personality disorders. Doctors may legally prescribe drugs off-label, but it is illegal for pharmaceutical companies to promote off-label drug uses.
In 2013, the federal government hit Johnson & Johnson with one of the largest pharmaceutical fraud settlements in history over J&J’s off-label marketing and kickback schemes. The Department of Justice claims that, from 2006 to 2009, J&J/Janssen marketed Invega “for off-label indications and made false and misleading statements about its safety and efficacy.”
J&J faced similar accusations over Risperdal, which it promoted to children before it was legally allowed to do so, and despite knowing that Risperdal could gynecomastia in young patients. J&J contacted doctors to persuade them to prescribe Risperdal to children for off-label uses, and offered toys and candy in Risperdal samples.
Invega lawsuits accusing Johnson & Johnson/Janssen of negligence and fraud have been filed nationwide. Plaintiffs similarly allege that their use of J&J’s antipsychotic drugs caused them to develop unnatural breast tissue, including one young man who says that his Risperdal use as a teen resulted in him growing size 44D breasts.
Close to 1,600 Risperdal lawsuits (part of a mass tort) are pending in the Philadelphia Court of Common Pleas. Some of these cases involve patients who took Risperdal and/or Invega. A mass tort is different than a class action lawsuit. Invega plaintiffs maintain their own separate lawsuit, attorney, and trial.
The main charge against Janssen is that it failed to properly warn about Invega/Risperdal side effects. Gynecomastia is listed as a possible side effect of Invega—but not until page 20 of a 50-page prescribing booklet. Invega packaging provides no warning about gynecomastia.
Janssen maintains that the risk of gynecomastia from Invega/Risperdal is very low, but there is strong evidence that (in the case of Risperdal) Janssen manipulated data to make the gynecomastia risk appear lower than it actually is. A former FDA official testified during a Risperdal lawsuit that J&J knew as early as 2001 that Risperdal could cause gynecomastia, yet the company did not add this information to product labeling until 2006.
It is not yet known whether Janssen similarly changed Invega data to downplay gynecomastia risks.
There have not been any reported Invega lawsuit settlements, but Risperdal settlements indicate that gynecomastia victims may be in line for significant compensation:
- In April 2015, a jury awarded a young man who developed size 44D breasts from taking Risperdal $2.5 million in damages. The jury found that Janssen failed to properly warn about the ability of Risperdal to cause gynecomastia.
- In November 2015, a jury awarded $1.75 million to a man who began taking Risperdal in 2003 for schizophrenia, who also developed gynecomastia.
- In July 2016, a jury awarded Tennessee man Andrew Yount $70 million in damages. Mr. Yount developed breasts after taking Risperdal as a five-year-old.
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