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Paliperidone is one of the primary active metabolites that can be found in the antipsychotic treatment risperidone (also known as Risperdal). Although extensive research has yet to define what the specific mechanism of action, or the biochemical interaction of the drug substance, of the paliperidone drug is, scientists do believe that its effects are nearly identical to that of the risperidone drug. Invega was the original name given to the paliperidone drug and was approved by the Food and Drug Administration (FDA) in 2006 as another option for schizophrenia treatments as well as bipolar mania. In 2009, the FDA also approved its usage to specifically treat schizoaffective disorder.

All of these above conditions relate to specific social and emotional behavior disorders, and paliperidone was established as a means of treating these conditions. It is also very common that doctors will use this prescription as an off-label, similar to risperidone, to treat other conditions such as Asperger syndrome or autism.

Invega Sustenna is the injectable form of paliperidone treatment and was approved by the FDA in 2009 as a long-acting injectable form of the prescription. In the U.S. the patient is given a monthly dosage every 28 days by their physician in the form of injection with 75 mg, which has the equivalent of taking paliperidone orally every day in 6 mg dosages. The oral Invega dosage of 6 mg compares to a risperidone prescription a patient would take daily of 2 or 3 mg. When a patient is given Invega Sustenna, it is injected deep into the muscle tissue.

As one of the first firms to try a Risperdal case in the multidistrict litigation in Philadelphia, our attorneys knew we would set the standard for litigation coming after us. We responded as we usually do—with incredible results and genuine passion for our client’s well-being. We secured a $76.6 million verdict, the largest Risperdal verdict to date. Our result was more than 20 times bigger than the previous 4 verdicts combined.

We are proud to have helped our client receive justice, closure, and medical treatment. Contact us today to discuss your case.

Prolactin in Invega Sustenna

The hormone prolactin is an active ingredient in all risperidone medications. This is the hormone that causes women to produce milk during pregnancy and also causes women to grow breasts during puberty. When prolactin is injected into the body in Invega Sustenna, it can encourage breast growth in both males and females. In male patients, this is a condition called gynecomastia.

Those with this condition will develop large breasts and may even lactate as a result. Some men have required breast reduction surgery or a mastectomy to remove the unwanted growths on their body. This serious symptom of risperidone medications like Invega Sustenna can be emotionally and psychologically damaging as well. Males who are forced to undergo the embarrassment of breast growth often fall into unstable psychological conditions as a result. The shame of the situation, as well as the discomfort and pain of a mastectomy, can be astronomical.

Warnings & Side Effects of Invega Sustenna

Doctors have compared Invega Sustenna to having similar, if not identical, effects as risperidone.

As a result, patients are cautioned with many possible side effects associated with this form of behavior and mood treatment medication. While there are warnings today about the possibility of specific side effects, many male victims have suffered severely by taking these treatments without receiving the knowledge of particular concern regarding the prolactin hormone that is effected in the body. One of the biggest concerns with both paliperidone and risperidone is the fact that due to the significantly increased prolactin levels, particularly in male patients of all age, they may experience unwanted breast tissue growth and breast milk, among many other possible health concerns.

According to the Invega Sustenna website, some of the side effects of the medication include missing menstrual periods, lactating from the breasts, and the development of breasts in men. Currently, a popular risperidone medication called Risperdal is the subject of various lawsuits because of arguments about the labeling of the drug. Many men who have suffered from gynecomastia say that they could have been spared the embarrassment and shame of their situation if the packets of Risperdal had clearer warnings about the breast growth side effect.

Common side effects of this drug may include, but are not limited to:

  • Gynecomastia and galactorrhea;
  • Drowsiness, lightheadedness, dizziness, weight gain;
  • Muscle spasms, restlessness, fever, sore throat, irregular heartbeat, seizures;
  • Uncontrollable muscle movements in the face, lips, tongue, mouth, arms or legs (tardive dyskinesia condition)
  • Neuroleptic malignant syndrome

Invega Sustenna FAQ

Does Invega Cause Gynecomastia?

Invega Sustenna's main active ingredient is paliperidone, a close 'relative' of risperdone. Both chemicals cause an increase in the hormone "prolactin," which stimulates both breast development and milk production. Due to its closeness to risperdone, Invega Sustenna has been linked gynecomastia, or the abnormal growth of breast tissue in young boys.

Is Gynecomastia Reversible?

In cases where gynecomastia has been caused by Invega usage, some cases may improve through exercise and diet. However, in many cases the abnormal breast tissue will remain, even if the patient stops taking Invega Sustenna. When tissue growth is permanent, only surgery will be able to undo the damage caused by paliperidone. Unfortunately, because gynecomastia is not life-threatening, most health insurances will not cover corrective surgery—even when gynecomastia causes severe emotional and social trauma.

Who Does Invega-Related Gynecomastia Affect?

A study in 2014 revealed that older men who took paliperidone or risperdone were 69% more likely to develop gynecomastia than nonusers. However, it's boys who have taken paliperidone or risperdone during childhood who have experienced the most painful effects of gynecomastia. As young men are developing, abnormal breast growth tends to occur as they're reaching puberty, which generates a create deal of shame and embarassment.

Representation from Invega Attorneys. Call (888) 493-1629 Today.

If you are suffering from gynecomastia because you took Invega Sustenna or another risperidone medication with the prolactin hormone, then you may have the right to seek compensation from the drugmaker. Invega Sustenna is a Janssen medication by Johnson & Johnson, the same company that also manufactures Risperdal. All pharmaceutical companies are required to post the side effects of their medicine blatantly on the packaging so that it will serve as a warning to individuals that are receiving injections.

If a company is not clear in their labeling or circumvents the FDA's oversight, you may be able to seek compensation. Talk to Arnold & Itkin today at (888) 493-1629.

Case Results

Check Out Our Victories

  • $8 Billion Top 3 Largest Jury Verdict in U.S. History Arnold & Itkin LLP tried a Risperdal case against Johnson & Johnson for failing to warn about one of the drug’s most damaging side effects: gynecomastia. Our skill, hard work, and dedication resulted in the third-largest jury verdict ever obtained ...
  • $357 Million Largest Workplace Accident Settlement in Texas history Arnold & Itkin LLP secured a massive nine-figure settlement against a transnational corporation for a workplace incident. The settlement set a Texas record for being the largest personal injury settlement in the state’s history.
  • $205 Million Confidential Settlement Obtained for Numerous Clients Arnold & Itkin reached a record $205,000,000 settlement on behalf of clients after several years of hard-fought litigation. The case settled just before trial was set to begin.
  • $171 Million One of the Largest Confidential Settlements in History Arnold & Itkin worked over the course of several years to represent clients in a case that many other law firms turned down. In the end, we were able to obtain a record-setting confidential settlement of $171 million.
  • $117 Million Largest Single-Event Personal Injury Verdict in Louisiana History Arnold & Itkin represented a pregnant woman who experienced stomach pain and called Acadian Ambulance. The driver of the ambulance drove the ambulance into the back of a sugar cane truck causing the plaintiff's spine to be severed at T4 and for her ...
  • $116 Million Confidential Settlement Arnold & Itkin LLP negotiated a massive nine figure settlement on behalf of their clients after several years of hard fought litigation.
  • $110 Million Record Settlement Achieved for Victims of Defective Products Arnold & Itkin obtained a record settlement for individuals harmed by defective, dangerous products. The result exemplifies our commitment to clients and justice for those seriously injured by the conduct of others.
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  • $97 Million Massive Settlement Secured for Refinery Workers Arnold & Itkin is proud to share that after months of preparation for trial, our firm was able to secure a huge settlement for clients who were injured in a refinery fire. Find out more now.
  • $92.7 Million Record Settlement for Burn Injury Victim Arnold & Itkin LLP secured a substantial settlement for a man who suffered severe burns in an accident at his job. The settlement set a new record statewide for workers with similar injuries.
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