Invega Pharmaceuticals has been accused of false advertising in a lawsuit brought by the FDA over their drug for gynecomastia, which was also marketed as an anti-aging treatment. The company claimed that Gynexin had success rates “up to 90%” when results were actually only up to 60%.
The FDA is seeking $31 million from Invega and other defendants, while they are on track with legal proceedings.
In the meantime, Robert Sargenti says he has found US$575 million worth of gold stashed in New York City’s trucking industry after his firm was kicked off a case due to fraud allegations.
Invega is a weight loss supplement that has been the subject of lawsuits. One such lawsuit is the “invega weight gain lawsuit.” The plaintiff in this case was a man who experienced gynecomastia and male breasts after taking Invega.
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 has been linked to the development of breasts in young males, a disease known as gynecomastia.
Unfortunately, both medications have been associated to serious adverse effects, and hundreds of lawsuits have been filed as a result.
Risperdal and Invega are chemically nearly identical and have comparable negative effects. One possible adverse effect is the growth of breast tissue in young males, a condition known as gynecomastia, which may cause severe psychological anguish and need surgery to address.
Several cases involving Risperdal have been settled for millions of dollars. Invega litigation might result in large compensation for plaintiffs based on this precedent.
Invega, like other antipsychotics, works by balancing the body’s natural hormones. It comes in three varieties:
- Oral pill should be taken once a day
- An injectable formulation with a longer release time (Invega Sustenna)
- A newer injectable version with a longer duration of action (Invega Trinza)
Paliperidone (Invega) and risperidone (Risperdal) have chemical structures that are quite similar and, regrettably, have very comparable adverse effects. Risperidone’s main active metabolite is paliperidone. In other words, when the body breaks down Risperdal into its active chemical constituents, paliperidone is one among them.
Risperdal and Invega regulate patients’ emotions by adjusting hormones in the body such as dopamine and serotonin. However, research has revealed that same hormone changes—specifically, increases in the hormone prolactin, which encourages breast development and milk production in women—can also cause undesirable side effects in males, such as breast tissue growth (gynecomastia).
Invega has been linked to gynecomastia in studies.
Risperdal is the subject of most of the research linking these medicines to gynecomastia, including papers published in the Journal of Child and Adolescent Psychopharmacology, Pharmacotherapy, and the Journal of Clinical Psychopharmacology. This finding has substantial implications for both paliperidone and risperidone since Risperdal and Invega function through the same pathways in the body.
Other investigations have shown a direct relationship between Invega and gynecomastia:
- Men who took risperidone or paliperidone had a 69 percent greater chance of developing gynecomastia than nonusers, according to research presented at the American Association for Geriatric Psychiatry (AAGP) Annual Meeting in 2014.
- According to an FDA study of significant pediatric Invega side effects, 3% of patients receiving a daily dosage of paliperidone of 12 mg developed gynecomastia, including a 16-year-old male who developed signs only a few months after starting therapy.
J&J Fined $2 Billion for Off-Label Promotion of Invega
Invega was approved by the US Food and Drug Administration (FDA) in 2006 for the treatment of adult schizophrenia. It was authorized for the treatment of teenage schizophrenia in 2011.
Off-label applications of Invega include depression, obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), and personality problems, among others. Off-label prescribing is lawful for doctors, but it is prohibited for pharmaceutical corporations to encourage off-label prescription use.
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.
Lawsuits by Invega
Lawsuits by Invega 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.
In the Philadelphia Court of Common Pleas, about 1,600 Risperdal cases (as part of a mass tort) are underway. Patients on Risperdal and/or Invega are involved in several of these incidents. A mass tort is not the same as a class action suit. Plaintiffs in the Invega case have their own lawsuit, counsel, and trial.
The major claim leveled against Janssen is that it failed to adequately warn about the risks of Invega/Risperdal. Invega’s potential side effect of gynecomastia is stated on page 20 of a 50-page prescription handbook. Gynecomastia is not mentioned on the package of Invega.
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’s unclear if Janssen altered Invega statistics to minimize the risk of gynecomastia.
Although no Invega lawsuit settlements have been disclosed, Risperdal settlements suggest that gynecomastia sufferers may be eligible for large compensation:
- In April 2015, a jury awarded $2.5 million in damages to a young man who got size 44D breasts after taking Risperdal. Janssen failed to adequately warn about Risperdal’s tendency to induce gynecomastia, according to the verdict.
- In November 2015, a jury awarded $1.75 million to a man who acquired gynecomastia while using Risperdal for schizophrenia in 2003.
- Andrew Yount of Tennessee was awarded $70 million in damages by a jury in July 2016. After using Risperdal as a child, Mr. Yount grew breasts.
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The “medication lawsuit list” is a list of lawsuits that have been filed against the pharmaceutical companies for their products. The list includes cases about gynecomastia and male breasts.
Frequently Asked Questions
Can INVEGA cause gynecomastia?
A: In general, no. There is a rare chance that INVEGA could cause gynecomastia as it has been reported to do so in some patients, but the risk of this compounding with male breast cancer is already significant enough without also adding treatment for gynecomastia to the list of risks.
Can INVEGA cause tumors?
A: INVEGA is not known to cause tumors.
Does INVEGA cause permanent damage?
A: INVEGA is a medication that has been shown to be safe and effective in the treatment of narcolepsy.
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