Risperdal Lawsuit Information

February 28, 2014

Risperdal is an antipsychotic mediation used to treat a range of conditions.  It contains risperidone, and it is sometimes referred to by that name.  Taken orally, it is prescribed for both children and adults. It helps restore the balance of natural substances in the brain, so it is used to treat several mood disorders, including schizophrenia and bipolar disorder.

Risperdal as a Treatment Option
Working to alter and correct brain chemistry, Risperdal is used to treat an incredible range of conditions and symptoms.  People who are struggling with moods, having hallucinations and living with emotional withdrawal may be prescribed Risperdal on a long-term basis.  It’s also used as a short-term treatment for behavioral problems like verbal or physical aggression, agitation, and general suspiciousness. It is commonly prescribed to children and adults, and it’s also used for senior citizens who are struggling with dementia.  In addition to treating bipolar and schizophrenia, doctors have also used Risperdal to help children with autism or ADHD control their urges and behaviors.

The dose size ranges from 0.5mg to 8mg a day, and doctors will generally start with a lower dose and move up to find the right balance.  Patients are encouraged to take a missed dose as soon as it is remembered.  However, the doses should never be doubled in order to make up for one that was previously missed.

Side Effects of Risperdal
When Risperdal is prescribed, the hope is that it will help the patient calm down and exert better control over themselves. However, there are side effects that patients should be aware of before they begin using this medication.

The most common side effects include sudden, jerky, involuntary movements of the head, neck, arms or eyes.  Patients may also note dizziness, general fatigue, fever, tiredness and nausea.  Weight gain may occur, and dry mouth can become a problem.  Mild skin rash has been reported, as well as insomnia, feeling restless and a cough or throat.

The more serious side effects can indicate an allergy to risperdone.  Patients should watch for fever or stiff muscles, drooling and tremors, seizures, chills, nosebleeds, white patches on the inside of the mouth or lips, difficult swallowing, lightheadedness and penis erections that are painful or last more than four hours.

There are other side effects that are not as commonly known.  These include aggressive behavior, changes in vision, trouble concentrating, memory problems, shuffling walk, twisting body movements and unusual secretion of milk.  There are also numerous claims that the use of risperdone causes gynecosmastia, or the development of male breast tissue in boys and teenagers.

Pediatric Clinical Trials
Not all medications are safe for adults and children.  Risperidone has commonly been used to treat children with autism, bipolar disease and schizophrenia.  Clinical trials found that the most common adverse effect was somnolence, or a strong desire for sleep.  Other issues included fatigue, increased appetite, upper respiratory tract infections, increased salivation, constipation, dry mouth, dystonia, tremors, dizziness, tachycardia, confusion and weight gain.  The medication may also cause problems such as hyperglycemia or diabetes.

The History of Risperdal
This medication was only introduced in 1993, but it quickly became one of the most profitable and popular medications in America.  The number of prescriptions quickly topped one million in 1996.  The first public indication of serious problems came in 2001 when the Miami Herald reported that the medication was causing serious side effects among teenagers who were in Florida foster homes.  In these cases, the mediation was being used as a chemical restraint.

Janssen Pharmecutica issued a statement to Canadian doctors regarding Risperdal in 2002.  It was a warning advising doctors of the risks associated with using Risperdal to treat elderly people with dementia.  There were allegations that the drug was responsible for 37 stroke-like events and as many as 16 deaths.

In the United States in 2003, Risperdal was officially approved by the FDA as a treatment for bipolar disorder.  That same year, Janssen sent a similar warning letter to American doctors.  However, doctors continued to use the medication to treat mood disorders in adults and children.  Today, it continues to be the most prescribed antipsychotic drug in the country.

Action to Take
People who have concerns about the side effects they or their child are seeing while taking Risperdal, they can take action.  They can work with their doctors to find other medications that will prove effective without the most serious side effects.   If the medication has caused serious problems that required medical attention or additional counseling, then consumers may be able to seek compensation from manufacturer Johnson and Johnson.

A Landmark Settlement
Whistleblowers played a fundamental role in the recent settlement between Johnson & Johnson and consumers who claimed that they were harmed by taking Risperdal.  There were eight whistleblowers, including five former employees.  These people played part of the 10-year probe that led to massive settlement.  There were criminal and civil charges in the lawsuit regarding how Risperdal was marketed.  Prosecutors made the argument that Johnson & Johhson was marketing Risperdal for use in children before this was approved by the FDA.  The company is also accused of concealing side effects such as gynecomastia.  The company plead guilty to charges that they illegally marketed the drug for use in elderly dementia patients, but they maintained their innocence regarding marketing the drug for pediatric use.

The charges regarding hiding information on serious side effects and illegal marketing have been echoed in hundreds of lawsuits against Johnson & Johnson.  There are currently several lawsuits pending against the manufacturer.  People are seeking damages to cover medical bills, pain and suffering, emotional distress, and lost wages.

The Link Between Gynecomastia and Risperdal
This condition was first linked to the medication in 1999.  The initial study indicated that gynecomastia could occur if Risperdal were taken along with Prozac, an antidepressant. In 2006, the Journal of Clinical Psychopharmacology published a study showing that adolescents who took Risperdal had significantly higher levels of prolactin.  In 2009, a study published in the Journal of Child and Adolescent Psychopharmacology indicated that the elevated prolactin levels could remain in the body for up to two years.

Researchers believe that Risperdal works to block dopamine. This results in the pituitary gland releasing prolactin.  This milk producing hormone stimulates breast milk in women.  One of the listed side results of Risperdal is the spontaneous production of breast milk.  In men, this excessive hormone can lead to gynecomastia.  The treatment for excessive breast tissue is liposuction, breast reduction surgery or mastectomy.  Anyone who is using this medication is encouraged to watch for the growth of unwanted breast tissue.  It may present on one or both sides of the body, and it can be uneven or lopsided when present in both breasts.   Symptoms include pain, tenderness, swelling and nipple discharge.

It is important to note that Risperdal will not cause gynecomastia in all people.  The drug continues to be one of the most heavily prescribed antipsychotic medications, and the side effects do not affect all users.  However, consumers should be aware of the risks so that they can make an informed decision about their personal health care.  Further, those who are taking the medication should be aware of the full risks and understand what their options are if they start experiencing some of the most serious side effects.

http://www.rxlist.com/risperdal-drug.htm – opening
http://www.webmd.com/drugs/drug-9846-Risperdal+Oral.aspx?drugid=9846&drugname=Risperdal+Oral  – opening paragraph
http://chealth.canoe.ca/drug_info_details.asp?brand_name_id=970 – treatment option
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2536539/ – treatment option
http://www.rxlist.com/risperdal-side-effects-drug-center.htm – treatment and side effects
http://www.drugs.com/sfx/risperdal-side-effects.html – side effects
http://www.resource4risperdalinfo.com/topics/risperdaldrugtimeline.html – history
http://www.medscape.com/viewarticle/571416_6 – pediatric clinical trials
http://www.marketwatch.com/story/risperdal-lawsuit-news-bernstein-liebhard-comments-on-whistleblower-rewards-in-federal-risperdal-settlement-2013-12-16 – settlement
http://www.drugdangers.com/risperdal/gynecomastia.htm – link between

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