FDA MedWatch- Singulair (montelukast)- ?Assoc.to Behavior/Mood Changes, Suicidal

[Guest guest]

From the Occ-Env-Med board.

From: U.S. Food & Drug Administration (FDA)

<fda@...>

Date: Thu, Mar 27, 2008 at 11:52 AM

FDA informed healthcare professionals and patients of the Agency's

investigation of the possible association between the use of

Singulair

and behavior/mood changes, suicidality (suicidal thinking and

behavior) and suicide. Singulair is a leukotriene receptor antagonist

used to treat asthma and the symptoms of allergic rhinitis, and to

prevent exercise-induced asthma. Patients should not stop taking

Singulair before talking to their doctor if they have questions about

the new information. Healthcare professionals and caregivers should

monitor patients taking Singulair for suicidality (suicidal thinking

and behavior) and changes in behavior and mood.

This early communication is in keeping with FDA's commitment to

inform

the public about its ongoing safety reviews of drugs. 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.

Read the complete 2008 MedWatch Safety Summary, including a link to

the FDA Early Communication About An Ongoing Safety Review regarding

this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair

________________________________

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

[Guest guest]

Hi KC,

I saw this earlier today. I am on Singulair and it is

a wonder drug for me. There are times an inhaler does

no do the trick all of the way but Singular does. I

have not been sucidial but I do have bouts of

depression while on the drug. I am now wondering if

it was the Singulair. I am going to cut back on it

and see how I feel.

Anyway, there might be something to this.

Jackie

--- tigerpaw2c <tigerpaw2c@...> wrote:

> From the Occ-Env-Med board.

>

> From: U.S. Food & Drug Administration (FDA)

> <fda@...>

> Date: Thu, Mar 27, 2008 at 11:52 AM

>

> FDA informed healthcare professionals and patients

> of the Agency's

> investigation of the possible association between

> the use of

> Singulair

> and behavior/mood changes, suicidality (suicidal

> thinking and

> behavior) and suicide. Singulair is a leukotriene

> receptor antagonist

> used to treat asthma and the symptoms of allergic

> rhinitis, and to

> prevent exercise-induced asthma. Patients should not

> stop taking

> Singulair before talking to their doctor if they

> have questions about

> the new information. Healthcare professionals and

> caregivers should

> monitor patients taking Singulair for suicidality

> (suicidal thinking

> and behavior) and changes in behavior and mood.

>

> This early communication is in keeping with FDA's

> commitment to

> inform

> the public about its ongoing safety reviews of

> drugs. 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.

>

> Read the complete 2008 MedWatch Safety Summary,

> including a link to

> the FDA Early Communication About An Ongoing Safety

> Review regarding

> this issue at:

>

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair

> ________________________________

>

> 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

>

>

>

________________________________________________________________________________\

____

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