Risperdal

Risperdal (risperidone) is an antipsychotic medication, approved to treat schizophrenia, bipolar disorder symptoms of autism which is used in children and adults. It has also been used in a number of unapproved conditions and caused serious side effects in some patients including breast tissue development in children and increased death risk in the elderly.

Quick Summary
Risperdal

Risperdal (risperidone) is an antipsychotic drug manufactured by Janssen, a subsidiary of Johnson & Johnson. It was approved in 1994 to treat schizophrenia in adults and use has been expanded to treatment of schizophrenia in children, autism aggression in children, and bipolar disorder in children and adults.

Like most other antipsychotics, Risperdal works by decreasing activity of dopamine in the brain but also affects another neurotransmitter, serotonin which increases its effectiveness at treating bipolar disorder and other conditions.

Risperdal Side Effects

Like all medications, Risperdal, may cause a number of side effects. Most side effects are mild-to-moderate and will go away with time.

Common side effects include:

  • Fatigue, Sedation, Dizziness, Increased risk of falls
  • Restlessness, Anxiety, Tremor
  • Drooling, Tongue stiffness, Difficulty swallowing
  • Prolonged erection of the penis (priapism)
  • Nausea, Vomiting

Risperdal may also cause severe and life-threatening reactions in both children and adults such as:

  • Movement Disorders
    • Tardive Dyskinesia (abnormal movements of face, shoulders, and limbs)
    • Akathesia (physical restlessness)
    • Akinesia (inability to move)
    • Parkinson’s disease type tremor
  • Death in the Elderly –  The FDA has required a Black Box warning regarding use in the elderly due to a link to mortality in elderly dementia patients.
Risperdal and Gynecomastia

Risperdal has been shown to cause gynecomastia or development of breast tissue in males, due to a stimulation of the pituitary gland, resulting in increased levels of prolactin, a hormone common in pregnant and nursing women.

The development of gynecomastia has occurred in boys as young as age 4. It is particularly disturbing in adolescents and children as in addition to the physical changes which are permanent and must be removed through surgery, boys will often suffer significant emotional and mental trauma.

Risperdal has caused premature breast development and lactation (producing milk) in preadolescent girls. In some cases, lactation has also occurred in boys who have developed gynecomastia and in women who are not pregnant or nursing.

Risperdal is the brand name for the generic medication, risperidone which was first approved by the U.S. Food and Drug Administration (FDA) in 1994. It is used to treat schizophrenia, bipolar disorder and behavioral symptoms of autism and was once the best-selling antipsychotic on the market. It works by blocking neurotransmitters like dopamine and serotonin, chemical messengers in the brain.

Risperdal is manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. It was a “next generation” drug that was intended to be safer than the older drug Haldol (haloperidol) and is available as an oral medication, a fast-dissolving tablet and a controlled release injection known as Risperdal Consta.

All antipsychotics work by blocking the neurotransmitter dopamine to decrease psychotic and aggressive behavior. Because it also blocks another neurotransmitter, serotonin, Risperdal is considered an “atypical” antipsychotic. Blocking serotonin makes it more effective in treatment of bipolar disorder and other conditions like aggression in autism.

In addition to the approved uses, Risperdal has been used as a “chemical restraint” in the elderly and was given to hundreds of children in foster care and state custody who were considered combative. Some patients who were given Risperdal suffered serious and irreversible side effects such as abnormal breast growth or gynecomastia and it was shown to increase the risk of death in elderly dementia patients.

Johnson & Johnson was accused of illegally marketing Risperdal for unapproved uses in children and paid billions of dollars in fines and settlements to the U.S. government and several state governments. The companies have been the subject of multiple news reports and are still facing hundreds of lawsuits permanent injuries such as gynecomastia.

Side Effects of Risperdal

Like all medications, Risperdal may cause a number of side effects. Most of these are mild to moderate but some may be severe, cause permanent injury or increase the risk of death.

Common side effects include:

  • Fatigue or sedation
  • Nausea and vomiting
  • Blurry vision
  • Anxiety or restlessness
  • Insomnia
  • Increased heart rate
  • Tremor
  • Increased appetite or weight gain
  • Prolonged erection (priapism)

Risperdal also causes a number of drug interactions which may be harmful or life-threatening. Drug interactions may include:

  • Irregular heart rhythm
    • Nausea medications (Anzemet, Zofran)
    • Beta-blockers (Coreg, Toprol and others)
    • Epilepsy medications (Geodon, Topamax)
    • Antiarrhythmics (amiodarone, procainamide)
    • Fluoroquinolone antibiotics (Cipro, Avelox)
    • Immunomodulators (Xalkori, Gilenya)
    • Platelet inhibitors (Plavix)
  • Increased sedation
    • Pain medications
    • Antidepressants
    • Anxiety medications
    • Other antipsychotics
  • Increased risk of seizure
    • X-ray imaging agents

Serious Side Effects of Risperdal

In addition to common side effects, Risperdal causes serious adverse events which may be severe, permanent or increase the risk of death. Serious adverse events may include:

Gynecomastia

Risperdal stimulates secretion of a hormone called prolactin. This hormone is produced by the pituitary gland and is high when a woman is pregnant or nursing. High levels increase breast tissue and help the body produce milk.

Researchers believe Risperdal triggers the pituitary gland, leading to increased prolactin levels for both male and female users and has been shown to cause gynecomastia or growth of breast tissue in males, some as young as age four. Breast tissue growth is usually a permanent change which may require surgery to correct. Gynecomastia often causes serious emotional problems, particularly in boys, adolescents and young men.

Lactation in girls

Secretion of prolactin is normally responsible for female lactation or milk production after giving birth. Risperdal’s stimulation of prolactin production has caused premature breast development and lactation in young girls who are not of child-bearing age. Lactation has also occurred in males who have developed gynecomastia and in women who are not pregnant or nursing.

Movement disorders

Risperdal may cause movement disorders which may become worse over time. These abnormal movements are known as extrapyramidal symptoms (EPS) and may be permanent, even if Risperdal is discontinued.

Symptoms of EPS may include:

  • Tremor similar to Parkinsons disease
  • Facial tics and abnormal head, shoulder and limb movements (Tardive Dyskinesia)
  • Drooling
  • Difficulty starting movement (akinesia)
  • Restlessness (akathesia)
  • Stiffening of the tongue (torticollis) – may result in suffocation

Many patients will require medication to manage symptoms of EPS.

Death in elderly

Risperdal has been shown to increase the risk of death in elderly patients with dementia. More elderly dementia patients have died from pneumonia, cardiac failure and stroke while Risperdal and the increased risk was not related to the dose amount or how long the medication had been taken. Though the exact cause is unknown, patients with dementia may be more at risk as they are unable to report severe symptoms.

Because of the number of deaths, the FDA required that a “black box warning” be added to prescribing information for Risperdal. A black box waring is the most severe warning that can be issued by the FDA and requires that information is printed at the top of prescribing information, surrounded by a thick, black border.

Diabetes

Risperdal and similar drugs have been linked to an increase risk of development or worsening of diabetes, possibly due to action on the pituitary gland and disruption of normal hormone levels. It may increase the risk for high blood sugar in users with diabetes and may increase the risk of ketoacidosis.

Risperdal Legal Actions and Lawsuits

Since its 1994 approval, Risperdal has been the subject of multiple controversies, disputes and reports involving the FDA and other government agencies.

The FDA issued a 2005 black box warning, about the increased risk of death and required changes to prescribing information. Janssen and parent company, Johnson & Johnson have already paid more than five billion dollars in fines and settlements for fraud, unapproved marketing of Risperdal and other issues.

Illegal Marketing Activity

Janssen’s application for Risperdal use in children had been denied by the FDA in 1996 due to a lack of evidence for safety and effectiveness and a failure to specifically identify disease states for which it would be used. FDA documentation dating back to this time shows that the FDA noted suspicions that the approval had been requested because the medication was already in use in adolescents and children.

Investigations have revealed a 1994 Risperdal product plan that discussed “seeding” of promotional material with underlying suggestions that the product could be used in children and for unapproved uses.

The company has also been accused of other improper marketing practices promoting unapproved uses such the widespread use of:

  • Physician motivational “tools” such as speaker fees, free travel and retreats, consulting agreements and other incentives to “learn” about unapproved uses for Risperdal
  • Monetary incentives and sales motivational goals for pharmaceutical representatives to promote unapproved uses in children with behavioral issues and in elderly patients with dementia
  • Provision of large quantities of free samples to physicians known to be using the medication for unapproved uses
  • Volume based kickbacks paid to the largest pharmacy provider for nursing homes

Some of these practices led to government insurance fraud in programs such as Medicaid and Medicare for which the company paid $172 million in civil penalties and $485 million in criminal penalties to the US government and 45 states.

Between 2010 and 2012, Johnson & Johnson faced settlements in multiple states regarding improper marketing practices including:

  • $1.2 billion in an Arkansas court for 240 thousand cases of Medicaid fraud related to 4,500 deceptive marketing practices
  • $327 million to courts in South Carolina
  • $258 million to courts in Louisiana
  • $158 million to courts in Texas

Some of these awards have been dismissed due to technicalities but in 2013, Johnson & Johnson paid approximately $2.2 billion in settlements with the Department of Justice and state and federal agencies regarding improper marketing practices from 1999 to 2005.

The DOJ and the attorney generals from 45 states and the District of Columbia claimed that claimed that as early as 1994, the company had promoted the medication for pediatric use and that kickbacks were paid to doctors and the largest nursing home pharmacy in the U.S. for the use of Risperdal.

Government agencies all accused the company of aggressive marketing of the medication for use in children with disabilities and in the elderly. In 2014, a settlement was also awarded to the State of Montana for $5.9 million.

Several cases of gynecomastia have been settled out of court and a 2019 drug injury lawsuit resulted in a $8 billion verdict against Risperdal’s manufacturer Janssen and parent company Johnson & Johnson but is likely to be appealed. This followed a $70 million verdict in Philadelphia in July 2016, but other cases have not been successful.

Johnson & Johnson and Janssen are still facing over 13,000 Risperdal lawsuits, most of which are due to cases of gynecomastia.