Risperdal

Risperdal

Risperdal (risperidone) is an antipsychotic medication, approved to treat schizophrenia, bipolar disorder symptoms of autism but has been used for a number of other conditions which were not approved.  It has also caused serious side effects in some patients including breast tissue development in children and increased death risk in the elderly.

Risperdal is the brand name for risperidone. It is used to treat schizophrenia, bipolar disorder and 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 dopamine to decrease psychotic and aggressive behavior but because it also blocks 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 and it was shown to increase the risk of death in elderly dementia patients.

Risperdal is converted in the body to the active metabolite, paliperidone. After Risperdal’s patent expired, Johnson & Johnson developed paliperidone as a new antipsychotic, Invega and as a sustained release injection Invega Sustenna, which has also caused a number of problems.  Manufacturing lots of Risperidal have been recalled several times due to contamination concerns and Invega Sustenna was once recalled due to cracks in the syringe packaging.

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
  • Anxiety or restlessness

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:

Breast tissue development in boys

Risperdal stimulates secretion of a hormone called prolactin.  It has been shown to cause gynecomastia or growth of breast tissue in males, some as young as age four.  Breast tissue growth often causes serious emotional problems, particularly in adolescents and is usually permanent unless surgery is performed.

Lactation in girls

Secretion of prolactin is 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.

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

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.  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.

FDA action and lawsuits of Risperdal

Since its 1994 approval, Risperdal has been the subject of multiple controversies, disputes and reports.  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 unapproved marketing of Risperdal and personal injuries like gynecomastia and still faces legal action.

Patients or loved ones of those who developed gynecomastia or permanent injury or who died after taking Risperdal may be eligible for compensation and should seek legal advice.

 

Risperdal References

Drugs.com, (2017), Risperdal (risperidone) Drug Interactions, Accessed on 04 April 2017 http://www.drugs.com/drug-interactions/risperidone,risperdal.html

Feeley, J., & Fisk, M. (27 September 2012). J&J Pushed Risperdal with Golf, Popcorn, Witness Says. Bloomberg. Accessed on 04 April 2017 http://www.bloomberg.com/news/2012-09-25/j-j-pushed-risperdal-with-golf-popcorn-witness-says.html

Food and Drug Administration (26 November 2012), Pediatric Advisory Committee,  Drug Utilization Review – Risperdal,  Accessed on 04 April 2017  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM342205.pdf

Food and Drug Administration, (2017), Risperdal prescribing information, Accessed on 04 April 2017  http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf

 

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

WebMD, (2014) Drugs & Medications – Risperdal Oral, Side Effects, Accessed on 04 April 2017 http://www.webmd.com/drugs/drug-9846-Risperdal+Oral.aspx?drugid=9846&drugname=Risperdal+Oral&pagenumber=6

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