Young boys who took Invega (generic: paliperidone) or received the Invega Sustenna injection and developed breasts.
Gynecomastia, abnormal breast tissue development in males, and hyperprolactinemia, abnormally high levels of prolactin (a hormone only found naturally in breastfeeding women) in the blood.
What is Invega?
Invega is used to treat schizophrenia in adults and adolescents ages 12 through 17. It has also been marketed for off-label uses including treatment of OCD, ADHD, and Tourette's syndrome.
Type of Lawsuit
Lawsuits have been filed against Janssen Pharmaceuticals alleging that Invega can increase a user’s risk of developing gynecomastia and/or hyperprolactinemia. These lawsuits accuse the company of releasing a defective drug into the marketplace and failing to provide adequate warnings for the dangerous side effects associated with Invega. Allegedly, Janssen knew that the drug could cause male users to produce higher-than-normal levels of prolactin (a hormone that stimulates milk production in women after childbirth), yet failed to warn patients about this risk.
Drug companies are required to fully and accurately disclose any and all side effects associated with their products, and may be held liable in court when they fail to do so.
What Are the Lawsuits Saying About Invega?
The lawsuits against Janssen allege that Invega is defective, and that the manufacturer misled doctors and patients about the safety and efficacy of the drug, and marketed it for off-label, unapproved uses. These suits have been filed on behalf of patients who, after using Invega, allegedly developed serious side effects including hyperprolactinemia, gynecomastia, rapid weight gain, diabetes mellitus, pancreatitis, metabolic syndrome, tardive dyskinesia (involuntary movements, usually of the face), and other adverse effects.
Specifically, the suits allege that:
Janssen knew safer, less expensive alternatives were available for schizophrenia patients, yet continued to market Invega as a safe and effective treatment.
Despite only having approval to prescribe Invega for adolescents, Janssen promoted use of the antipsychotic in children as young as three.
Janssen deliberately manipulated clinical trials, publications, and studies to suppress the public’s knowledge of negative side effects associated with Invega and to create a positive image for the drug.
How Does Invega Cause Gynecomastia and Hyperprolactinemia?
It is believed that Invega promotes pituitary gland secretion, which releases different hormones including prolactin, a hormone only found naturally in breastfeeding women. In turn, those who use these antipsychotic drugs may be at risk for developing hyperprolactinemia or abnormal breast tissue.
The active ingredient in Invega, paliperidone, is believed to be responsible for elevating prolactin levels in a way similar to that of Janssen’s other antipsychotic, Risperdal (risperidone). According to the current prescribing information for Invega, Risperdal users have reported significantly higher levels of prolactin in their blood, when compared to users of different antipsychotics. Risperdal users have also reported being diagnosed with gynecomastia and have sued Janssen for compensation.
Young Boy Developed Breasts Just Three Months After Using Invega
In 2012, the FDA performed a post-market adverse event review on Invega after the drug was approved for use in adolescents. According to the agency’s review, a 16-year-old boy developed breasts just three months after using Invega. Although follow-up information on treatment was unavailable in this case, many who develop gynecomastia only have one option for treatment: mastectomy.