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Risperdal

The Risperdal injury lawsuit attorneys at the Drug Law Center are representing many patients who have suffered harm from the serious side effects caused by the mental disorder treatment medication.

Introduction

Risperdal RecallRisperdal (risperidone) is an effective treatment for managing mental and mood disorders including bipolar disorder, schizophrenia, and irritability. The drug is classified as an SGA (second-generation antipsychotic) that works by rebalancing serotonin and dopamine levels to enhance behavior, mood, and thinking. Advancements in new antipsychotic medications have provided much better results than older antipsychotic drugs that tended to affect just dopamine levels. To be effective, the medication must be taken for at least 4 to 6 weeks.

The History of Risperdal

Risperdal and the generic form risperidone was initially developed by the pharmaceutical giant Johnson & Johnson in the early 1990s. The drug was first made available in the medical marketplace two decades ago from J & J subsidiary Janssen pharmaceuticals Inc., after passing approval by the US Food and Drug Administration (FDA) in 1993. Initially, the FDA approved the medication only for the treatment of schizophrenia in adults.

By early 2005, Janssen Pharmaceuticals adjusted the Black Box Warning to the Risperdal label when the FDA became aware of a drug related problem when elderly patients suffering from dementia were shown to have an increased potential of unexpected death. The following year (2006) Duke University conducted research revealing that the medication has the potential of causing gynecomastia (male breast growth. Additionally, the study revealed that some young girls taking the drug were lactating before puberty.

By August 2007, approval for the use of the drug in children (13 to 17 years old) to treat bipolar disorder was finally granted by the FDA. Further studies revealed in 2008 that taking risperidone could stimulate prolactin (milk production) in boys. Even though the FDA conducted meetings where side effects and adverse reactions occurring in children on Risperdal were discussed by doctors, no further strengthening was done on the drug’s warning label. Five years later in August 2012, a $181 million settlement was reached between Johnson & Johnson and 36 states including Washington D.C. over the marketing of the medication.

Approved and Off-Label Uses of Risperdal

In 1993, Risperdal was first approved by the FDA to treat schizophrenia in both adolescents and adults. The approval was later expanded by the Food and Drug Administration to include the treatment of autism spectrum disorders in adolescents and children and bipolar disorder in adolescents and adults.

Many doctors prescribe Risperdal and risperidone for off-label purposes even though they have yet to be approved by the FDA. Some of these conditions include ADHD (Attention Deficit Hyperactivity Disorder), depression, sleep difficulties and anxiety.

Doctors treating children suffering from ADHD often prescribe Risperdal and risperidone even though there is minimal clinical evidence to support the notion that the drug can successfully treat the child’s disorder. Alternatively, in 2013, a study released by Consumer Reports revealed that there may be unanticipated side effects including the increased potential of developing Type II diabetes, high cholesterol, and weight gain. Common uses that have not been officially approved by the FDA include the treatment of:

  • Dementia
  • Monotherapy (major depressive disorder)
  • Substance abuse
  • Parkinson’s disease (psychosis related)
  • Tourette syndrome
  • Posttraumatic Stress Disorder when used concomitantly with antidepressants
  • Borderline personality disorder
  • Generalized anxiety disorder
  • Anorexia nervosa to maximize body weight gain
  • OCD (obsessive compulsive disorder when used as adjunctive therapy)
  • Delirium involving frightening psychotic incidences and agitation
  • Vomiting/nausea/hiccups

Many doctors prescribe risperidone as a treatment for a delusional disorder. Many conventional antipsychotic medications (neuroleptics) have been used since the mid-1950s to treat a variety of mental disorders because they block the brain’s dopamine receptors. Scientists and researchers have yet to find a way to prevent delusional disorder. Even so, Risperdal and other antipsychotic medications are not always effective.

Risperdal Generates Billions Every Year

Janssen Pharmaceuticals and its parent company Johnson & Johnson manufacture Risperdal generating billions of dollars every year. In 2007, the company generated over $4.5 billion for that medical drug alone that was diminished to just over 350,000,005 years later when the company’s patent protection had expired.

Even though other drug makers can now produce risperidone, Johnson & Johnson still generates billions in profits every decade, often, because of illegal marketing practices.

Risperdal Black Box Warnings

Additional side effects and adverse reactions were added to black box warning labels on risperidone and respite all in 2005. The FDA issued a strict warning that dementia patients who are suffering behavioral disorders, agitation, aggression, and psychosis seem to be at higher risk of unexpected death from taking the drug. The risperidone-related deaths involved cardiovascular problems, sudden death, heart failure, pneumonia, and other infectious conditions.

Gynecomastia is also a serious problem that commonly occurs in men and boys taking Risperdal and risperidone, where their breast tissue enlarges, particularly during their adolescent years. In addition, the drug is known to significantly enhance levels of prolactin, a pregnancy-related hormone that naturally stimulates milk production.

It is highly recommended from the British National Formulary that Risperdal takers gradually withdraw from the antipsychotic medication to help prevent adverse reactions including rapid relapse and acute withdrawal syndrome. Some research reveals that quickly withdrawing from the medication might produce schizophrenia-like symptoms even in patients who were previously healthy.

The drug manufacturer and doctors recommend avoiding the use of Risperdal and risperidone if certain conditions are present that include:

  • Coronary artery disease
  • Heart disease
  • Previous heart attack
  • Heart arrhythmia problems
  • High blood pressure
  • Dementia
  • Kidney or liver disease
  • High triglycerides/cholesterol levels
  • Low white blood cell count
  • Difficulty in swallowing
  • Previous breast cancer
  • Previous seizures
  • Parkinson’s disease
  • Dehydration
  • While taking blood pressure drugs

Common Risperdal Side Effects & Adverse Reactions

The first sign of any side effect or adverse reaction from taking Risperdal and risperidone, it is essential to seek out immediate emergency medical attention. This includes the swelling of the throat, tongue, lips or face, or any difficulty in breathing. The most common side effects and adverse reactions from taking the medication include:

  • Uncontrollable facial muscle movements that might involve excessive blinking, tongue movement, frowning, lip smacking, and chewing.
  • Severe reaction to the nervous system including high fever, rigid (stiff) muscles, confusion, sweating, tremors, uneven or fast heart rate, experiencing the sensation of passing out.
  • Low white blood cell count that leads to ill feeling, sudden weakness, sore throat, chills, fever, swollen or red gums, mouth sores, skin sores, difficulty in swallowing, trouble breathing, coughing, flu or cold like symptoms.
  • A low blood stream platelet count that leads to unusual bleeding of the rectum, vagina, mouth or nose along with purple or red pinpoint skin spots, and easy bruising.
  • Painful erections lasting four hours or more.
  • High blood sugar levels leading to increased urination, excessive thirst, dry mouth, hunger, drowsiness, blurry vision, dry skin, weight loss, or fruity breath odor.
  • Headaches, upset stomach, weight gain, constipation, and depressed mood.

Contraindications

In March 2016, the Food and Drug Administration issued a comprehensive contraindication report for risperidone (Risperdal) and paliperidone – a metabolite of risperidone. The summary of the contraindications report reads:

“RISPERDAL/RISPERDAL CONSTA/INVEGA(s) is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL/RISPERDAL CONSTA/ INVEGA(s) formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.”

To minimize the effects of feeling lightheaded or dizzy, try getting up slowly from a sitting position. Some patients taking Risperdal develop NMS (neuroleptic malignant syndrome), an extremely rare, a life-threatening condition that often produces anatomic dysfunction, altered mental status, and muscular rigidity.

Taking Risperdal with Other Drugs

Taking Risperdal or risperidone with other medications can cause sleepiness or slow breathing that can produce life-threatening, dangerous side effects. Because of that, it is recommended to avoid using the medication concomitant with narcotic pain medicines, sleeping pills, muscle relaxers, prescribe cough medicines, and drugs used for treating seizures, depression, or anxiety.

Other medications used concomitantly with risperidone or Risperdal could cause an undesired adverse event. These include herbal products, vitamins, over-the-counter (OTC) drugs and prescription medications. Only doctor or pharmacist can provide appropriate instructions on how to use the drug or stop taking the medication.

Successful Lawsuits and Monetary Awards

  • In February 2015, a young male plaintiff won his case against Johnson & Johnson and Janssen Pharmaceuticals after he developed large breasts at eight years old from taking risperidone. He was awarded $2.5 million in damages because the jury said that the company failed to adequately warn him of the potential side effects including the development of breast tissue.
  • In October 2015, a jury in California awarded a victim of Risperdal $5.6 million in a Janssen Pharmaceuticals wrongful death lawsuit after a man died from the medication while participating in a clinical study.
  • In April 2016, Janssen Pharmaceuticals reached a settlement with the Attorney General of Kentucky with a payment of more than $15.5 million for failing to warn consumers of the potential risk of developing gynecomastia and the continuing marketing practices of using the drug off-label.
  • In June 2016, a massive $76.6 million verdict was awarded against J & J subsidiary Janssen Pharmaceuticals. The judge in the case upheld the verdict even though the defendant had filed many post-trial motions in the hopes of having the monetary award amount lowered.

Am I Eligible to File a Lawsuit?

Eligibility for filing a Risperdal or risperidone lawsuit requires having taken the medication under doctor’s orders and developing side effects that might include the development of male breast tissue. Filing and successfully resolving a lawsuit or claim against the drug maker usually provides adequate financial compensation to recover economic damages. Some of these include physical pain, disfigurement, emotional anguish, and mental harm as a direct result of gynecomastia side effects.

Obtaining Legal Representation

If you or a family member suffered serious side effects while taking the antipsychotic medication, it is crucial to speak with our Risperdal injury attorneys at the Drug Law Center. Time is of the essence. Many plaintiffs have lost their ability to seek financial compensation when their Risperdal lawsuit was dismissed because the state statute of limitations in their case had already expired. Our law firm can determine whether your case meets the eligibility criteria.

Our attorneys can fight on your behalf to ensure your family receives full financial compensation for the injuries caused by the medication. We invite you to contact us today to discuss your case for free. Our competent attorneys have successfully resolved many Risperdal lawsuits. We provide a “no win/no fee” guarantee. This means you will always nothing for our legal services unless we obtain an acceptable settlement negotiated out of court or win your case at trial in front of a jury.

Sources:
https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_Psychiatry_Guide/787137/all/Second_Generation_Neuroleptics
https://my.clevelandclinic.org/health/articles/delusional-disorder
http://www.mayoclinic.org/drugs-supplements/risperidone-oral-route/description/drg-20067189
http://www.risperdalconsta.com/
https://www.fda.gov/forindustry/userfees/genericdruguserfees/ucm512491.htm

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