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 asthmasymptoms2011.blogspot.com/" title="depression">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, asthmasymptoms2011.blogspot.com/" title="sinus headache">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, asthmasymptoms2011.blogspot.com/" title="depression">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?

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