Wednesday, January 16, 2013


Okay,  here it goes.... I have to bring up something that I had to put aside for a few years.  Singulair allergy medicine.  Many of you are already familiar with my story.  If you know me, I am forward and honest regarding things that are important to me.  Especially regarding things that affect my children.  Yesterday my friend called to tell me that her pediatrician had prescribed Singulair allergy medicine for her five year old son.  She also told me that the pediatrician did not take the time to mention any of the serious (now well documented) side effects of Singulair.  After hearing this, I felt a very familiar and painful tug in my stomach as I thought back five years ago to a time when Singulair changed my daughter's life (and not for the better).   Rather then retell this story, I am simply including a series of emails.  Starting with an email that I sent to Sarah Sellers, a Safety Evaluator with the FDA.

Sent: Tuesday, May 06, 2008 1:55 AM
To: Sellers, Sarah
Subject: Singulair side-effects

Dear Dr. Sellers,

Please find below two paragraphs that detail my eight year old daughter's experience while taking Singulair for the past two years.  I wrote the first in preparation to submit a complaint against Singulair with the FDA.  The second was a post I recently  made on the web site
I am a "stay-at-home" mother of four.  My BA is in psychology and my husband also has a BA in business administration. We are financially stable and have provided a loving, happy home for our children.  I add these details simply to give a back ground and hopefully credibility to our story.  I have been shocked and outraged by the dismissive responses so many families have received from their medical care providers when they have questioned the side-effects of Singulair.  I continue each day to witness my daughter feeling healthy and happy again since discontinuing her Singulair on March 29th of this year.  Unlike Merck, I do not have the resources  to share my story with millions.  I implore you to listen to the families of the children that have suffered the most horrible side-effects of this drug.

Approximately two years ago my daughter was put on Singulair by her pediatrician to treat allergies.  Shortly after this time she developed leg pain that was debilitating enough to force her to withdraw from the dance class she was taking.  The leg pain persisted and eventually I was referred to an orthopedic specialist who diagnosed the problem as '"growing pains".  During this time my daughter also developed stomach pain.  After several visits to her pediatrician and subsequent visits to two different pediatric GI doctors,  the cause for the pain was still undiagnosed.  My daughter, who before Singulair was a happy, energetic child graduallly became very unhappy and seemingly unhealthy.  She began to suffer from constant fatigue.  She became angry and sad and suffered from severe crying spells.  She began to have an extremely poor appetite and often would refuse to eat completely.  She also developed severe insomnia and would wake in the morning upset and angry the majority of the time. These symptoms have continued for the past two years.  In early March of this year, 2008, I contacted my pediatrician and requested to meet with him.  I wanted to find out if there were any tests not previously performed on my daughter to determine what could be physically wrong.  In response to my request, my doctor recommended that I take my daughter to a psychiatrist.  On March 28th a friend sent me an e-mail describing recently reported adverse side-effects of Singulair.  I was shocked to read the similarities between my daughter's symptoms and other parents descriptions of their children's side -effects while taking Singulair.  On March 29th I stopped giving my daughter Singulair.  As of today, April, 15th, 2008 I have witnessed unbelievable changes in my daughter's health and behavior.  Within 3 days of being without Singulair her appetite began to return.  She is able to go to sleep and night.  She is smiling and laughing again and her normal energy level has returned... in summary, she has returned to herself again.  

May 1th
2:31 AM
After visiting this web site everyday for the past four weeks, I feel the need to share my daughter's (and my families') experience with singulair. My 8 year old daughter was put on singulair aprx. 2 years ago in addition to zyrtec to treat her allergies. Shortly after starting the drug, she developed stomach pain. After a few weeks of chronic pain, I pursued help from our pediatrician. After visits to two different pediatric GI doctors, an allergist (to test for food allergies), and an orthopedic surgeon ( because of sudden leg pain), the results were inconclusive. During this time my daughter also became very sad, angry and fatigued. She also completely lost her appetite and refused to eat much of the time. I attributed all of these symptoms to her stomach pain . In addition, she developed difficult sleep patterns and would often wake-up exhausted in the morning. Over time she also began to have more and more "melt-downs", breaking into crying spells over the smallest provocation or challenge. I recently contacted my daughters pediatrician to discuss what other testing or direction we could take to help my daughter. In the interim of making that contact, a friend told me about this web site. As I read page after page of other parent's experiences, I was in tears. I felt as if I was reading about my own family for the past two years. I say "family" because when one child is living through this kind trauma, everyone in the family is negatively affected in some way. My husband and I felt completely frustrated and unable to help our daughter. Our older children began to resent the great amount of time and energy I spent on behalf of our daughter. My younger daughter who had always looked up to and loved her older sister was sad and confused by her sister's anger and impatience.On March 29th I took my daughter off singulair. Unbelievable. Within 3 days, my daughter's appetite returned. On the second day, she came home from school and requested a corn dog and then some ice cream. She suddenly wanted to eat breakfast again. She started smiling and laughing again. She has suddenly become capable and responsible for doing her homework and chores. She is going to sleep more quickly and waking up happy. The best part is having our daughter back...the sweet, wonderful, happy six year old who I feel like I lost for two years of her life! As a side note-the return call I got from my pediatrician was that he wanted my daughter to see a psychiatrist. That's how close we were to taking another (completely unnecessary) path to helping my daughter. I also recently spoke with my daughter's allergist about our experience. At first he was somewhat dismissive. I asked him to listen to me parent, to parent for just a moment. He seemed to soften and said he would take a second look at singulair and its side effects. I encourage every parent who's child has been so adversely affected by this drug to be proactive. First, please contact the FDA to report your experience. Second, talk to your children's physicians and share, with confidence your experience. Third, share this web site or a similar one with everyone you know. I have been astounded how many children are on singulair just within my own small circle (school, church and play group). I really believe one voice can make a difference. I have to believe that for the sake of all the children still suffering.May 1th

Dear Terra,
Thank you for taking the time to contact me regarding your daughter's experience while taking montelukast.  You mention that your child was also prescribed Zyrtec--was this medication discontinued at the same time as montelukast (Singulair) or is it something that she continues to take?  Clarification on this point would be helpful. Also, you indicate that you were preparing to submit a report to FDA through the MedWatch system.  If you haven't already, I would encourage you to do this if it is not too much trouble, being as specific as possible regarding past medical history, when the medication(s) were started, when symptoms emerged, when drug(s) were discontinued and what happened subsequently.  The report can be submitted on-line at
Please be assured that the information you have provided will be considered in our review of this concern.
Sarah Sellers
Sarah Sellers PharmD MPH
Safety Evaluator
Division of Adverse Events Analysis I
Office of Surveillance and Epidemiology
Food and Drug Administration

Sent: Tuesday, May 06, 2008 12:16 PM
To: Sellers, Sarah
Subject: Re: Singulair side-effects

Dear Dr. Sellers,
        Thank you for responding so quickly to my e-mail.  I discontinued giving my daughter Zyrtec approximately six weeks after starting her on the Singulair.  I wanted to see how this would effect her allergies.  The Singulair itself seemed to control the allergies (ironically),  so I never started her back on the Zyrtec.  I think its important to note from a "scientific" perspective that the only variable that has changed in my daughter's life recently has been the discontinuation of the Singulair (as mentioned on 3-29-08).  Also, as mentioned, the changes have been remarkable.  I am in the process of trying to interpret her medical records at this time and hope to be able to submit the results to the FDA sometime this week.  Again, I want to express my most sincere gratitude for responding to my e-mail and taking the time to review our information.



So, dear readers, there it is.  I have one simple request of all medical professional who are in a position to prescribe Singulair.  PLEASE, inform parents about possible side effects!!! If you are too busy to verbalize them specifically, PLEASE, express to the parents the importance of reading about the side effects after filling the prescription.  And YES, as parents, it is our responsibility to read those about those side effects.   But, I trusted my pediatrician and trusted his judgement.  If I had known what to look for, I would have made the association between my daughter's behavior and the medication immediately.  Unfortunately, it took me two years.  As a side note....after our pediatrician became aware of my daughter's situation (keep in mind he wanted to refer her to a psychiatrist), he stopped prescribing Singulair all together.
Okay, I feel better now.  Thank you for listening.  Moms,  please pass this info on....Singulair is one of the most widely prescribed drugs for children under seventeen.

Oh....and some additional reading if you'd like more info...
Asthma Drug Gets New Labeling Singulair Side Effects

* And I promise, my next blog post will be a lighter!