Monday, September 21, 2009

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?

1 comment:

Anonymous said...

I found your blog when doing a search, and i wanted to throw my two cents in, even though it's about a post from two years ago. I wanted to share with you my experiences with albuterol, xopenex, and prednisone.
I'm 18, and have had asthma for 11 years. I took Albuterol for the first 4 years with typical side effects- extreme jitters, fast heart rate, insomnia, etc.until i was 11, when i had a really severe attack and went to the hospital for the millionth time. I was given oral prednisone and threw up so violently i will never forget it. I threw up kidney bowls full of blood to the horror of the nurses. I was clearly allergic to the prednisone, but the doctors kept saying it was because i hadn't eaten enough, blah blah. After getting sick a handful of times, i was sent to the childrens hospital, had and endoscopy, and found out that i had torn my esophagus in two places. Long story short, prednisone... is not something i really care to take again, although i have taken the medrol dosepack of Methylprednisolone, which seems to work very well with no symptoms. I wish i hadn't been given it as an end all cure all at a young age. As a result, i stopped growing in middle school and am full grown at only 5 feet tall, and i have almost no immune system. If your children get prescribed it for short term dosing, by all means, it's wonderful. But i would hate to see them fall off the growth chart like i did due to it.
Also, during the aforementioned endoscopy, i was given an albuterol neb treatment since i was still sick and wheezy. I woke up in the post op room screaming. there's no way to describe the way my head felt. i was sobbing. After 4 years of working fine, the albuterol had given me the worst migraine of my life. I was switched to Xopenex and have been taking it for the past 7 years with no problem, at the .63mg dose first and now at the 1.25mg dose. It works wonders. i still have insomnia, i still have jitters, but it's really not as bad, and luckily, no allergy to it. After seeing a post you had from two years ago about Xopenex, and after i read the comments saying Xopenex is just albuterol in an expensive package, i felt like i had to say something. The extreme reaction i had to albuterol is not common, and can't be explained, but i'll keep taking Xopenex for the rest of my days, even if it is expensive.
Good luck with the management of your boys' asthma. Its good to know that i'm not the only person who was diagnosed at a young age, and that there are parents out there who are proactive in their child's care.