Couple discusses Singulair concerns with FDA

A Queensbury couple went to Washington, D.C. Friday to call for better warning labels on the popular asthma and allergy drug Singulair.

[P Smith]

Both of my sons (age 20 and 17) were on Singular since last fall. They both had what I thought was seasonal affective disorder this past winter--moderately severe depression. When I heard your story I took them off singular and had the doctor switch them to different allergy meds. They are both much happier and less nervous and depressed now, although the end of winter may be helping, too?

[Shawn Mileski]

My son had been on Singulair since the age of 5 and it was very effective at controlling his asthma symptoms. Shortly after he turned 8 (summer of 2006), he began having crying episodes every night before bed, but could not describe what was wrong. He could only say, "I don't feel like a kid anymore". He became quiet and withdrawn and could not sleep. Some of these crying episodes at bedtime lasted 2 or more hours. We tried everything- until one night I punched in "depression" and "singulair" on Google. It was a last grasp because the medicine had been working so well for him, but I had no idea what else to do. I couldn't believe the information that was posted by parents about their children (seemed to be mostly boys) and depression on Singulair. I made an appointment with my son's pediatrician the next day and explained what had been going on and what I had found. The pediatrician told me he had not heard of such a link, but agreed to allow us to stop the Singulair on a trial basis. We did not tell my son, and just pretended to 'forget' to give it to him. Within 2 days the crying episodes had completely stopped and he was sleping better at night. We scheduled an appointment with a counselor and by the time we got in to see him (several weeks later), my son was completely symptom free. The counselor saw him a few times and then discharged him with a dx of a medication side effect. It wasn't until I heard the awful news of the Miller's tragedy that I realized how pervasive this problem is and how little local pediatricians are aware of it. Thank you for spotlighting this very serious problem with a very popular medication. Prayers, love and strength to the Millers.

[Patricia Slavin]

I can relate to a drug reaction. In 1999 I was given Floxin for a bladder infection. I broke out in huge hives all over my body, had chills and headache. My throat closed and I went to the ER. However, the hives returned and I suffered with them for over 5 years. I was on Medrol (Prednisone all 5+ yrs. and my weight gres.). It was determined "finally" that I am allergic to Quinalin drugs.
I hope I never have to go through that again!

[James]

Shawn Mileski. Your son was on this drug for three years before he became quiet, withdrawn, and started having sleep problems? maybe it's not the drug that had helped him 3 yrs that is causing his anxiety, but maybe he's just experiencing the trials and tribulations of growing up in todays turbulent and stress filled world? Maybe his bounce back has something more to do with the support that he's recieving from his family than stopping a drug that has helped him and millions other?

James

[Shawn Mileski]

James,
I thought the same thing at first. This medication worked so well at treating his asthma symptoms that I really did not want to stop it. However, I feel very strongly that Singulair did trigger this episode for a number of reasons. The first being that the syptoms stopped completely almost immediatly after we discontinued the drug. Secondly, a trained clinician discharged my son from counseling stating that he had an adverse reaction to this medication.
I don't know why it took three years before he expreienced this side effect. I can guess that maybe as he grew, his body chemistry changed slightly or maybe the medication built up in his body. I really have no idea of how it physiologically happened, but I am sure Singulair triggered this reaction with him.
I know that millions of people have had great success with this medication, and that is wonderful. Like the Millers, however, I think more information about this possible side effect should be made available to treating physicians and their patients.

[saveCFCinhalersD OTorg]

James, Shawn's son had a positive response to what the FDA calls a "dechallenge" test- Singulair was discontinued, side effects went away (MANY have experienced this, by the way). What makes you think that Shawn's son received an iota less support from his family prior to the Singulair dechallenge test than afterwards? The placebo effect can also safely be ruled out- since there was no mention of their stopping the drug to their son.

Shawn could now try a Singulair "rechallenge" test without fanfare to see if the side effects come back, but I don't think they are going to subject their son to that. Nor should anyone expect them to.

Not to put too fine a point on it, anyone who carefully reads Shawn's letter can safely put your 'sudden increase in family support after Singulair dechallenge' theory in the 'absurd at first blush' category. Ditto the 'placebo effect' possibility. If Singulair is not to blame, that leaves sheer coincidence, James. Suit yourself.

There are many medical mysteries, James. Your question about why it took Shawn's son three years to develop this side effect to Singulair is one.

The question of why so many happy Singulair users dismiss a mountain of strong anecdotal evidence about Singulair's side effects for some (NOT ALL) patients is another such medical/psychological mystery.

I can't answer the first, although I am sure that Shawn is on the right track.

The second mystery is more easily explained. Many Singulair users are afraid that if these Singulair adverse events continue to come out- Singulair will be banned, and this explains their rage (not in you, James, but in many others on these threads) and their obvious desire to have the people, like the Millers, who publicize these side effects, JUST SHUT UP.

To everyone who is worried that Singulair will be banned: RELAX. IT WILL NOT HAPPEN. The warnings save lives, and are a vital 'heads-up', but they WILL NOT cause Singulair to be banned.

How do I know this? It's very simple.

On 12/31/08 the FDA ban on CFC Albuterol inhalers takes effect, and all inhaler users will be forced to use HFA inhalers.(Read the petition comments- the link is below- use the "signatures" button at the top of the petition- to see how well this is going over with some (NOT ALL) pulmonary patients. Read the MEDWATCH PDFs posted on the right side of the petition as well- we are in the process of updating these currently.)

When the ban takes effect, we believe that the FDA is going to endure The Mother of All Backlashes from MANY of the 35 million US pulmonary patients and their families who love CFC inhalers and HATE HFA inhalers, and they (the FDA) will be under severe attack from all directions.

In this environment, the idea that the FDA would even CONSIDER banning ANOTHER major asthma drug- Singulair- which is loved by many patients (including me, by the way) is beyond absurd. Such a ban would be politically untenable. You read it here first: Singulair will NEVER be banned.(But that doesn't mean that the side effects being discussed here should not be widely publicized-they should be- and the Miller's have done a HUGE public service by getting this story out).

Finally, at the risk of being accused of hijacking this thread, I am posting the link for the petition to SAVE CFC ASTHMA INHALERS for all of those who want to sign it and get added to our mailing list (our first email will go out no later than mid-June, probably earlier).

http://www.ipetitions.com/petition/saveCFCinh...

or google: "save cfc"

[James]

I can see how i may have come across a little blunt and insensitive--for that I do apologize... especially to Shawn. I truly hope for nothing but happiness and well being for all of us.
I am passionate about the enormous benefit that we have gained from modern medicine. The whole medical community has been under fire these days. Physicians, managed care, hospital boards, the makers of drugs and down the line.

-J

[Shawn Mileski]

No apology needed. This is a very important topic and any conversation around it is good.

[Kate and Dave Miller]

Hi Shawn,
I wanted to let you know that stories like yours keep us going.I also wanted to take the time to remind people to report their stories to medwatch.com , it is the official FDA website for reporting adverse events. I have an email address for the Safety Reviewer from the office of Surveillance and Epidemiology Division of Adverse Event Analysis.They want to talk to people who have witnessed the turn around after discontinuing the medication. If you want to contact me personally I am in the phone book under David and Kathy Miller Qsby.I am so very happy your son is fine and you have found peace with your conclusion.I would be very pleased to help you. Sincerely Kate

Shawn Mileski wrote:

My son had been on Singulair since the age of 5 and it was very effective at controlling his asthma symptoms. Shortly after he turned 8 (summer of 2006), he began having crying episodes every night before bed, but could not describe what was wrong. He could only say, "I don't feel like a kid anymore". He became quiet and withdrawn and could not sleep. Some of these crying episodes at bedtime lasted 2 or more hours. We tried everything- until one night I punched in "depression" and "singulair" on Google. It was a last grasp because the medicine had been working so well for him, but I had no idea what else to do. I couldn't believe the information that was posted by parents about their children (seemed to be mostly boys) and depression on Singulair. I made an appointment with my son's pediatrician the next day and explained what had been going on and what I had found. The pediatrician told me he had not heard of such a link, but agreed to allow us to stop the Singulair on a trial basis. We did not tell my son, and just pretended to 'forget' to give it to him. Within 2 days the crying episodes had completely stopped and he was sleping better at night. We scheduled an appointment with a counselor and by the time we got in to see him (several weeks later), my son was completely symptom free. The counselor saw him a few times and then discharged him with a dx of a medication side effect. It wasn't until I heard the awful news of the Miller's tragedy that I realized how pervasive this problem is and how little local pediatricians are aware of it. Thank you for spotlighting this very serious problem with a very popular medication. Prayers, love and strength to the Millers.

[Cherylyn]

James,

I have a son who is now five. He's been on Singulair since he was two years old. I've been noticing behavior changes with him as well and I've made an appointment with his allergy specialist because I believe this medication has something to do with it. I saw his normal pediatrician last month and asked him about depression associated with this medication and all he could say was, " Well he's not thirteen so we don't have to worry about suicidal thoughts yet. Let's continue the medication at least until he's older."
In my opinion... that's absurd. Just because at the age of five children don't typically think about suicide, does not mean that they won't have other thoughts stemmed from depression.

James wrote:

Shawn Mileski. Your son was on this drug for three years before he became quiet, withdrawn, and started having sleep problems? maybe it's not the drug that had helped him 3 yrs that is causing his anxiety, but maybe he's just experiencing the trials and tribulations of growing up in todays turbulent and stress filled world? Maybe his bounce back has something more to do with the support that he's recieving from his family than stopping a drug that has helped him and millions other?
James

[kittenn]

there are risks with EVERYTHING! We need to label LIFE!

[Rhianna Smith]

My son has come out of a completely different cycle from the medicine Singulair and thank you channel 13

[emac]

My son also has been on singulair for over a year. He is now 7 and the past month has been having horrific thoughts like "when is the world going to end?" or wishes he wasnt in this world. Hes suddenly anxious about death and everyone dying. Says cant get these thoughts out of his head and doesnt feel well.This behavior erratic and there is nothing I can say or do to comfort him. Total personality change. Are these questions a 7 year old has or could this be a side effect of this med? Its very scary

Shawn Mileski wrote:

My son had been on Singulair since the age of 5 and it was very effective at controlling his asthma symptoms. Shortly after he turned 8 (summer of 2006), he began having crying episodes every night before bed, but could not describe what was wrong. He could only say, "I don't feel like a kid anymore". He became quiet and withdrawn and could not sleep. Some of these crying episodes at bedtime lasted 2 or more hours. We tried everything- until one night I punched in "depression" and "singulair" on Google. It was a last grasp because the medicine had been working so well for him, but I had no idea what else to do. I couldn't believe the information that was posted by parents about their children (seemed to be mostly boys) and depression on Singulair. I made an appointment with my son's pediatrician the next day and explained what had been going on and what I had found. The pediatrician told me he had not heard of such a link, but agreed to allow us to stop the Singulair on a trial basis. We did not tell my son, and just pretended to 'forget' to give it to him. Within 2 days the crying episodes had completely stopped and he was sleping better at night. We scheduled an appointment with a counselor and by the time we got in to see him (several weeks later), my son was completely symptom free. The counselor saw him a few times and then discharged him with a dx of a medication side effect. It wasn't until I heard the awful news of the Miller's tragedy that I realized how pervasive this problem is and how little local pediatricians are aware of it. Thank you for spotlighting this very serious problem with a very popular medication. Prayers, love and strength to the Millers.