Invega Lawsuit

What is Invega?

Invega Sustenna (generic: paliperidone) is a second-generation antipsychotic drug that works by rebalancing dopamine and serotonin in the brain, which theoretically improves thinking, mood and behavior. The drug is approved to treat schizophrenia in adults and adolescents, as well as schizoaffective disorder. Invega is made by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), and was first approved by the U.S. Food & Drug Administration (FDA) in August 2009.

Invega and Risperdal

Invega is similar to Risperdal (generic: risperidone), another antipsychotic drug made by Janssen. Invega is the primary active metabolite in Risperdal, which means that both medications are broken down by the liver into similar chemicals. Both Invega and Risperdal work in a similar way and have similar side effects, but Invega is an oral, extended-release medication.

What’s the Problem?

Lawsuits have been filed against Janssen alleging that Invega may increase the risk of abnormal breast tissue growth in boys and young men, a condition known as gynecomastia. The complaints further allege that Janssen failed to adequately warn about this risk, misled the public and medical community about the safety of the drug, and hid information about gynecomastia to increase its profits.

How Can Invega Cause Gynecomastia?

Invega works by regulating levels of dopamine, a neurotransmitter in the brain that can cause hallucinations and abnormal thinking in excessive amounts. It is believed that this mechanism of action may cause the pituitary gland to release prolactin, a hormone that stimulates milk production in females and gynecomastia in men. A 2006 study published in the Journal of Clinical Psychopharmacology found that antipsychotic medications like Invega can cause excessive production of prolactin which could lead to gynecomastia in males.

Gynecomastia Symptoms

Swollen breast tissue
Pain
Tenderness
Discharge from one or both breasts

Treatment

Most cases of gynecomastia resolve over time without the need for treatment. However, if the condition is caused by an underlying condition (i.e. hypogonadism, malnutrition, cirrhosis) it may need surgery. If Invega is determined to be the likely cause of gynecomastia, the prescribing doctor will likely recommend discontinuing treatment in favor of another medication with fewer potential side effects.

Invega Side Effects

In addition to being linked to gynecomastia, Invega may also cause the following serious side effects in some users:

Diabetes, high blood sugar (hyperglycemia)
Bone loss (demineralization)
Sexual dysfunction
Pituitary tumors
Tardive dyskinesia
Weight gain
Neuroleptic malignant syndrome
Heart problems, heart attack, irregular heart rhythm
Suicide
Pancreatitis
Increased risk of death among elderly people with dementia

Federal Lawsuit Leads to $1.6 Billion Invega Settlement

In November 2013, Johnson & Johnson agreed to resolve criminal and civil investigations into the marketing of Invega, Risperdal and other medications by paying over $2.2 billion, one of the largest penalties ever levied against a company for healthcare fraud. Janssen pleaded guilty to misbranding Invega and Risperdal for “off-label” uses, and for paying kickbacks to doctors and to Omnicare Inc., the largest pharmacy for nursing homes.

Invega Timeline

Nov 2005 – Drug Application Submitted

Nov 30, 2005 – New Drug Application submitted for paliperidone.

Apr 2006 – Journal of Clinical Psychopharmacology study published

April 2006 – Study published in the Journal of Clinical Psychopharmacology finds that antipsychotic drugs like Invega can increase prolactin levels in men, increasing the risk of gynecomastia.

Sep 2006 – FDA issues letter

Sep 29, 2006 – FDA Issues approvable letter for paliperidone ER for the treatment of schizophrenia.

Nov 2006 – Janssen selects brand name

Nov 10, 2006 – Janssen selects Invega as the brand name for its investigational atypical antipsychotic.

Dec 2006 – Approved by the FDA

Dec 21, 2006 – Invega approved by the FDA as a new treatment for schizophrenia.

Apr 2007 – Approved for schizophrenia treatment

Apr 27, 2007 – FDA approves Invega for long-term maintenance treatment of schizophrenia.

Oct 2007 – Submission of New Drug Application announced

Oct 29, 2007 – Elan announces J&J submission of a New Drug Application to the FDA for paliperidone palmitate using Elan’s proprietary NanoCrystal technology.

Aug 2008 – FDA issues complete response letter

Aug 27, 2008 – FDA issues complete response letter for paliperidone palmitate for the treatment of schizophrenia.

Aug 2009 – Approved for schizoaffective disorder

Aug 6, 2009 – Invega approved as the first and only treatment for schizoaffective disorder.

Apr 2011 – Approved for adolescents

Apr 11, 2011 – Invega approved as treatment for schizophrenia in adolescents.

Nov 2013 – J&J agrees to resolve federal investigations

November 2013 – J&J agrees to resolve federal investigations into the illegal marketing of Invega and Risperdal by paying over $2.2 billion.

Feb 2009 – FDA filings announced

Feb 6, 2009 – Johnson & Johnson announces FDA filings for paliperidone palmitate and Invega.