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FDA looking at Singular & Suicide


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#1 dalilavender

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Posted 28 March 2008 - 08:51 AM

Wow, this could be a very serious thing, considering the increased rates of asthma in teens and adults.

Quote

FDA probes suicide risk in Merck's Singulair
Thu Mar 27, 2008 1:57pm EDT
By Susan Heavey

WASHINGTON (Reuters) - U.S. health regulators are probing a possible connection between Merck & Co Inc's blockbuster Singulair asthma drug and suicidal behavior in adults and children, the Food and Drug Administration said on Thursday.

The FDA said it is reviewing the issue after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took the drug, which is used to treat stuffy nose, sneezing and other allergy symptoms, as well as asthma.

No definite link to the drug has been established and the agency did not say how many post-marketing reports it had received. Merck declined to say how many reports had been submitted, but said they involved both adults and children.

While Merck earlier noted the behavioral risk on Singulair's drug label, the FDA said it asked the company to evaluate its data for more information. The agency said its review would take up to nine months to complete.

In a statement, Merck said its analysis of more than 11,000 patients in 40 clinical trials found no reported suicides or suicidal thoughts or behavior. It added that it was working to inform doctors about the concerns with Singular, first approved in the United Stated in 1998.

The FDA said it is also reviewing reports of behavioral changes in patients taking similar drugs, including AstraZeneca Plc's Accolate and Critical Therapeutics Inc's Zyflo, but has not yet decided whether further investigation is needed.

All three drugs are known as leukotriene agents that work by controlling leukotrienes -- chemicals in the body that are released during an allergic reaction and can lead to inflammation, congestion and other symptoms.

Singulair is Merck's biggest selling product and one of the world's top selling medicines with 2007 global sales of $4.3 billion -- $3.4 billion in the Unites States.

In comparison, Accolate took in $57.4 million in U.S. sales in 2007, while Zyflo and Zyflo CR combined brought in about $10 million, according to data from IMS Health.

Some analysts said news of the FDA's probe was not likely to curb the use of Singulair, which saw little impact on prescriptions following the label changes last year. Those changes highlighted the risk of tremors, depression, anxiousness and suicidal behavior to Singulair's label.

"We do not expect this to be a meaningful issue and are not changing our estimates," Morgan Stanley researchers said in a note.

As for patients, the FDA urged them to talk to their doctors.

"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," the FDA said.

Merck shares were off 15 cents at $44.55 in afternoon trading on the New York Stock Exchange.

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#2 jbren

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Posted 28 March 2008 - 07:12 PM

Having done A LOT of research for something else entirely, I came across some bad stuff about Singulair about 5 months or so ago. So nasty that I INSISTED my daughter take my granddaughter off of it...immediately. I don't want to go into it right now, but if you know anyone on this...especially a child...please have them stop ASAP.
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#3 dalilavender

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Posted 31 March 2008 - 11:42 PM

Yikes, good work Jbren.

Singular is reasonably poorly tested at this point for problems such a suicide and depression. I would bet that this story will continue to grow and grow.
"If you can cultivate the right attitude, your enemies are your best spiritual teachers because their presence provides you with the opportunity to enhance and develop tolerance, patience and understanding."
-His Holiness the Dalai Lama

Raincoast ETSY

"What you are now is the result of what you were. What you will be tomorrow will be the result of what you are now."
- Dhammapada

#4 jbren

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Posted 01 April 2008 - 05:20 AM

If you want to read some heartbreaking...not to mention SCARY stories, just Google 'Singulair message boards' and fasten your seatbelts.
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#5 dalilavender

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Posted 01 April 2008 - 09:24 AM

This connection between Singular and suicide challenges thoughts on suicide. Over the years I have seen many hearted debates on suicide. Many think it is soley a selfish choice derived act.

In many jurisdictions suicide is deemed illegal, rendering families unable to receive any benefits or life insurance which would normally be associated with an accidental death.

Suicide which could be attributed to the use of prescribed medications will have a broad scope of effects on many people.
"If you can cultivate the right attitude, your enemies are your best spiritual teachers because their presence provides you with the opportunity to enhance and develop tolerance, patience and understanding."
-His Holiness the Dalai Lama

Raincoast ETSY

"What you are now is the result of what you were. What you will be tomorrow will be the result of what you are now."
- Dhammapada

#6 soapaddict

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Posted 01 April 2008 - 05:41 PM

ARgh! That's terrible!!!

You know what tho... suicide is an act of 'choice' requiring a certain amount of planning.... unlike being high or drunk or other judgement impairing acts such as falling down, or tripping or slurring speech. All temporary afflictions.

If a drug can CAUSE us to do that, I think the implications there about drugs altering human behavior are frightening.

#7 jbren

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Posted 02 April 2008 - 05:29 AM

You are right to an extent, Helen. If you read some of those message boards, you will see that the act of suicide itself is not what is being talked about.

Among other things, it is the Suicide Ideation, that which is defined as a medical term for thoughts about suicide, which may range from vague or unformed urges to meticulously detailed plans and posthumous instructions.

As my original research had nothing to do with suicide, I was led to some of these discussions just as we are led to other things on a soaping forum. Do a search for one thing, and you wind up reading about 10 other things that have nothing to do with your original search.

I digress...all I can say is...after my granddaughter stopped taking Singulair...she had a growth spurt, started to gain some much needed weight and was all around a happier and healthier child.
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