Invega (paliperidone) is a close descendant of Risperdal (risperidone), an antipsychotic drug designed to treat schizophrenia and other mental disorders. Risperdal received FDA approval in 1994, under a Johnson & Johnson/Janssen Pharmaceuticals patent that expired in 2003.
Invega can cause young boys to develop female breast tissue—a condition known as gynecomastia.
In anticipation of Risperdal’s patent expiration (and a slew of competing generic versions of the drug), Janssen developed Invega, which works in the same way as Risperdal.
Unfortunately, both Invega and Risperdal can cause young boys to develop female breast tissue—a condition known as gynecomastia. Janssen never strengthened Invega labels to warn of gynecomastia risks, which has led to numerous Invega (and Risperdal) lawsuits filed by patients who developed gynecomastia or similar side effects.
Hundreds of patients nationwide have filed lawsuits against J&J/Janssen, alleging that the company understood the gynecomastia risks but did not warn consumers adequately.
A Brief History of Invega
A few years after Janssen’s Risperdal patent expired in December 2003, the company released Invega—a near-identical drug—to soften the financial blow of competing against generic versions of Risperdal.
The FDA approved Invega for the treatment of schizophrenia in 2006. In 2009, the FDA expanded its approved uses to the treatment of schizoaffective disorder. That summer, the FDA also approved the long-acting, injectable form of Invega: Invega Sustenna.
In May 2015, the FDA approved an extended-release version of Invega called Invega Trinza. Trinza is a three-month, injectable, “suspension-suitable” form of Invega for patients who have taken Invega Sustenna for at least four months.
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 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).
J&J Illegally Marketed Invega, Other Drugs
Johnson & Johnson paid a large settlement to the federal government in 2013 for illegally marketing Invega and other drugs. The government says that J&J made false and misleading statements about the safety and effectiveness of Invega, and promoted it for off-label uses.
J&J engaged in similarly questionable practices with Risperdal, which it marketed to children prior to FDA approval for that use, and despite research showing the drug could cause gynecomastia.
Janssen wanted to widen its drugs’ appeals to maximize profits. For over a decade, the company engaged in deceptive and unlawful tactics, as covered in great detail by Steven Brill at The Huffington Post.
From 1999 to 2005, the FDA repeatedly warned J&J about promoting Risperdal for use by young people. During this time, the Justice Department says that Janssen promoted Risperdal for use in children and individuals with mental disabilities, despite knowing that Risperdal posed “certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development.” (In 2006, the FDA finally approved Risperdal for use by children and adolescents, specifically those suffering from autism.)
In 2012, Johnson & Johnson settled a Justice Department investigation into its promotion and marketing of Risperdal (and related state investigations, lawsuits, and probes) by paying a $2.2 billion fine, one of the largest in American pharmaceutical history.
But by then, the company had made nearly $30 billion (20 domestic, ten abroad) off the drug. Two billion dollars represented a tiny fraction of this profit—a slap on the wrist given all the kickbacks, unlawful marketing tactics, and data manipulation in which Johnson & Johnson engaged, to the detriment of consumers.
Hundreds if not thousands of boys have allegedly grown breasts from taking Risperdal and Invega.
Studies Link Invega to Gynecomastia
Gynecomastia stems from a hormone imbalance and can lead to the growth of male breasts and significant weight gain. It is believed that Invega may cause gynecomastia in young male users because it increases levels of the hormone prolactin, which stimulates female breast development and lactation.
Invega has also been linked to gynecomastia in at least two studies:
- 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 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 just two months after beginning treatment.
Risperdal (risperidone)—Invega’s predecessor, and a close relative (if not twin), chemically speaking—has been linked to an increased risk of gynecomastia in several studies.
This issue first gained attention in a 2006 study by a Duke psychiatrist that found a strong association between Risperdal and gynecomastia in children and adolescents. The study concluded that when risperidone is administered to adolescents for psychotic symptoms, the drug can increase prolactin levels and lead to gynecomastia.
Another 2006 study on risperidone and gynecomastia drew a similar conclusion, noting that risperidone should be administered to young patients with caution.
A more recent study published in the Journal of Child and Adolescent Psychopharmacology concludes that there is a strong association between risperidone use and gynecomastia in young adult males. Compared to non-users, children and adolescent risperidone users were found to have a gynecomastia risk that was five times higher. The study notes the “high psychological burden” of gynecomastia.
Traumatic Side Effects Spawn Thousands of Lawsuits
Many young men who have suffered severe and lasting injury from Invega or Risperdal have filed lawsuits against Johnson & Johnson seeking compensation for physical injury, medical bills, financial losses, and pain and suffering. While each case is different, lawsuits involving Invega usually seek compensation for some combination of the following:
- Mental anguish/pain and suffering*
- Current and future medical bills, including the cost of mastectomy
- Lost wages
- Punitive damages (an additional monetary award to the plaintiff to serve as punishment for the defendant)
- Attorney fees
*Reimbursement for pain and suffering covers the humiliation and psychological trauma associated with breast growth from taking Invega.
Juries Award Risperdal Plaintiffs Millions of Dollars
In November 2015, more than 1,500 Risperdal gynecomastia cases were consolidated as part of a mass tort in the Philadelphia Court of Common Pleas. All cases similarly allege that Risperdal caused gynecomastia in young men, and that Janssen did not warn users about this potential side effect.
Early Risperdal settlements indicate that Invega 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.
According to a Bloomberg News release, Janssen faces around 5,400 Risperdal cases nationwide (not all related to gynecomastia) and has set up a large reserve to settle lawsuits.
In addition to Invega and Risperdal, Johnson & Johnson faces massive lawsuits over its talc-based powders, which have been linked to an increased risk of ovarian cancer.
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