According to the U.S. Food and Drug Administration (FDA), elderly dementia patients who have taken the antipsychotic drug paliperidone, which is sold under the brand name Invega and is the “active metabolite” of a similar Risperdal (risperidone)—are 1.6-to-1.7 times more likely to die of various ailments, including heart disease and pneumonia. Medical research has also found a connection between Invega and adolescent male breast enlargement (gynecomastia). If you or a loved one has taken Invega, and you believe it contributed to heart disease, pneumonia, male breast growth, or some other negative side effect, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group knows this, and we want you to believe it. We might be the Invega law firm you are looking for.
What Is Invega and What Is It Prescribed For?
Invega is the brand name for the drug paliperidone. Made and sold by Johnson & Johnson (J&J) subsidiary Janssen Pharmaceuticals, this prescription medication is used to treat schizophrenia and schizoaffective disorders in teenagers and adults. The FDA approved the drug in 2006, and doctors can prescribe it in extended-release tablets and as an injectable (Invega Sustenna).
According to the drug’s label, Invega is the “major active metabolite” of risperidone, another antipsychotic drug. However, Invega’s specific mechanism of action is not well understood, though this is not uncommon for drugs designed to treat schizophrenia. Medical experts speculate that Invega blocks dopamine Type 2 receptors and serotonin Type 2 receptors in the brain. It’s less likely than some antipsychotic drugs to cause involuntary body movements at low doses.
To date the only Invega recall that occurred happened in February 2011 not due to an adverse side effect but because J&J discovered cracks in 70,000 Invega Sustenna syringes. It was feared that the cracks would compromise the syringes sterility, but no users reported any adverse side effects.
Invega Might Cause Life-Threatening Side Effects in the Elderly
The FDA does not approve Invega for the treatment of dementia in the elderly, and it requires a black box Invega warning on the product’s label informing users that the drug carries an increased risk of death in elderly users. The FDA determined that elderly people with dementia who used Invega were 1.6-to-1.7 times more likely to die of various ailments, including heart disease and pneumonia.
Invega Might Cause Neuroleptic Malignant Syndrome and Tardive Dyskinesia
Invega’s drug label states that the drug might cause of Neuroleptic Malignant Syndrome (NMS). NMS is a potentially fatal disorder with the following symptoms:
- Muscle rigidity;
- Altered mental status; and
- Autonomic instability (irregular heartbeat or blood pressure, excessive sweating).
Invega is also a potential cause of Tardive Dyskinesia, a potentially irreversible condition characterized by involuntary facial movements such as:
- Puckering and pursing of the lips;
- Tongue protrusion;
- Lip smacking; and
- Rapid eye blinking.
Invega Might Cause Male Breast Growth
When it was first approved, Invega was not indicated for treating adolescents, but some doctors nonetheless prescribed it to boys, some of whom developed gynecomastia (male breast growth). Many doctors simply attributed the breasts to weight gain and not a unique side effect of the drug. In April 2013, the medical journal Plastic and Reconstructive Surgery published an article finding that gynecomastia has “a significant negative impact on primarily the psychosocial well-being of affected adolescent patients, specifically in regard to social functioning, mental health, and self-esteem.” In August 2012, J&J settled Risperdal and Invega breast growth lawsuits in 36 states for a total of $181 million.
Invega Might Cause Other Harmful Side Effects
Like many antipsychotics, Invega carries a suicide warning in its “Warnings and Precautions” section.
The “Pregnancy” section of Invega’s label informs doctors and women who are about to become pregnant that Invega causes withdrawal symptoms in infants in the form of abnormal muscle movements (called extrapyramidal signs (EPS)). Symptoms of EPS include:
- Hypertonia (excessive muscle rigidity);
- Hypotonia (excessive muscle elasticity);
- Somnolence (sleep disturbances);
- Respiratory distress; and
- Feeding disorder.
Most EPS withdrawal symptoms pass after a few days.
In another recent change to Invega’s label, it is now apparent that the drug might also cause hyperglycemia (excess sugar) and diabetes. Atypical antipsychotics cause the body to metabolize fat instead of carbohydrates, leading to insulin resistance to the excess carbohydrates. At the same time they promote fat accumulation.
RLG’s Invega Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Invega lawsuit on your behalf if necessary. RLG will also keep you up to date on any Invega class action lawsuits, FDA Invega warnings, and Invega FDA recall announcements. If you or a loved one has taken Invega, and you believe it caused an injury, contact RLG today.