In November 2013, Johnson & Johnson paid $2.2 billion to the Justice Department for illegally marketing Invega in children and making false statements about its safety.
What is Invega?
Invega Sustenna is the brand name of paliperidone, an anti-psychotic drug that is used to treat schizophrenia and schizoaffective disorder. It was developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and approved by the FDA in 2006.
Invega and Risperdal
Invega is very similar to Risperdal (risperidone), another anti-psychotic drug manufactured by Janssen and J&J. Invega is the primary active metabolite of Risperdal, which means both drugs are broken down by the liver into similar chemicals. Both Invega and Risperdal work in a similar way and have similar side effects — including gynecomastia — but Invega is an oral, extended-release medication.
Invega and Gynecomastia
Invega treats psychiatric disorders by changing brain chemistry, which can also cause hormonal imbalances. In some cases, levels of a pregnancy hormone called prolactin increase dramatically, leading to a condition called “hyperprolactinemia.” In young men, prolactin can cause gynecomastia, or the growth of glandular male breast tissue.
Gynecomastia from Invega is not life-threatening, but the condition is physically disfiguring and emotionally embarrassing — especially for young boys and teenagers, who are vulnerable to teasing from their peers and long-term psychosocial trauma. For this reason, most doctors recommend surgery and/or liposuction to correct gynecomastia.
$2.2 Billion Invega Lawsuit Settlement
In November 2013, the U.S. Department of Justice (DOJ) ordered Janssen and J&J to pay $2.2 billion for using illegal marketing tactics to promote Invega and two other drugs. The judgement includes $1.39 billion for illegal “off-label” marketing of the drugs in children. Prosecutors stated:
“Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.”
Risks & Complications of Invega
- Male breast enlargement (gynecomastia)
- Involuntary movement disorders
- Tardive dyskinesia
- Medically serious weight gain
- Type-2 diabetes
- Neuroleptic Malignant Syndrome
- Strokes and cardiovascular events in elderly dementia patients
- Abnormal heart rhythm (QT prolongation)
- And more