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Risperdal

risperdal gynecomastia lawsuit

Renowned manufacturer, Johnson & Johnson invested millions of dollars in the antipsychotic drug Risperdal, but instead of profits skyrocketing as planned; J&J now faces thousands of lawsuits due to misbehavior of the drug.

WHAT IS RISPERDAL

Risperdal and another drug manufactured by Johnson & Johnson known as Invega are powerful antipsychotic drugs used to treat schizophrenia as well as bipolar disorder and autism. They are also approved to aid towards ADHD, sleep difficulties and anxiety. Risperdal was first approved by the FDA for use in 1993 and Invega in 2003.

LAWSUITS AND LITIGATION

While Risperdal brought in reasonable sales, profits did not maintain their high levels. After its release, Risperdal sales peaked at $4.5 billion dollars in 2007. After the patent protection became extinct, Johnson & Johnson reported a mere $358 million in 2012 as well as Invega’s $424 million dollar profit in 2010. After news of the drugs adverse reactions such as gynocomastia (breast development in boys) patients and loved ones immediately filed lawsuits against Johnson & Johnson. Reports were also found alleging that Johnson & Johnson marketed Risperdal to adolescents before gaining full approval from the FDA.

HOW IT WORKS

Risperdal and Invega go hand in hand and have many similarities when it comes to being absorbed by the body. Risperdal and Invega are made up of chemical ingredients all metabolites. Invega is Risperdal’s most vital metabolite. They both have the same physiological effects yet are absorbed by the body in different ways.

Risperdal and Invega, also called atypical antipsychotics target the chemicals dopamine and serotonin in the body. Commonly reviewed next to Abilify, Seroquel and Zyprexa, Risperdal is not confined to the form of a tablet. It is available in liquid, tablet and injectable forms (Risperdal Consta). Invega on the other hand is an injection needed only once a month and was approved in 2009 to also function while combined with various medications such as antidepressants and lithium.

MAJOR SIDE EFFECTS OF RISPERDAL

  • Breast development in boys
    • Gynecomastia is the surplus of levels of prolactin in the body which stimulate breast growth and milk production in women. Adolescent boys who take Risperdal are at risk of Gynecomastia, which in most cases involves revision surgery to remove.
  • Movement Disorders
    • Extrapyramidal (EPS) symptoms as well as tardive dyskinesia are movement disorders that are triggered by Risperdal and bring on involuntary and painful muscle spasms. Another dangerous side effect called dystonia brings on involuntary and uncontrollable sounds.
  • Diabetes
    • Both Risperdal and Invega have been linked to Type 2 diabetes and an onset of high blood sugar.
  • Heart Problems and Death
    • Antipsychotics are known to carry risks of cardiac arrest, and the warning that follows Risperdal and Invega states an increased threat of death in senior patients with dementia and are known to cause tachycardia (rapid heart rate).

OTHER MINOR SIDE EFFECTS OF RISPERDAL

  • Insomnia
  • Vomiting
  • Drooling
  • Abdominal pain
  • Priapism (prolonged penile erection)
  • Dizziness

SCANDAL IN THE MARKET

Physicians are permitted to prescribe medications for unapproved uses; however, the law forbids manufacturers from openly promoting such drugs for off-label uses. In 2012 government officials and securities claimed that J&J illegally encouraged the off-label use of Risperdal in children before it had been approved by the FDA. Reports prove that Johnson & Johnson favored physicians for giving positive speeches on the drug, paid for various vacations and outings and gave bonuses to salespeople who sold Risperdal to pediatric specialists. Although Johnson & Johnson did not adhere with the government’s requirements to state in reports that the company increased prolactin levels (that in turn stimulate breast growth), J&J did agree to pay 2.2 billion dollars in 2013 to settle alleged charges.

RECALLS

After the downward spiral of Risperdal, Johnson & Johnson now face billion dollar government clearance costs that absorb evidences of illegal marketing all of which totals $2 billion. Problems with the drug begin with Johnson & Johnson releasing the drug to children for off-label use through the years of 1999 to the early 2000’s.

2011 Risperdal recall due to drug contamination of chemicals used to treat wood pallets
2011 Invega recalled 70,000 syringes after ascertaining cracks in syringes which could lead to possible infection.
2013 Risperdal recall due to mold.

Sources:

Conley, Robert R. (2000). Risperidone Side Effects. Journal of Clinical Psychiatry 61(suppl. 8):22. Feeley, J., & Fisk, M. (2012, September 10). J&J Settles Risperdal Lawsuit on Opening Day of Trial. Bloomberg. Retrieved from http://www.bloomberg.com/news/2012-09-10/j-j-settles-risperdal-lawsuit-on-opening-day-of-trial.html

Feeley, J., & Fisk, M. (2012, September 27). J&J Pushed Risperdal with Golf, Popcorn, Witness Says. Bloomberg. Retrieved from http://www.bloomberg.com/news/2012-09-25/j-j-pushed-risperdal-with-golf-popcorn-witness-says.html

Food and Drug Administration. (2011). Risperdal package insert §8.4. Retrieved from website: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf

Foster, Rachel H. and Goa, Karen L. (1998). Risperidone: A Pharmacoeconomic Review of its Use in Schizophrenia. Pharmacoeconomics 14(1):105. Harris, G. (2008, November 18). Use of antipsychotics in children is criticized. The New York Times, A20. Retrieved from http://www.nytimes.com/

Johnson & Johnson. Investor Relations, (2007-2013). Johnson & Johnson reports fourth-quarter and full-year results. Retrieved from http://www.investor.jnj.com/sales-earnings.cfm

NAMI: National Alliance on Mental Illness, (2013). Risperdal. Retrieved from http://www.nami.org/Template.cfm?Section=About_Medications&Template=/TaggedPage/TaggedPageDisplay.cfm&TPLID=51&ContentID=66283

Rockoff, Jonathan. (2013, May 9). J&J Balks on Deal to Settle U.S. Probe. The Wall Street Journal. http://psychcentral.com/news/2011/06/18/recall-of-antipsychotics-risperdal-risperidone-issued/27056.html

Silverman, E. (2012, September 11). J&J Sees Male Breasts And Quickly Settles Risperdal Suit. Forbes. Retrieved from http://www.forbes.com/sites/edsilverman/2012/09/11/jj-sees-male-breasts-and-quickly-settles-risperdal-suit/

Invega. (2014) National Alliance on Mental Illness. Retrieved from: http://www.nami.org/Template.cfm?Section=About_Medications&Template=/TaggedPage/TaggedPageDisplay.cfm&TPLID=51&ContentID=69548

Drug Utilization Review. (2012, Nov. 26). Mistry, K.; Chai, G.; Staffa, J. Department of Health and Human Services. Public Health Service. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Office of Surveillance and Epidemiology. Retrieved from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM342205.pdf

Invega. (2013, Sept. 30). Janssen. Retrieved from: http://www.janssencns.com/invega

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