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Time to take the Singulair question to a doctor

Submitted by on Sunday, 14 June 2009 4 Comments

I partially bought the drug-company spin on Singulair in January largely because I wanted to:

The Food and Drug Administration found no link between the popular asthma drug and increased suicide risk, which led manufacturer Merck to proclaim itself “pleased with the conclusions.”

I did note at the time, though, that the FDA would continue studying the popular asthma medication for links to “other behavioral and mood events.”

I’d heard from other parents that they’d seen dramatic improvement in their young children’s behavior after discontinuing Singulair, a medication Big Guy’s taken since he was 15 months old.

A medication that controls his asthma perfectly – he’s had only one serious attack in almost six years, and that was during a period of heavy wildfires that left the sky tan for days.

Yet, I wondered. Was it merely a mercurial nature responsible for tantrums that seemed far more fiery than those of peers his age? Or was it something else? Was the same medicine that was saving his lungs torturing his mind? That’s hard enough for an adult to deal with. It would be positively cruel for a child.

I decided to wait until after the FDA finished its studies.

That happened last week, and it isn’t pretty.

The analysis turned up instances of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremors, the FDA news release said.

As a result, the agency wants manufacturers to revise labels for Singulair, Accolate and Zyflo to include a “precautionary statement” about those potential problems.

“Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications,” the release said.

Merck, of course, continues to be confident in the safety of Singulair, according to The Wall Street Journal. I bet Merck, which is not above faking entire medical journals, also was once confident in the safety of Vioxx.

Looks like I’ll be calling Big Guy’s allergist tomorrow for an appointment. I’d hoped to wait until I figured out where he’ll go to school next year so I could get his current doctor to fill out required forms before we move.

Friday’s announcement, though, puts the check-up into the “can’t wait” category for me.

Copyright 2009 Debra Legg. All rights reserved.

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  • Lisa said:

    Just because those can be side effects doesn’t they will be. If temper tantrums (which I have with my 5 year old daily) are your only issue, then I think you should probably keep him on (this is coming from someone who literally is allergic to life itself. I tested allergic to every single thing they tested me for). It is up to your allergist though and I wish you luck.

  • Leslie K. said:

    OH HECK! Well, I for one am going to put him at the top of my prayer list – I will find out who the patron saint of asthmatics is and then we will pray that this med (which has worked so well for him) continue to be ok, and not have ANY side effects!

  • Leslie K. said:

    It’s one of my faves: St Bernadette (played by the incomperable Jennifer Jones).

  • Debra said:

    Allergic to life itself – wow! That makes two of us, Lisa. I bet the doctors even scratched their heads and wondered if you were allergic to the needle when you came back with so many positives. Yep. Same here. Turns out, I wasn’t allergic to the needle, just everything that floats, flies, walks or swims. Who needs a perfect SAT score when you have perfect allergy test scores.

    I wasn’t able to get an allergist appointment until early July, but I do plan to run it past him to see his level of concern and check out alternatives. I’m just a little concerned given this particular manufacturers’ track record of trickery.

    Leslie, is there anything you can’t find a patron saint for? Is there one for “moms freaking out as they try to figure out where to move their kids so they don’t get an H bomb dropped on their education”? That’s my newest trauma.