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Risperdal and Invega Side Effects

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Risperdal, Risperidone and Invega are linked to a number of serious side effects, including diabetes, development of breasts in males (gynecomastia) and movement disorders.

Risperdal (risperidone) and Invega (paliperidone) are antipsychotic medications sold by Johnson & Johnson and approved by the U.S. Food and Drug Administration (FDA) to treat schizophrenia. Eventually, the FDA approved Risperdal for additional uses, including bipolar disorder and autism. It is also used to treat attention deficit hyperactivity disorder (ADHD), anxiety, insomnia and depression. Invega is also approved to treat schizoaffective disorder.

However, these two drugs can cause serious side effects such as breast development in boys. Hundreds of boys who took these drugs suffered breast tissue enlargement, and some were forced to have surgery to remove the tissue.

They can also cause movement disorders, diabetes and even death. As a result of these side effects, a number of patients and their families filed lawsuits against Johnson & Johnson.

Serious Side Effects

People who take Risperdal, Risperidone or Invega may suffer from a number of side effects, including serious ones like gynecomastia, movement disorders, diabetes, pituitary tumors and heart problems that can lead to death.

Gynecomastia

Gynecomastia is a condition characterized by abnormally large breasts in males. It is caused by excessive breast tissue growth, not excess fat. The condition is often caused by hormone imbalances in the body. In the case of Risperdal and Invega, the problems stem from an overabundance of the hormone prolactin.

Prolactin controls sex drive in males and sustains lactation (breast-feeding) in females and is produced by the pituitary gland. Risperdal and Invega work by blocking dopamine receptors, and dopamine controls the levels of prolactin. Because the drugs block dopamine’s action on the pituitary gland, the levels of prolactin increase and can reach abnormal levels – a condition known as hyperprolactinemia.

Hyperprolactinemia occurs more often with Risperdal than other antipsychotics. In fact, according to data from the New Zealand Medicines and Medical Devices Safety Authority, more than 90 percent of those taking the drug have elevated levels of prolactin. In children and adolescents, the overabundance of prolactin can cause gynecomastia; milky, nipple discharge in both males and females (galactorrhea); the absence of periods in females; and delay in growth and maturation. Because Invega is a derivative of Risperdal, it can have the same effect on hormones.

In clinical trials involving 1,885 children and adolescents taking Risperdal, 43 boys experienced gynecomastia. Since the FDA approved the drug for use in children, hundreds of boys have developed breasts while on the medication — including in some cases breasts as large as “D” cups, according to Forbes.

Hundreds of boys and young men filed gynecomastia personal injury lawsuits against Johnson & Johnson and its Janssen unit, claiming the drugmaker failed to adequately warn patients.

Pituitary Tumors

Because Risperdal and Invega cause the pituitary gland to produce more prolactin, it may also cause the gland to grow in size. This disrupts the production of other hormones and can lead to the development of pituitary tumors.

One study published in the journal Pharmacotherapy analyzed the FDA’s adverse effect database and found that Risperdal accounted for 70 percent of all pituitary tumors. The researchers also say that there may be more cases but the adverse events are underreported.

While pituitary tumors are usually benign, they can cause other serious health problems such as vision problems, internal bleeding, headaches and even convulsions.

Movement Disorders

Risperdal and Invega also increase the risk of movement disorders such as extrapyramidal symptoms or EPS (loss of control over movement) and tardive dyskinesia (involuntary, repetitive movements).

While most antipsychotic drugs come with a higher risk of these disorders, atypical antipsychotics like Risperdal and Invega cause even more cases of EPS and tardive dyskinesia.

If a patient notices any loss of motion or control while taking these drugs, a doctor needs to address the problem before it becomes irreversible. Although addressing EPS and tardive dyskinesia often involves stopping treatment with antipsychotics, some patients may require continuation of Risperdal therapy despite the presence of movement disorders.

Diabetes

Patients with schizophrenia are already at an increased risk of diabetes mellitus (type 2 diabetes) compared with the general population. On top of this, studies suggest a relationship between antipsychotic use and hyperglycemia-related events (high blood sugar incidents). Patients on any antipsychotic should monitor their glucose levels.

Risperdal and Invega are associated with elevated blood sugar levels and diagnoses of type 2 diabetes, including, in rare cases, extreme ketoacidosis (shortage of insulin) resulting in coma or death. Studies suggest that the risk of type 2 diabetes is higher with atypical antipsychotics than with traditional antipsychotics.

Heart Problems and Death

Risperdal and Invega carry a black-box warning about the risk of death in elderly patients with dementia-related psychosis; these drugs are not recommended for these patients.

All antipsychotics are associated with the risk of sudden cardiac death due to an arrhythmia (irregular heartbeat). Invega can lead to a rapid heart rate, as well. Another rare but serious side effect is neuroleptic malignant syndrome (NMS), a life-threatening neurological condition that occurs in less than 1 percent of patients taking an antipsychotic medication.

Other Side Effects

Weight gain is one of the most common side effects of Risperdal and Invega. In one study, Risperdal patients gained an average of 4.6 pounds after 10 weeks of treatment. The FDA reports that patients on Risperdal had “a statistically significantly greater incidence of weight gain.”

Weight gain is problematic for several reasons. Aside from the health risks of obesity, weight gain is a primary reason that patients stop taking their medication, which often results in a relapse of their condition. Weight gain can also lead to diabetes.

Risperdal and Invega have also been linked to the following side effects, according to the FDA:

  • Abdominal pain
  • Akathisia (restlessness)
  • Anxiety
  • Dizziness
  • Drooling
  • Fatigue
  • Insomnia
  • Nausea
  • Priapism (prolonged penile erection)
  • Sedation
  • Somnolence
  • Tremor
  • Vomiting

Patients who experience any side effects while taking Risperdal or Invega should contact their doctor. They should not stop taking these drugs without consulting with a doctor, as this may result in withdrawal and a relapse of symptoms

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