Singulair - fyi
Moms View Message Board: General Discussion: Archive March 2008:
Singulair - fyi
I was surprised to read this today and thought I should pass it along.
http://www.usatoday.com/money/industries/health/2008-03-27-suicide-link_N.htm
and here is the article from the FDA's website.
Early Communication About an Ongoing Safety Review of Montelukast (Singulair)
This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.
Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).
In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).
FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.
Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
The FDA urges both healthcare professionals and patients to report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event Reporting program
on-line at [www.fda.gov/medwatch/report.htm];
by returning the postage-paid FDA form 3500 [available in PDF format at [www.fda.gov/medwatch/getforms.htm] to 5600 Fishers Lane, Rockville, MD 20852-9787;
faxing the form to 1-800-FDA-0178; or
by phone at 1-800-332-1088
I saw this on the news yesterday. My ds takes Singulair. But, he has been taking it for 3 yrs. with no side effects. Pretty scary though. We see his allergist in a few weeks, and I am going to talk to her about it.
My DD took Singulair for a short time last year, but it did nothing for her asthma/allergies. Our allergist said it only works for about 40% of his patients.
That said, DD was on Zrytec for a few weeks, and I noticed a definite negative change in behavior and moods. Our allergist said it does have that effect on some kids. Needless to say, I took her OFF it. She's on Allegra now and doing fine.
Singulair Article
No one on these meds at my house.
AMEN! Natalie took Singulair last year for allergies and turned into another child completely. It helped with her allergies, but she slept very little for nearly 2 weeks, yet never seemed very tired. She was hateful, grouchy, defiant, and just overall a different child. It took us at least a week to even consider that it was due to the new medicine she was on. It was a nightmare two weeks that's for sure. I think I may have posted about it here. She was a holy terror, and in a very mean way - just flat out defiance, attitude, and anger. She slept about 4 hours each night before being up the rest of the time. Then she would nap maybe an hour a day. I started reading online boards about this drug and read tons of other similar stories. I told her doctor and he seemed as if he'd never heard of these type of side effects before and recommended that we contact the company with our experiences. I had read enough online to know that we weren't the only ones.
She also had major sleeping issues with Allegra. Medically it also took care of her allergies but the side effects were terrible for her.
I think I remember your post from last year Deanna. I am glad you figured out it was the singulair.
It was such a relief to realize it was the Singulair. It took about 4-5 days of being off of it and she went back to normal. It was a real eye-opener to how one medication can really change the way a person behaves and functions everyday.
Count me as one who has seen negative side effects with Zyrtec, but none with Singulair. It just goes to show, you need to trust your doc, try what he/she prescribes and then wait and see.
Ame
I take Singulair, and last year it worked really well for me, this year, now at the height of allergy season, it doesn't seem to be working as well. However, I've noticed no side effects from it!
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