Leukotriene receptor antagonist symptoms and conditions

My four old son has been on singulair for about two weeks. The change from wheezing/coughing attacks at night and terrible allergies during the day has been amazing. They are almost non-existent to this point a great plus. However, a i stress however his behavior and speech has been VERY INAPPROPRIATE and quite frankly it concerns me. He now states "im a bad boy" and "i dont listen" and his mornings are very testy to say the least. Granted these sound like normal 4 yr. old sayings that he would pick up from other children on the playground but how do you explain them happening almost simultaneously with his taking singulair. I find it very hard to believe that it is a coincidence and that these are normal things for a 4 yr old to say/do when all other things have remained the same. My advice is to diligently watch your child for these warning signs and find other remedies if you have reservations. Im not promoting natural cures but i am leaning toward a diet change for the whole family and consulting my doctor for food allergen testing. I hope this helps. Be Well.

Hats off to Dr. Engler. Patients need this type of support. He is a unique individual willing to tell his own experiences.

Singulair increases risk of Suicide? Don't just poo-poo the possibility

This analysis is solely the work of the author. It has not been edited or endorsed by GLG
.
Analysis By:David Engler, MD
Physician, The Allergy Clinic

Implications: It is difficult to imagine why taking Singulair would increase the risk that someone would complete suicide. After all, what does a leukotriene receptor antagonist have to do with mental health? I don't know. But doctors, ask yourself, have you ever had a Singulair patient stop taking it because it caused headaches? I have had dozens of them stop taking it because of headaches. When they attempt to try it again, the headache comes back. But the package insert says that the risk of headache is no greater than it is in people who took placebo. Try explaining that to the patient who got the headache--it's very real to them.

Analysis: The story about Singulair and suicide may be based on some cause-effect relationship. I don't know what that is, but I will tell you story of a patient I saw last week. She is a 19 year old college student, with the usual stresses of college. I have been treating her for asthma and allergies since she was 10 years old, and she had been on Singulair for about 5 years.

She was treated in the town's ER for an intentional Tylenol overdose; she took 15 of them for a headache that wouldn't go away. The usual charcoal to the stomach, with Mucomyst to protect the liver from the Tylenol went fine. While under evaluation, the ER doc also noticed she had been "cutting" her wrists and arms. She said that it relieved stress.

They asked her about the Singulair and she said it gave her bad dreams. Astutely, they stopped it. All this happened a week or so before the recent news headlines.

Is that cause and effect? No way....but remember that MRK is the same company that still denies that Vioxx can increase the risk of heart attack. Oh yeah, Vioxx. That drug would have been great as a niche drug if given to treat pain in those already at risk of a GI bleed. But, no, MRK was encouraging dentists to give it out for toothaches, and most patients in my practice who were on it had no history of GI bleed. MRK wanted Vioxx to be a billion-dollar blockbuster; had it been marketed appropriately, it may still be on the market.

So how will I change my prescribing habits? For patients who have a psychiatric history, including those who take antidepressants, I'll mention the story of this patient to those on Singulair and start asking questions to try to determine if they are brittle or fragile from a psychiatric standpoint.

This may be much ado about nothing, but what if it's not? I've learned to stop drinking the drug company Kool Aid without a few grains of salt.

FYI: Go to

http://www.drugs.com/fda/singulair-montelukast-12368.html

Singulair (montelukast)
March 27, 2008
Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients
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 analyzes, 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.

Latest FDA MedWatch Alerts...

I am a 57 year old man, who has been suffering from asthma several years. This spring my doctor put me on Singulair as an additional medicine to my cortisone-inhalator. after one month I feel symptoms of depression an mood-changing, severe ups and downs.
AND - as an additional symptom i have partially lost my feeling in some fingertips, and now parts of my left thumb and even a feeling of "cold2, mostly in my left hand.
anyone who share that symptom?
M.

I usually have allergy headaches in the morning which would go away after taking 1 Benadryl w/ Tylenol. About a week ago my doctor started me on Singulair because she was concerned about me taking Tylenol daily. The last few days I've had terrible headaches that linger most of the day. (I've continued to take the Benadryl w/ Tylenol to try to help the headaches, but it's just not working.) Today is day 7 with the Singulair, and the headaches seem to be getting worse. Are headaches common with Singulair?

One of the most important questions we should be asking as parents is:

How does Singulair - a leukotriene receptor antagonist (blocks the receptors) affect the normal function of the mast cell?

The mast cell is the FRONT LINE DEFENSE against invading micro-organisms. When Singulair was invented, there was limited knowledge regarding the mechanisms by which the mast cell performed it's function. In my opinion, the focus was very narrow - those interested zeroed in on how the leukotriene receptor performed a role in the cause of asthma attacks and how ashma attacks could be prevented. Well, that's good preventing asthma attacks. But what happens to the mast cell if that receptor is blocked on a long term basis. I am not suggesting that blocking the receptor is bad but what if the long term effect is different than what we are are lead to believe-which is this is a safe medication with no known long term effects. What if the leukotriene receptor was just blocked short term a week or two to allow the body to clean up the mess from the last attack?

I seriously question what is going on with all of these infections. Are they related to crippling the mast cell? Parents should be allowed to question. If Merck doesn't want to answer questions regarding what happens to the mast cell (including are the numbers of mast cell decreased on Singulair), then something really BIG is missing. If by any chance (unknown at the moment) that the mast cell is significantly changed and therapy by montelukast is proper on a short but not long term basis, so freakin' what if Singulair is not a huge money maker any more.

Parents deserve every answer possible when decisions regarding their child's growth and development is on the line. I hope that we get some answers.

Of course, what was there in 2002 were new questions-not necessarily answers about the mast cell. Did anybody apply this to Singulair studies?
May 2002

From Journal of Clinical Investigation

Pattern recognition receptors on mast cells
The Toll-like receptors (TLRs) fit the definition of pattern-recognition molecules, which were originally postulated to allow the innate immune system to detect the 'molecular signatures' of various infectious agents. Although the innate immune system has no memory, it shows a degree of specificity, in part because the various TLRs recognize different sets of pathogen-associated molecules. Dermal mast cells are usually associated, not with the innate immune system, but with atopic dermatitis, but Supajatura et al. have found that these cells also express TLRs. They report here that TLR4, which binds the gram-negative product lipopolysaccharide (LPS), and TLR2, which binds peptidoglycan (PGN) from gram-positive organisms like Staphylococcus aureus, induce distinct mast cell responses. Staphylococcus is known to exacerbate allergic dermatitis, but it has generally been thought to act by inducing antibacterial IgE's, which trigger mast cell degranulation by stimulating the IgE receptor. Interestingly, the authors show that the interaction between PGN and TLR2 can provoke mast cell degranulation directly, sidestepping the need for IgE receptor engagement.

I was just asked by Dr. ???, if these European reports lead to change in product information in these countries. I did post that I thought that we should try to find that out. I don't have access to that information. But I do see that the Netherlands did require that depression be added to the product information. It doesn't say the date but Merck agreed.

Artie wanted to tell us about the blood brain barrier. Where are you Artie?

The report says:

In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptoms before they started montelukast, the short latency, and recovery after withdrawal of the drug all strengthen our hypothesis that depressive symptoms are an ADR related to the use of montelukast. According to the Marketing Authorisation Holder of montelukast, depression will be added to the product information.

Mechanism: The mechanism of montelukast-induced depressive symptoms is unknown. However, montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .

From the Netherlands 2006.

This is the html version of the file http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

Page 1
Nederlands Bijwerkingen Centrum LarebMei 2007Montelukast and depressive symptomsIntroductionMontelukast (Singulair®)is a leukotriene receptor antagonist available on the Dutchmarket since 1998. It is indicated for the treatment ofasthma as combination therapy forpatients with light to moderate forms of chronic asthma which cannot be adequately controlledby inhalation corticosteroids and short-acting ß-agonists. For asthma patients for whommontelukast is indicated as asthma treatment it can also relieve symptoms of seasonal allergicrhinitis. Montelukast is also indicated in asthma prevention, if exercise-inducedbronchoconstriction is the main factor

Reports On September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depressive reactions associated with theuse of montelukast.Patient A is a female aged 55 who used montelukast 10 mg once daily for asthma associated with COPD. Concomitant medication included ipratropiumbromideinhalation, salmeterol inhalation, fluticasone inhalation, acetylcysteine, budesonide nose spray and desloratadine. Two weeks after montelukast therapy was initiated the patient experienced nightmares, a depressive symptoms, fatigue and increased dyspnoea. When montelukast was withdrawn, the first three symptoms resolved. It is not known if the dyspnoea resolved. The reporting pneumonologist stated that the increased dyspnoea also could be a sign of progressing COPD. Patient B, reported by a pneumonologist, is a female aged 39 who used montelukast 10 mg once daily for asthma. Concomitant medication included salmeterol/fluticasone inhalation, mebeverine and psyllium seed. One week afterstarting montelukast treatment the patient experienced chest discomfort, malaise,depressive symptoms and dizziness. Montelukast was withdrawn, patient outcomeis unknown. Patient C, reported by a pharmacist, is a male aged 46 who used montelukast 10mg once daily for asthma. Concomitant medication included omeprazole,salbutamol inhalation and budesonide/formoterol inhalation. Six days after starting montelukast treatment the patient got in a depressed state. The patient continued to use montelukast for four weeks but the depression did not resolve. When montelukast was withdrawn, the patient recovered. Patient D, reported by a pharmacist, is a female aged 59 who used montelukast 10mg once daily for mild to moderate asthma. Concomitant medication included mometasone nose spray, salmeterol/fluticason inhalation, oxazepam and paroxetine. Three days after starting treatment with montelukast the patient experienced insomnia and aggravation of her depression. When montelukast was withdrawn the symptoms resolved.

Page 2
Nederlands Bijwerkingen Centrum LarebMei 2007 Other sources of information drugs are known to cause depressive symptoms. However montelukasthas not been associated with depressive symptoms earlier . A Medline searchbased on the MeSH terms montelukast, leukotriens, depressive disorder and mood disorders did not yield any relevant publication. DatabasesOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depression associated with the use ofmontelukast (ROR 2.1 95% CI 0.8 - 5.7). The same day the database of the WHO contained 3466 reports on montelukast, 43 of these concerned depression (ROR1.2 95% CI 0.9 – 1.6)MechanismThe mechanism of montelukast-induced depressive symptoms is unknown.However montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .Discussion and conclusionLareb received four reports of depressive symptoms in patients using montelukast.Possible confounding includes that asthma itself has been associated with the development of depression . Inhalated corticosteroids can also exert effects onthe central nervous system. Fluticason in combination with salmeterol which isused by patients A, B and D, is associated with hyperactivity and irritability where as budesonide, which is used by patient C also has been associated with depression . The latency of montelukast-induced depressive symptoms variesfrom 3-14 days. In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptomsbefore they started montelukast, the short latency, and recovery after withdrawal ofthe drug all strengthen our hypothesis that depressive symptoms are an ADRrelated to the use of montelukast. According to the Marketing Authorisation Holderof montelukast, depression will be added to the product information.

I am disheartened but not surprised that so many doctors are dismissing these reports of symptoms that patients have had after taking Singulair. The only reports that I have found to share with you are from Europe and Canada. All of these reports pre-date the recent news stories regarding Singulair and suicide.

In addition to those reports, the most important thing that I have posted is the reference to the fact that Merck itself recognizes that there are genetics differences among patients that are directly linked to the potential efficacy of Singulair (montelukast). I posted a British reports on that subject and a reference to Merck's clinical trial where they studied genetical differences and montelukast.

The best thing that we can do is to try to convince our doctors that this is not politics -- the major does not have to rule. Why do European countries publish frequent reports on all adverse drugs reactions not just those of the majority of the people? One size does not fit all.

The actual incident of headache in all users according to European reports is 18-19%. So when I read that headache, adverse drug reaction to a leukotriene receptor antagonist (Singulair) is then treated by ibuprofen (a Cox-2 inhibitor), which of course gets treated for stomach inflammation or GERD by Nexium or another drug-histamine receptor antagonist, then I wonder what the hell is left to inhibit? So if a patient does not fit the profile of the 80%, do we have to make that patient catatonic (meant figuratively)? I realize that this leaves out all of the receptors that aren't affected by any of these drugs but I am just trying to make a point.

So why does Merck list headache as just one of the side effects in a category of side effects just listed as greater than 1%? And why do so many people believe that there is no scientific proof of any of the complaints that we see here at this site?

From the Netherlands 2006.

This is the html version of the file http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

Page 1
Nederlands Bijwerkingen Centrum LarebMei 2007Montelukast and depressive symptomsIntroductionMontelukast (Singulair®)is a leukotriene receptor antagonist available on the Dutchmarket since 1998. It is indicated for the treatment ofasthma as combination therapy forpatients with light to moderate forms of chronic asthma which cannot be adequately controlledby inhalation corticosteroids and short-acting ß-agonists. For asthma patients for whommontelukast is indicated as asthma treatment it can also relieve symptoms of seasonal allergicrhinitis. Montelukast is also indicated in asthma prevention, if exercise-inducedbronchoconstriction is the main factor

.ReportsOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depressive reactions associated with theuse of montelukast.Patient A is a female aged 55 who used montelukast 10 mg once daily for asthmaassociated with COPD. Concomitant medication included ipratropiumbromideinhalation, salmeterol inhalation, fluticasone inhalation, acetylcysteine, budesonide nose spray and desloratadine. Two weeks after montelukast therapy was initiated the patient experienced nightmares, a depressive symptoms, fatigue and increaseddyspnoea. When montelukast was withdrawn, the first three symptoms resolved. Itis not known if the dyspnoea resolved. The reporting pneumonologist stated thatthe increased dyspnoea also could be a sign of progressing COPD.Patient B, reported by a pneumonologist, is a female aged 39 who used montelukast 10 mg once daily for asthma. Concomitant medication included salmeterol/fluticasone inhalation, mebeverine and psyllium seed. One week afterstarting montelukast treatment the patient experienced chest discomfort, malaise,depressive symptoms and dizziness. Montelukast was withdrawn, patient outcomeis unknown.Patient C, reported by a pharmacist, is a male aged 46 who used montelukast 10mg once daily for asthma. Concomitant medication included omeprazole,salbutamol inhalation and budesonide/formoterol inhalation. Six days after startingmontelukast treatment the patient got in a depressed state. The patient continued to use montelukast for four weeks but the depression did not resolve. Whenmontelukast was withdrawn, the patient recovered.Patient D, reported by a pharmacist, is a female aged 59 who used montelukast 10mg once daily for mild to moderate asthma. Concomitant medication included mometasone nose spray, salmeterol/fluticason inhalation, oxazepam and paroxetine. Three days after starting treatment with montelukast the patientexperienced insomnia and aggravation of her depression. When montelukast waswithdrawn the symptoms resolved.
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Page 2
Nederlands Bijwerkingen Centrum LarebMei 2007Other sources of informationLiteratureSeveral drugs are known to cause depressive symptoms. However montelukasthas not been associated with depressive symptoms earlier . A Medline searchbased on the MeSH terms montelukast, leukotriens, depressive disorder and mooddisorders did not yield any relevant publication.DatabasesOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depression associated with the use ofmontelukast (ROR 2.1 95% CI 0.8 - 5.7). The same day the database of the WHOcontained 3466 reports on montelukast, 43 of these concerned depression (ROR1.2 95% CI 0.9 – 1.6)MechanismThe mechanism of montelukast-induced depressive symptoms is unknown.However montelukast has earlier been associated with adverse drug reactionssuch as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .Discussion and conclusionLareb received four reports of depressive symptoms in patients using montelukast.Possible confounding includes that asthma itself has been associated with the development of depression . Inhalated corticosteroids can also exert effects onthe central nervous system. Fluticason in combination with salmeterol which isused by patients A, B and D, is associated with hyperactivity and irritability where as budesonide, which is used by patient C also has been associated with depression . The latency of montelukast-induced depressive symptoms variesfrom 3-14 days. In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptomsbefore they started montelukast, the short latency, and recovery after withdrawal ofthe drug all strengthen our hypothesis that depressive symptoms are an ADRrelated to the use of montelukast. According to the Marketing Authorisation Holderof montelukast, depression will be added to the product information.References1. Dutch SPC Singulair®. (version date 11-7-2005) http://www.cbg-meb.nl/IB-teksten/23164.pdf.2. M.N.G Dukes and J.K Aronson, editors. Meyler's Side Effects of Drugs. 14 ed. Elsevier; 2000.3. Price D. Tolerability of montelukast. Drugs 2000;59 Suppl 1:35-42.4. Goldney RD, Ruffin R, Fisher LJ, Wilson DH. Asthma symptoms associated with depression and lower qualityof life: a population survey. Med J Aust. 2003;178(9):437-41.5. Dutch SPC Seretide®. (version date 12-8-2005) http://www.cbg-meb.nl/IB-teksten/23529-23530-23531.pdf.6. Dutch SPC Pulmicort®. (version date 20-10-2003) http://www.cbg-meb.nl.
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Nederlands Bijwerkingen Centrum LarebMei 2007

I posted before regarding a study that suggested that montelukast should be studied for possible psychiatric adverse drug reactions in children. I could only find the abstract. I have now located the entire article. I originally thought the study was British but it was done in Sweden. I am going to make an e-mail file. If you would like the full text of this article to take to your doctor, I will send it to you.

Individual case safety reports in children in commonly used drug groups – signal detection

Gertrud Brunlöf , Carina Tukukino and Susanna M Wallerstedt
Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, SE-413 45 Göteborg, Sweden

BMC Clinical Pharmacology 2008, 8:1doi:10.1186/1472-6904-8-

Here is the discussion and conclusion.

Discussion
ICSRs were present in 19 of the 30 most commonly used drug groups in children. The number of ICSRs varied between the groups of drugs, the two most reported drug groups being the leukotriene receptor antagonists and centrally acting sympathomimetics. The reporting of new drugs should be expected to be larger compared with old drugs, according to the Swedish instructions concerning ADR reporting. The leukotriene receptor antagonist montelukast was registered in 1998. Consequently, no extra attention to ADRs during montelukast treatment was demanded in 2005. Centrally acting sympathomimetics, on the other hand, were introduced later and the number of ICSRs may be influenced by the increased focus on this drug group. Another explanation for increased reporting rates for certain drug groups may be media attention.

ADRs during treatment with montelukast seem to occur predominantly in small children, the majority in the present study being <15 years old, whereas children according to European Medicines Agency include 0 to 17 years.
In the present study, five percent of the ICSRs in children included serious ADRs. The corresponding figure for adults was 32%. With vaccine reports included, the proportion of serious ADRs has been reported to be 13% in children .

The design of the present study does not to allow conclusions concerning the question whether the number of ICSRs per million DDD differs between children and adults. Lower doses are often used in children, making direct comparisons difficult. Moreover, dose adjustments for children compared with DDD may vary depending on age of the child as well as the drug in question, making comparisons using DDD as denominator inconclusive. The number of ICSRs in the present study is quite small, implying that minor fluctuations in the number of reports can significantly affect the result. Hence, the disposition of ADRs in children needs further investigation.

Conclusion
In conclusion, the present study indicates that ADRs are reported for commonly used drugs in children. The number of ICSRs varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

Artie commented below. I am posting Artie's comment back in a place where every one will see because I know the importance of arming yourself with research. I have worked for a major pharmaceutical company in my lifetime. I know that we need research and we need proof. Without that, we will be ignored.

Reply 1 minute ago on Apr 02, 2008 by artie81, #6536
Do you honestly think the people on this forum know how to interpret scholarly journal artcles?

Posted at 6:44 PM on Apr 02, 2008 by concernedcitizen, #29028
A British study suggests that Singulair should be studied for possible psychiatric adverse drugs reactions in children. I don't have this access to this journal so I have to try to find it. I will get back to you on what it says specifically. BMC Clin Pharmacol. 2008 Mar 17;8(1):1 Links Individual case safety reports in children in commonly used drug groups - signal detection.Brunlof G, Tukukino C, Wallerstedt SM. ABSTRACT: BACKGROUND: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children. METHODS: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<5 years old and experiencing psychiatric adverse drug reactions. CONCLUSION: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored. PMID: 18366638 The key sentence is: A POSSIBLE SIGNAL FOR MONTELUKAST (SINGULAIR) AND PSYCHIATRIC ADVERSE DRUG REACTIONS WAS FOUND, WHICH SHOULD BE FURTHER EXPLORED.

A British study suggests that Singulair should be studied for possible psychiatric adverse drugs reactions in children. I don't have this access to this journal so I have to try to find it. I will get back to you on what it says specifically.

BMC Clin Pharmacol. 2008 Mar 17;8(1):1 Links
Individual case safety reports in children in commonly used drug groups - signal detection.Brunlof G, Tukukino C, Wallerstedt SM.
ABSTRACT: BACKGROUND: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children. METHODS: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<5 years old and experiencing psychiatric adverse drug reactions. CONCLUSION: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

PMID: 18366638

The key sentence is:

A POSSIBLE SIGNAL FOR MONTELUKAST (SINGULAIR) AND PSYCHIATRIC ADVERSE DRUG REACTIONS WAS FOUND, WHICH SHOULD BE FURTHER EXPLORED.

I am Cody Millers mom ,the boy who died from Suicide while on Singulair for 17 days, I just wanted to say one thing to all of you that take the time to post.GO ONE STEP FURTHER CONTACT THE FDA and report to medwatch .The investigation needs evidence like your stories to help make informed decisions about this drug.The poorly orchestrated disclosing campaign that Merck had supposedly set out to accomplish in 2007, has obviously not reached the mass majority of people using this drug .Seeing now how many people did not make the connection to these HIDDEN AND DANGEROUS SIDE EFFECTS.Our child's pharmacy sheet that came with the medicine ,showed none of the updated side effects.They were added in April 2007,I filled the prescription in July 2007.Nothing had been disclosed until we put forth this effort to get the FDA's attention ,by asking the Senate and Congress to look into this matter.Go to your doctor and insist that they report YOUR SIDE EFFECTS to the company and the FDA.It is of the utmost importance.,Kate and Dave M.

New FDA Warning:

FDA informed health care professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidally (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 suicidally (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 analyzes, 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

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