Risperdal Long Term Side Effects

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I have to tell you that I find the information regarding the Risperdal long term side effects terribly unsettling. Thankfully at this time we do not have to use any medication for my daughter’s microcephaly and autism.  Yes, I know, I am very blessed! `I have never been one to use drugs and so I am very happy we haven’t been faced with conditions that would prompt medication for my special needs granddaughter.   However, recently our respite provider brought the Respirdal drug issue to my attention. I have her to thank for bubbling this to the surface for all of us.

The Food and Drug Administration has only approved two drugs for treating some of the difficult symptoms of autism; Risperdal, also known as risperidone, and Abilify also known as aripripazole.  Other drugs that could be prescribed are considered to be “off-label” medications and doctors are allowed to prescribe these even though the drug itself may not have been tested and approved for use in certain applications or with children.  This is exactly what happened with Risperdal.  It was approved for use in adults after 1984, but not children until August 2006 yet some kids were being given the drug much earlier than that.  Like the young man who sued Janssen Pharmaceutical when he turned 21 because of his side effects after being on the drug since 2003 when he was nine years old.

Package of tablet form Risperdal

Package of tablet form Risperdal

 

RISPERDAL® Tablets, ¬RISPERDAL® M-TAB® Orally Disintegrating Tablets, and RISPERDAL® Oral Solution are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560.
The drug insert was revised April 2014 © Janssen Pharmaceuticals, Inc. 2007 and summarizes the side effects of this approved drug.

 

UPDATE Notice as of February 2016:  As a matter of interest and because Risperdal is what you can consider a ‘hot topic’ here are some interesting facts about the money earned through sales of this drug.   It is easy to see from these figures that Risperdal has been a financial success for this pharmaceutical company.  In 2007 the sales peaked at more than $4.5 billion.  Once the patent protection was suspended the name-brand sales in 2012 were $358 million.  For a related drug having similar serious side effects, in 2010 Invega sales reached $424 million.  One can see there is a lucrative end result for prescribing this drug.

What Exactly Is a Side Effect

A side effect is caused when normal doses of a medication create unwanted responses.  It can be mild or severe effects, temporary or permanent.  What the drug insert says about Risperdal is that the listed side effects are not experienced by everyone taking this medicine, that the percentage of people reporting side effects are at least 1%.  Now that doesn’t seem like much at all.  But what if that 1% is our child?  Think of it this way, 1% of 100,000 is 1,000 people.  What if our child were just one in that 1,000?  Would it matter that the side effects can be managed or go away themselves over time?  This is what the drug company is saying and frankly, the facts I’ve uncovered state otherwise, in fact, may even involve surgery.  I’m just not convinced I would want my daughter to experience early onset of her breasts at at time when she would not be emotionally prepared to handle the adolescent repercussions, just because a doctor someday could recommend she be put on Risperdal.

SIDE EFFECTS. REALLY?

Yes, really!  Potentially really debilitating side effects.  Here is the short list:

Agitation

Having a Dry Mouth is just one of several side effects

Having a Dry Mouth is just one of several side effects

Anxiety
Constipation
Difficulty sleeping and staying asleep
Dizziness
Diarrhea
Dry mouth
Headache
Increased amount of saliva
Indigestion
Joint aches Muscle stiffness
Nausea Restlessness
Runny nose Trembling
Unusual tiredness Vomiting
Weight gain

More Serious Side Effects

These would require calling one’s doctor as soon as possible.  This is a modified list of the serious symptoms that are in the drug insert.

Depression, One of the Many More Serious Side Effects

Depression, One of the Many More Serious Side Effects

Abnormal movements of the face, tongue or body              Mask-like face

Breast enlargement (men)                                                        Menstrual changes

Changes in sexual function                                                       Muscle twitching or spasms (face, neck or body)

Changes in vision                                                                        Rigid muscles

Difficulty concentrating                                                            Sleep disorder

Depression                                                                                   Slowed movements

Fainting                                                                                         Swelling of the body, arms, legs

Faster heart rate                                                                          Symptoms of a blood clot

Flu-like symptoms                                                                      Tingling/prickling/numbness of skin

Increased heart rate                                                                    Trembling

High blood pressure

And if this wasn’t enough…

there are even more serious conditions that would require immediate contact with one’s doctor or an emergency room.  This is enough to get the point across, right?

Brain Chemistry and the Autistic Child – Consider This!

In my blog regarding chemical exposures affecting brain health it bears consideration that our young one’s brains don’t finish developing until they are 25.   Here is a quote from a book that jumps right off the page.  It speaks to the effects from antipsychotic drugs on the brain and I believe this comment from the book Your Drug May Be Your Problem says quite allot:

“Neuroleptics have their main impact by blunting the highest functions of the brain in the frontal lobes and the closely connected basal ganglia. They can also impair the reticular activating or ‘energising’ system of the brain. These impairments result in relative degrees of apathy, indifference, emotional blandness, conformity, and submissiveness, as well as a reduction in all verbalisations, including complaints and protests. It is no exaggeration to call this effect a chemical lobotomy.” – Peter Breggin and David Cohen, Your Drug May Be Your Problem, p. 77.

I find this very troubling. We don’t want our children to be ‘bland’ emotionally and ‘submissive’ because that would open them up to possible abuse from bullies or worse.  Our special needs children are already having trouble with communication, “verbalisations” as they call it, and experiencing a reduction in language capacity from a drug simply isn’t reasonable.

It isn’t to me.  Would you not agree that it is even more so an issue for our autistic children?  Why I would even venture to say it’s terribly unkind.  The words these authors used was that the use of this drug essentially is a “chemical lobotomy”.

Oh my, that is just the opposite of what we are trying to accomplish in helping our children grow into fully functional and capable adults, able to be all that they can be!!!

With that in mind now here is ….

 A Very Sad Story…Uh Humm, FACTS

There is a very sad history behind Risperdal.  What has surfaced in my research is that there are a number of lawsuits involving Risperdal starting as far back as 2012.  Before it was approved for use with children it was being promoted by its manufacturer for use as an antipsychotic for things like schizophrenia and bipolar conditions, first in adults, then in kids.  Then in time it began to be used to manage the irritability characteristics in autistic disorders.

The pharmaceutical company, Johnson and Johnson which is the parent company of Janssen Pharmaceuticals that manufactures Risperdal actually promoted use in children to the medical and clinical communities before it was approved

A Good Doctor is a Treasure...One Who Listens to Us and Finds Ways to Honor Our Decisions

A Good Doctor is a Treasure…One Who Listens to Us and Finds Ways to Honor Our Decisions

for children.  And doctors were just following recommendations made to them by big-pharma and started prescribing the drug for children.

A 16 page drug insert dated April 2014 summarizes numerous concerns for the elderly, adults, and adolescents.  I have only studied those sections that apply to our concerns, so no I haven’t read the entire insert.  I was most interested in the side effects for autistic children and that’s where I focused my attention.

There are studies going as far back as 1999 demonstrating a significant problem existed for children prescribed Risperdal.  In 2006 the Journal of Clinical Phsychopharmacology presented evidence that adolescents taking Risperdal were experiencing elevated levels of the hormone prolactin.  These elevated hormone levels in many cases resulted in gnecomastia, a condition of enlarged breast tissue that was often found to lactate, produce milk.  Another medical study in 2009 showed that the prolactin stayed in a child’s system for two years after suspending the drug’s use.

What’s the Problem with Prolactin?

For a lactating mom it’s a very good thing.  But for a young boy or young man it’s a big problem because an increase of this hormone causes young men to develop breast tissue and to even produce milk.  The breast tissue remains even though the drug is stopped.  And the only way to correct this abnormal tissue development in a boy is with surgery, a masectomy.   How totally demoralizing for our young men or boys to have to go through this!

Happy and Well-balanced...Our Ultimate Goal

Happy and Well-balanced…Our Ultimate Goal

I don’t know about you, but I am guessing that the FDA’s approval of this drug is questionable.  I haven’t drilled down on how many other studies are out there providing this substantive evidence.  But because more boys are diagnosed with autism then girls there is certainly going to be a higher incidence of this condition, medically called, gynecomastia.

In Canada a health and drug resource site, (chealth.canoe.ca) under the caption Other Precautions and Warnings for Risperdal stated regarding children and adolescents: “The safety and effectiveness of risperidone have not been established for use by children and adolescents under 18 years of age.”

Here is a notice from the Food and Drug Administration regarding a settlement reached with Janssen Pharmaceuticals. I think it’s an eye opener.  After all, they are paying 1.6 billion to cover costs regarding their misrepresentation of their drug. Makes one wonder why in the world it’s still made available especially for children.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373499.htm

Are You Bugged Yet?

Is this bugging you as much as it bugs me?  Surely having a child who is aggressive and ‘acts out’ creates a tremendous strain on the family and/or caretakers.  Under what circumstances would you seriously consider introducing this drug protocol for your child?  The fact that they can put on allot of weight, become diabetic, have their hormones kicked out of balance to the point that girls will prematurely develop and that boys will develop lactating breasts seems to me to be more mentally and physically damaging than the possible good that would come from the drug’s use.  Do you agree that we need to ask ourselves what is the purpose behind the drug for my child?  Do we need to perhaps integrate other resources that can help our irritable child?

Irritable? How many times have you seen this look?

Irritable? How many times have you seen this look?

 

Happy and Confident? Certainly Our Best Outcome!

Happy and Confident? Certainly Our Best Outcome!

 

You can Google ‘Risperdal lawsuits’ and you will find numerous law agencies seeking the business of family members or the patients that have been subject to these very negative side effects.  It is quite eye opening.  Here are two site urls that I felt had provided sufficient documentation and information to help folks address their concerns or possibly pursue litigation for the negative health effects.

http://sfari.org/news-and-opinion/news/2014/risperidone-use-in-children-with-autism-carries-heavy-risks

 

 

 

Should you want to read more about the issues that have now turned into many lawsuits you may want to read this entire reference from the website Drug Dangers.

http://www.drugdangers.com/risperdal/marketing-to-children.htm

Or this reference from another site that is engaging in the lawsuit fever over Risperdal.

http://www.forthepeople.com/class-action-lawyers/risperdal-lawsuits

One has to ask, what is the drug intended to do?  And is use of this drug in my child’s health worth the risk?  What do you think?  

Have you had to weigh the risks with the possible good this drug is supposed to accomplish?

Please share your story with us or comment below.

I would really appreciate hearing from you!

Some of My Research References

Here are some citations that I have used for some of my research for today’s blog.  I have gone to the Janssen website, downloaded the drug insert, sought information from health agencies like the FDA and Health Canada, and read up on the litigation.  If you have any questions about these or something you have read or disagree with leave me a comment below or contact me here.

Conley, Robert R. (2000). Risperidone Side Effects. Journal of Clinical Psychiatry. Accessed on 23 July 2014.  http://www.researchgate.net/publication/12507081_Risperidone_side_effects/file/3deec5195fdeb9983d.pdf

Cookson, J., et al. (May 2012) Prolactin, hyperprolactinemia and antipsychotic treatment: a review and lessons for treatment of early psychosis.  Journal of Psychopharmacology. Accessed on 23 July 2014. http://www.ncbi.nlm.nih.gov/pubmed/22472310#

Feeley, J.,Fisk, M. (10 September 2012). J&J Settles Risperdal Lawsuit on Opening Day of Trial. Bloomberg. Accessed on 23 July 2014  http://www.bloomberg.com/news/2012-09-10/j-j-settles-risperdal-lawsuit-on-opening-day-of-trial.html

Food and Drug Administration. (2011). Risperdal package insert. U. S. Food and Drug Administration. Accessed on 23 July 2014  http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf

Harris, G. (2008, November 18). Use of antipsychotics in children is criticized. The New York Times. Accessed on 23 July 2014 http://www.nytimes.com/

Holzer, L., Eap, C. (April 2006). Risperidone-induced symptomatic hyperprolactinaemia in adolescents. Journal of Clinical Psychopharmacology.  http://www.ncbi.nlm.nih.gov/pubmed/16633146

Johnson & Johnson. (2007-2013). Johnson & Johnson Investor Relations. Accessed on 23 July 2014 http://www.investor.jnj.com/sales-earnings.cfm

Maguire, GA. (2002).Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. Journal of Clinical Psychiatry. Accessed on 23 July 2014.  http://www.jclinpsychiatry.com/pcc/pccpdf/v04s02/v63s0408.pdf

MNT. (04 April 2013). Effects On Self-Esteem And Social Functioning Support Early Intervention And Treatment Of Boys With Gynecomastia. Medical News Today. Accessed on 23 July 2014.   http://www.medicalnewstoday.com/releases/258548.php

National Alliance on Mental Illness. (2014). Medications, Risperdal (risperidone). Accessed on 23 July 2014. http://www.nami.org/Template.cfmSection=About_Medications&Template=/TaggedPage/TaggedPageDisplay.cfm&TPLID=51&ContentID=20703

Rockoff, Jonathan. (9 May2013). J&J Balks on Deal to Settle U.S. Probe. The Wall Street Journal. Accessed on 23 July 2014 http://online.wsj.com/news/articles/SB10001424127887323744604578473211671818722

Silverman, E. (11 September 2012) J&J Sees Male Breasts And Quickly Settles Risperdal Suit. Forbes. Accessed on 23 July 2014 http://www.forbes.com/sites/edsilverman/2012/09/11/jj-sees-male-breasts-and-quickly-settles-risperdal-suit/

Taylor, DM (2003). Antipsychotics and QT prolongation. Acta Psychiatrica Scandinavica. Accessed on 23 July 2014. http://onlinelibrary.wiley.com/doi/10.1034/j.1600-0447.2003.02078.x/full

WebMD. (2014) Drugs & Medications – Risperdol Oral. Side Effects. Accessed on 23 July 2014. http://www.webmd.com/drugs/drug-9846-Risperdal+Oral.aspx?drugid=9846&drugname=Risperdal+Oral&pagenumber=6

 

So, folks, this has been a long post today, but it was a subject that deserved to be adequately addressed.  It is a touchy subject making a choice to use a recommended drug, especially when there are problems for the child.  Untreated irritability will permeate an entire day, and if the child is also terribly ‘disorganized’ and struggling with maintaining composure, that is hard on them too.  This is not a decision we can make lightly.  I hope this information has been helpful.  Please do let me know if you have questions or ‘ring my bell’ if you feel it is necessary.

Contact Me Here!

Or leave your comment on this page.

Drop Us a Comment! Or Share Your Story. We Will All Benefit From Your Generosity.

Drop Us a Comment! Or Share Your Story. We Will All Benefit From Your Generosity.

 

 

Kind Regards,

10 Responses to “Risperdal Long Term Side Effects

  • Hi Linda. I have heard of the drug Risperdal before, but never knew much about it until reading your article. It is hard to believe that the pharmaceutical companies would call it safe before it is even approved. I would think that the last thing a parent or grandparent would want for their autistic loved one is to be giving them more medications. This is a serious issue and I enjoyed reading such an informative post.

    • admin

      Hello Michelle,

      Its wonderful that you found value in my blog post about Risperdal. I put it up because a young woman I knew was being faced with a doctor pushing her to put her son on this drug and she knew about the side effect of breast development and was refusing. We all know that we have the final say where our children’s health is concerned so I found it irreprehensible that the doctor would be trying to force it on their family instead of respecting their wishes. It promoted me to do some research.

      The drug is now one of two drugs that are approved for autistic children. But back around 2007 and 2009 doctors were prescribing it based on a letter they’d received from the pharmaceutical giant when it was approved for adult use but at that time NOT for children. Even still, today it continues to have the side effects which is reason enough, at least for me, to not add it into the tools for caring for our young children. In my years of studying health what I came to feel is that any pharmaceutical is a synthetic man-made chemical composition intended to create a certain bodily response. It isn’t good enough when its synthetic, not natural and often has several other bodily responses, ie. side effects. Go figure.

      Thank you for the time you gave me for dropping into my website. I hope if you found something of value you will be able to share it with others to their benefit.

      Linda

  • Hi there. Just wanted to say thank you for a very kind, considerate post. It was really helpful to find this site and read through. I found a lot of support and information here, which I’m very grateful for. With so much to think about when considering medication, it is far from an easy decision. Articles such as this with so many references and supporting documentation are enormous sources of help! Many, many thanks. Jamie.

    • Linda

      You are oh so very welcome! I feel strongly that parents, grandparents, and other concerned family members deserve knowing all of the details of such an important decision. I am very grateful that you feel there is something of value for you and that you found my presentation of the information to kind and considerate. That is very encouraging to me.

      If you have any further questions, or want to run something else by me for research, please do let me know.

      Linda

  • What a very emotional read. I glad I now know of the side effects of risperdal and what i should expect in the case that one of my family members were to go it. This article was very hard to read and i do agree that you are very blessed that you have never had to be on this drug, however with all this negativity how is this medication still being sold? i wish you would explain that a bit more.

    • Linda

      Hello Anthony,

      I agree that this is a very emotional subject but I am glad you have found my post and will now have more information at your fingertips for making the decisions you feel are best for your family.

      It makes me very sad to say that the answer to your question about “how is this medication still being sold?” is enough to make one pretty darn angry. While I don’t have the figures at my fingertips right now, what I know to be the case is this….its the money. This drug like so many others makes money for the drug manufacturers. That is the bottom line, their bottom line would be affected if the drug were pulled from the market, and that’s even with the lawsuits that are being waged in court.

      This is my brief answer to your question. I can find figures for you, but the most important thing to remember is the drug is on the market, is still being prescribed because it is making the drug company money! That’s it, plain and simple.

      Let me know if there is anything else I can help you with. Thank you for coming by and reading my post. I hope you have passed it on or will pass this word on to those who might need to know.

      Linda

  • Geez I had no idea Risperdal could have such bad side effects. This is really scary stuff.
    I totally agree with you that very often medication for medical problems (and mental disorders) can often do more bad than good.
    I had no idea Risperdal was being used for Bipolar Disorder… I am Bipolar and hoping to go off my meds at some stage.
    Thank you for bringing to light these issues with Risperdal, I really think doctors are too quick to medicate, this is with normal run of the mill things like flu as well as much more serious things like mental disorders, autism and various other ailments.

    • Linda

      Hello Lynne.

      It is a very sad state of affairs that over the years the pharmaceutical industry has gained a great deal of power, power even to affect our personal choices. Many years ago my interest in health and the food and drug industry was piqued from a book I’d read titled “Innocent Casualties” by Elaine Feur. It infuriated me!

      Things haven’t gotten any better, in fact, I believe it is much much worse. The example of what’s going on with the flu vaccine only begins to scratch the surface of how severe the concerns are. I wrote about my research on the flu vaccine in this post from October, titled “http://specialneedsadvocatepower.com/serious-flu-s…“. I hope you will read it too. It is an eye opener!

      You make a good point that doctors are too quick to medicate! If we help a few “see the light” about this then there will be a few more that can reach out to help others and hopefully we can prevent some more of the sorrow that does occur, even tragedies.

      I wish you well with getting off of your meds. If done thoughtfully, providing your body with ways it can begin to rebalance itself, interestingly often times nutrition is a key factor, then you should be fine. Please if I can answer any questions or research something for you, do let me know.

      Linda

  • Thanks, that is really scary. I never knew that Risperdal had so many side effects. I am happy you created this post about those side effects. Because people should know since I think there are a lot more people who are totally unaware of these side effects.

    Are there any other products I have to be aware of ?

    Thanks

    • Linda

      Yes, indeed, many folks trust their doctors and do what they recommend. It saddens me that so many families and worse yet children are negatively affected by a prescription that has serious and emotionally damaging side effects. The lawsuits are justified!

      So glad you found value in the information.

      And YES, there are other meds, even vaccinations are of concern, so many that it makes my head spin. If you want to check out my post on the flu vaccine I think it gives some food for thought. Here is is: http://specialneedsadvocatepower.com/serious-flu-shot-side-effects-should-you-be-concerned-for-your-special-needs-children

      Please do pass this information or the one about the flu vaccine too. I know there are families that would benefit from having access to this critical health information.

      Linda

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