Singulair Black Box

From comments:

Hi I just found your blog while doing endless searches on pediatric asthma. I have a few questions for you if you don't mind. What is the Singulair black box warning, is it about depression/ suicide? And I also had a question about your personal experience with flovent. My son has just been prescribed it, and he is two. Have you noticed any growth supression, and have you noticed any serious behavioral changes? I am so worried about giving him this drug, and the doctor and pharm just try to play down the side effects, but when I search online I find LOADS of unhappy mothers about them! Thanks for your posts!

First of all, your welcome! I'm so glad you find my blog helpful. Regarding Flovent - we never noticed any behavioral changes, but we actually did see suppression of growth. #1 son was pretty tiny when we took him off the stuff, and probably shot up a foot over that summer. He's grown astronomically since then. It's hard to say how much of that was just natural though.

What I can tell you about Flovent is that once he started it, we never had to go to the emergency room again. We haven't had any hospitalizations for any of our kids since we started them on Flovent. We don't love that they've been on steroids for years, but the results are well worth it for us. If you look through the comments on this blog, I think you'll find that *most* readers agree

As for Singulair - yes, there was a concern about Singulair causing suicidal thoughts and other behavioral problems. Our pulmonologist promptly yanked my kids off the stuff as soon as the warning was issued, despite the fact that none of them ever experienced side effects of any kind. (I do appreciate her caution though!)

As far as I know via my very quick research, Singulair has never been black-boxed, although many consumers seem to be pushing for this.

As recently as June 2009, Merck has been pushing back against the FDA on the basis that Singulair has proven to be incredibly helpful to many asthma and allergy patients.

Merck is confident in the efficacy and safety of SINGULAIR, a medicine that has been prescribed to tens of millions of patients with asthma and allergic rhinitis since its approval more than 11 years ago.

"For the millions of people suffering from either asthma or allergic rhinitis, SINGULAIR is an important treatment option for appropriate patients," said Scott Korn, M.D., vice president, Clinical Risk Management and Safety Surveillance, Merck Research Laboratories.

SINGULAIR is indicated for the prevention and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children 2 years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children 6 months and older. The efficacy and safety profile of SINGULAIR is supported by available data from controlled clinical trials, in which more than 20,000 patients received SINGULAIR, and from a review of post-marketing adverse event reports collected since the drug was approved by the FDA. ...

In clinical studies in patients with asthma, adverse events were generally mild and varied by age. The most common adverse events in clinical trials in adults and adolescents with asthma ages 15 years and older were headache, influenza, abdominal pain, cough and dyspepsia. In clinical studies in patients with allergic rhinitis, SINGULAIR was generally well tolerated with a safety profile similar to placebo. The most common adverse events in these clinical trials included sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased alanine aminotransferase (ALT). Less common side effects that have happened with SINGULAIR include behavior and mood related changes [agitation including aggressive behavior, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, suicidal thoughts and actions (including suicide), tremor, trouble sleeping].

On August 28, the FDA updated its page regarding the review of Singulair and similar drugs. Regarding the status of this review, the FDA now recommends that:

Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.

Patients should talk with their healthcare providers if these events occur.

Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

I don't know if this is FDA code for "Black Box" - anyone?

Behavioral issues from Pulmicort and Singulair?

Another comment to address:

My son is on singulair and plumicort. He has had "asthma/breathing" problems since he was six months old. He was put on the meds the summer bw pre-k and kindergarten. He was a perfect student in Pre-k, but ever since he has been in trouble in school. He just started the first grade and his teacher has asked me to have him tested for ADHD. I do not want to medicate him anymore than I have to. I have read that singulair and plumicort can have these side effects on children. But he needs them to survive!! The dr told me today I can take him off the singulair for a week and see if there is a difference.

So, keep in mind that Singular and Pulmicort absolutely CAN cause behavioral side effects...but they don't always. We were fortunate enough to never see those side effects (I assume, but I've never been able to talk Ozzy off the stuff!), although we did have others. We did see jumpiness from Albuterol and Prednisone, but not from the maintenance meds.

I would follow your teacher's advice. Talk to your pediatrician about your teacher's report and try to understand if her concerns seem related to the medications. Talk to your pulminologist if he or she might have a better understanding of the side effects. If your pediatrician thinks it's warranted, take your son for the evaluation. If your behavorial psychologists and/or pediatric neurologists handle evaluations in a manner similar to the way our doctors do, you'll find the evaluation an enlightening experience. My kids and I have actually enjoyed those appointments, believe it or not.

And if your child does have ADHD, you'll be able to get the treatment he needs. Not all doctors medicate for it - and not all kids require medication. (Our Ig was recently diagnosed with PDD-NOS, and I was warned that he probably has ADHD as well, although he's too young to diagnose. Like you, I don't want to medicate. I don't like those meds! If we have to do it, we will, but we'll do everything we can to avoid it.)

So, in summary, do the evaluation. Your child's classroom issues may not have anything to do with the asthma meds. But once you have a diagnosis (or not), you'll be able to make informed decisions about how to help your child succeed in and out of the classroom.

Good luck - and please keep me posted.

H1N1 - and all flu - require vigilance

Have to adress this comment that came in as a response to my swine flu post from July:

No offense, but it seems very unwise to say H1N1 is no big deal and then make an offhand remark at the end of your post that your child was on an anti-viral medication. And it's possible that the negative flu test was indeed accurate, and it was not the flu. This response is written in September after the resurgence of the flu and I believe it is has to be taken seriously. According to the CDC, 30% of the children who have died from H1N1 had no pre-exisiting health condition. It has been proven that young people and children with asthma are at particular risk. This flu has the ability to penetrate deep into the lungs and replicate there, unlike the "regular" seasonal flu. This was suspected at first (shown in animal testing) and confirmed by testing done at the CDC. This explains why it is causing pneumonia in some people who wouldn't normally get it form the flu. For most people it WILL be a relatively mild illness but no one yet truly understands this new virus - all parents of children with asthma should remain educated and vigilant.

Defensively, I have to make to comments (and yes, I know it's stupid for me to get defensive):

First: Do you remember they hype around H1N1 in June and July? At that point, the virus was affecting far fewer people than a typical seasonal flu outbreak - and with far fewer serious and fatal cases - yet the media was treating it like we were amidst an outbreak of bubonic plague.

If I seemed to have been taking things lightly, it's only because it was only because the flu we had was shockingly mild.

Secondly, my kids were WELL into the their flu by the time they started antivirals. I would say they were already "over the hump."

That said, we NEVER take the flu lightly, and I apologize if I seemed offensively flippant. We've had enough chest X-rays, Prednisone, round-the-clock nebs and hospitalizations to last a LIFETIME, believe me!

We will vaccinate (thimerosal-free, cause I'm weird like that) when possible, and we'll see the doctor at the first sign of anything. We'll keep our hand-washing up, and, like any responsible mother, I will keep my kids home if they seem sick. I hope you'll do the same.

I actually haven't been keeping up with the state of the flu so well... If you have updates on stats and symptoms, please share.