Risperdal

Risperdal (risperidone) is an “atypical” antipsychotic approved to treat schizophrenia and bipolar disorder in adults and children and autism in children. It was approved by the food and Drug Administration (FDA) in 1993 and is manufactured by Janssen, a division of Johnson & Johnson, the largest pharmaceutical and medical products company in the world.

In addition to the approved uses, Risperdal has been used for “off-label” indications which were not approved by the FDA. One of the common unapproved uses for Risperdal has been the treatment of behavioral disorders such as psychotic episodes, aggression, and agitation in patients with dementia which may increase the risk of death.

In addition to the many side effects of Risperdal, the medication has been shown to pose a serious risk to elderly patients with dementia. These health risks prompted the FDA to require a “black box warning” on the prescribing information for Risperdal.

What Is Risperdal?

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.

Who Manufactures Risperdal?

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.

How Does Risperdal Work?

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 the treatment of bipolar disorder and other conditions like aggression in autism.

What Is Risperdal Prescribed to Treat?

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 and permanent injuries such as gynecomastia.

Is There Illegal Marketing Activity for Risperdal?

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 as 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.

What Lawsuit Settlements Were There Regarding Improper Marketing?

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 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.

What Are the 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
  • A prolonged erection (priapism)

What Side Effects Can Be Caused by Drug Interactions with Risperdal?

Risperdal also causes a number of drug interactions that 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

What Serious Side Effects of Risperdal Are There?

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:

Can Risperdal Cause Gynecomastia?

Gynecomastia is defined as the abnormal development of breast tissue in males. While it is troublesome in adults, it is particularly disturbing in juveniles and children. In addition to the physical changes, children are also often subjected to significant emotional and psychological trauma due to gynecomastia.

Risperdal stimulates the 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 that may require surgery to correct. Gynecomastia often causes serious emotional problems, particularly in boys, adolescents, and young men.

What Are the Symptoms of Gynecomastia?

Gynecomastia caused by Risperdal may develop in one or both breasts. The breast development may also be uneven or lopsided. It does not generally pose significant health risks but may be extremely emotionally and psychologically damaging, particularly in children and adolescents. Many Risperdal patients with gynecomastia experience lasting social embarrassment and trauma that continues into adulthood.

Physical symptoms of Risperdal related gynecomastia include:

  • Pain and tenderness in the breast area
  • Swelling and enlargement of the nipples
  • Growth in the breast area
  • Discharge from the nipples

How Is Gynecomastia Treated?

Gynecomastia caused by Risperdal will usually not go away even if the drug is discontinued. In mild cases where not much mammary tissue has developed, liposuction may be used to remove the tissue but in more extensive cases, a breast reduction or mastectomy surgery will be required. This may also require the removal of skin in a chest reconstructive procedure.

In addition to the emotional trauma that is likely to result from the development of gynecomastia, the patient may be subjected to significant surgical pain and may require a lengthy period of healing.

Can Rispderdal Cause 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.

Can Risperdal Cause 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 Parkinson’s disease
  • Facial tics and abnormal head, shoulder, and limb movements (Tardive Dyskinesia)
  • Drooling
  • Difficulty starting movement (akinesia)
  • Restlessness (akathisia)
  • Stiffening of the tongue (torticollis) – may result in suffocation

Many patients will require medication to manage symptoms of EPS.

Can Risperdal Cause Diabetes?

Risperdal and similar drugs have been linked to an increased 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.

Can Risperdal Cause Death in the 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 were 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 warning 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.

Has the FDA Issued a Warning About Risperdal?

A black-box warning or boxed statement is the most severe warning that medication can receive from the FDA. It is placed at the top of prescribing information in a box with a thick black border so that health care professionals will see the warning before prescribing the medication. 

The black box warning on prescribing information for Risperdal was required by the FDA to be added to medication labeling in September of 2006. A clear statement regarding the dangers of administering Risperdal to elderly patients in the black box indicates that the medication poses an increased risk of death.

Why Did the FDA Issue a Black Box Warning for Risperdal?

Risperdal’s black box warning was prompted by a review of 17 placebo-controlled studies with 5,106 elderly patients on antipsychotics over a period of about 10 weeks. Study results showed that elderly patients who took Risperdal had a risk of death that was 1.7 times higher than those who took the placebo. The specific causes of death varied from patient to patient but were primarily related to cardiovascular causes such as heart failure or heart attack and infections such as pneumonia.

Though the exact cause of increased risk is unknown, some experts have suggested that it may be caused by an inability of elderly patients with dementia to communicate or report difficulty breathing or other symptoms which may indicate complications.

The black box warning on Risperdal outlines the increased risk of mortality (death) in elderly patients with dementia and states that Risperdal is not approved to treat these patients.

What Risperdal Lawsuits Are There?

The first lawsuit regarding harm caused by Risperdal use was filed in 2010 by a 21-year-old man who had taken Risperdal for off-label use between 1999 and 2004 and suffered physical and emotional trauma due to gynecomastia or the development of male breasts. In 2012, the case was settled by Johnson & Johnson on the first day of trial for an undisclosed amount, prior to the plaintiff’s attorney calling a former company CEO as a witness.

The same year, Johnson & Johnson was accused of improper marketing practices and was fined $1.2 billion in an Arkansas federal court due to claims that they downplayed risks and that over 240,000 cases of Medicaid fraud and 4,500 deceptive practices had been caused by the manufacturers marketing activity.

What Risperdal Lawsuit Settlements Are There?

Also, in 2012 the company settled lawsuits with 36 states and the District of Columbia regarding improper marketing techniques, specifically for the treatment of children. The cases were settled by the payment of $181 million. Other state cases had also been settled including $327 million in South Carolina, $258 million in Louisiana, and $158 million in Texas.

During 2012, Bloomberg News reported over 420 additional lawsuits including over 100 which were related to gynecomastia and the company’s failure to adequately warn of the risk. Six gynecomastia suits were settled for undisclosed amounts before the FDA Commissioner could be called as a witness.

The company paid $2.2 billion in fines and penalties to the US Department of Justice in 2013 to avoid prosecution related to misbranding of Risperdal, which is the largest settlement of its type. Several medical injury trials have been conducted and resulted in multi-million dollar judgment awards to plaintiffs who were injured by Risperdal use, including a 2019 award for $8 billion in punitive damages to a Philadelphia man which has been appealed, and a $70 million verdict which has been upheld.

Are There Any Current Risperdal Lawsuits?

As of 2022, Johnson & Johnson has announced that it has settled essentially all of the thousands of lawsuits that it faced from men who had claimed they developed male breast tissue after taking Risperdal to treat a psychiatric condition. The total amount in settlements and legal costs for those cases was $800 million. There are few, if any, outstanding lawsuits against Johnson & Johnson regarding Risperdal.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

View Sources

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