Janssen Pharmaceuticals, a part of Johnson & Johnson, makes the antipsychotic drugs Risperdal and Invega. These are newer, second-generation antipsychotics, which are supposed to be safer and more effective than older versions of the drugs used to treat schizophrenia and other psychiatric conditions. Risperdal was first approved by the U.S. Food and Drug Administration (FDA) in 1993 and Invega, in 2006.

Since they came on the market, these drugs have made a lot of money for Johnson & Johnson, but litigation over the last few years has slowed sales. Unfortunately, these drugs come with some serious complications for some patients. From potentially permanent muscle disorders to breast enlargement in boys, Risperdal and Invega may cause serious side effects. Another problem is that the drug company is accused of marketing the drugs to young people without having approval from the FDA or communicating all of the risks.

What Are Risperdal and Invega?

Risperdal is the brand name for the generic drug called risperidone. It is an antipsychotic drug that was first studied in the 1980s, although it did not get approved by the FDA until 1993. It is considered an essential medicine by the World Health Organization for treating certain psychiatric disorders. Risperdal comes in two forms: a tablet taken orally and an injection, which lasts for two weeks.

Invega, also developed by Johnson & Johnson, is the generic drug paliperidone. Invega is an extended-release tablet form of the drug, which was approved by the FDA in 2006. Invega Sustenna is a long-acting injection. In 2015, an even longer-acting form of the drug, called Invega Trinza, was approved. It is injectable and lasts for three months.

Both Risperdal and Invega are approved to treat the symptoms of schizophrenia in adults and teens over the age of 13. Schizophrenia is a psychiatric disorder characterized by mood swings, disordered and disturbed thinking, and troubling behaviors. Risperdal can also be used to treat manic episodes of bipolar disorder. In children and teens on the autism spectrum, Risperdal may be used to treat aggression and mood swings.

Although it is not indicated or approved for use in children with attention deficit hyperactivity disorder (ADHD), more doctors are starting to prescribe Risperdal off-label for this reason. It seems to have some effectiveness in treating the symptoms of ADHD, including hyperactivity, impulsiveness, and inattention.

How These Drugs Work

In terms of their chemical structure and action, and how they work to treat certain conditions, Risperdal and Invega are very similar. In fact, Invega is a metabolite of Risperdal. That means that when the body breaks down Risperdal into smaller components, one of them is paliperidone, or Invega.

Both drugs are known as atypical antipsychotics because they target the neurotransmitter serotonin as well as dopamine. Other antipsychotics only target dopamine. Exactly why these drugs work to treat the symptoms of schizophrenia and other conditions is not fully understood, but they block serotonin and dopamine in the brain, and this seems to minimize aggression, disturbed thoughts, mania, and other symptoms.

Side Effects

Risperdal has the potential to cause a lot of side effects, although not everyone will experience them and they are usually not serious or long-lasting. Some of these are nausea, diarrhea, vomiting, constipation, heartburn, dry mouth, weight gain, anxiety, changes in sleeping patterns, dreaming more, dry skin, muscle and joint pain, missed menstrual periods, breast enlargement, and vision problems.

Invega causes fewer side effects. These include fatigue, dizziness, headaches, increased saliva production, weight gain, dry mouth, stomach pains, and weakness. For both of the medications these symptoms should not be severe and should decrease as the body gets used to the drug. If they do not go away or are severe, they should be reported to a doctor.

Gynecomastia

One of the more troubling potential side effects of Risperdal, especially for young boys taking it, is gynecomastia, or breast enlargement. The medication causes the body to produce more prolactin, which is the hormone that stimulates milk production in pregnant women and new mothers. This may also be what causes breast growth in boys taking Risperdal. There are no serious health concerns with gynecomastia, but it can be psychologically damaging.

Death in Elderly Dementia Patients

Risperdal and Invega both carry black box warnings on their informational inserts and product labeling. This is a warning box required by the FDA and reserved for the most serious and potentially life-threatening side effects of a medication. The FDA required that this warning be added in 2006 when the organization announced the finding that Risperdal and Invega had the potential to increase the risk of death in elderly patients with dementia.

Seventeen different trials were analyzed by the FDA to come to this conclusion. With over 5,000 participants, the studies showed that among elderly patients with signs of dementia, the risk of dying was 1.6 to 1.7 times greater in those taking Risperdal, Invega, or other atypical antipsychotics.

Recalls

In addition to the many possible side effects, and the few serious consequences that are possible, Risperdal and Invega have faced other challenges. In 2011, two lots of Risperdal were recalled because of contamination with a chemical. In the same year thousands of syringes with doses of Invega Sustenna were recalled because of cracks that could have caused contamination or led to infections. In 2013, more Risperall was recalled because of issues with mold.

Lawsuits

Johnson & Johnson’s Janssen Pharmaceuticals has faced numerous lawsuits because of some of the consequences of taking Risperdal. These have largely focused on gynecomastia in young boys, many of whom suffered psychologically from having larger breasts, and may have needed surgery to reverse the growth.

The lawsuits have also focused on the claim that the drug company promoted Risperdal and Invega for off-label uses. Doctors may prescribe drugs for off-label use, but drug companies are not supposed to promote their products for anything other than the indications approved by the FDA. Plaintiffs claim that Janssen promoted these drugs for use in children and adolescents before the FDA gave them the go-ahead to do so.

In the future, there may be more lawsuits over the use of Risperdal in children with ADHD. This is an off-label use and there is little real evidence to prove that it can be effective in treating ADHD symptoms, while the possible side effects are well known. ADHD is especially tricky because it is often misdiagnosed, so young people may be given an antipsychotic who don’t even have the condition is supposed to treat.

If you or a young person in your care has been negatively affected by Risperdal or Invega, you may be able to seek compensation through a lawsuit. Johnson & Johnson and Janssen Pharmaceuticals may be found to have been guilty of marketing drugs off-label, not adequately communicating risks, or promoting drugs known to have serious consequences, and if they are, you could benefit from monetary damages.