Leukotriene receptor antagonists symptoms and conditions

The studies published to date demonstrate that leukotriene receptor antagonists are sometimes more effective than placebo, are no more effective than nonsedating antihistamines, and are less effective than intranasal corticosteroids in the treatment of allergic rhinitis. The combination of a leukotriene receptor antagonist and an antihistamine has not been proven to be more effective than either agent alone. This review reveals several inconsistencies that require resolution. First, whereas leukotriene receptor antagonists are predicted on the basis of their mechanism of action to improve nasal congestion significantly, clinical studies reveal leukotriene receptor antagonists to be no better than antihistamines at improving congestion. Second, leukotriene receptor antagonists would not be expected on the basis of their putative mechanism of action or nasal challenge data to improve significantly sneezing, nasal itching, or drainage. However, some studies show improvement in these symptoms during treatment with leukotriene receptor antagonists. Considered in aggregate, the data available to date do not clearly support a unique role of leukotriene receptor antagonists in the treatment of allergic rhinitis whether or not it is accompanied by asthma.

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.

From a UK Yellow Card Report.

Montelukast

The product information for montelukast has been amended to include the following ADRs: Reaction No. of UK Yellow Card reports

Nausea 63 Diarrhoea 54 Rashes 52 Insomnia 44 Dizziness 42 Fatigue 37 Vomiting 24 Pruritus 24 Arthralgia 20 Urticaria 19 Malaise 18 Dyspepsia 13 Myalgia 12 Dry mouth 9 Anaphylaxis 4 Angioedema3

In addition, the following suspected ADRs have been reported and are still being evaluated: psychiatric disorders (63) ; also nightmares (13), sedation (13), palpitations (12), tremor (10) and increased sweating (10).
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Zafirlukast The most frequently reported ADRs under the Yellow Card Scheme for zafirlukast have been rashes (7), headache (7), abdominal pain (6), nausea (6) and pruritus (5). All of these are included in the product information which has also been updated to include the following ADRs that have been identified from data other than UK Yellow Card reports: urticaria, angioedema, blistering, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopenia and agranulocytosis (both very rare). Churg-Strauss syndrome Churg-Strauss syndrome (CSS) is a rare syndrome characterised by a history of asthma, and often rhinitis and sinusitis, with systemic vasculitis and eosinophilia. There has been a recent increase in the number of reports of CSS associated with the use of anti-asthma drugs, particularly the leukotriene receptor antagonists. The MHRA/CSM have received 63 reports of CSS through the Yellow Card Scheme since 1963, 59 since the beginning of 1998; Of these, 90% were associated with drugs used to treat asthma (mainly leukotriene receptor antagonists). In many, but not all cases there was documented evidence of a reduction or withdrawal of oral corticosteroid therapy prior to the onset of the reaction. There are clear warnings regarding the possible association with CSS in the product information for montelukast and zafirlukast. Prescribers should be aware of the possibility that, although rare, CSS may be the underlying cause of asthma in their patients. In patients prescribed a leukotriene receptor antagonist prescribers should be alert to the development of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or peripheral neuropathy. The identification of new and suspected ADRs emphasises the important role of the Yellow Card Scheme in helping to ensure the safe use of medicines. The safety profile of leukotriene receptor antagonists remains under close review. Please continue to report all suspected ADRs to montelukast (Singulairt) and zafirlukast (Accolatet) through the Yellow Card Scheme.1. MHRA/CSM Current Problems in Pharmacovigilance 1998; 24:14.
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http://64.233.169.104/search?q=cache:3fU602hhlG8J:www.mhra.gov.uk/home/groups/pl-p/documents/publication/con2023236.pdf+montelukast+ADR&hl=en&ct=clnk&cd=10&gl=us

From Canada:

Leukotriene receptor antagonists: suspected adverse reactions

The cysteinyl leukotrienes are inflammatory mediators that bind to cysteinyl leukotriene receptors found in the human airway and cause a number of airway actions including bronchoconstriction, mucous secretion, vascular permeability and eosinophil recruitment.1 Zafirlukast (Accolate®) and montelukast sodium (Singulair®), marketed in Canada since November 1997 and August 1998 respectively, are competitive cysteinyl leukotriene receptor antagonists. Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in patients 12 years of age and older.2 Montelukast is indicated for the prophylaxis and chronic treatment of asthma, the treatment of asthma in ASA-sensitive patients and the prevention of exercise-induced bronchoconstriction in pediatric patients 6-14 years of age and adults 15 years of age and older.1

As of June 1, 1999, the CADRMP has received 41 reports of suspected adverse drug reactions associated with the use of zafirlukast and 22 associated with the use of montelukast. This article will discuss a serious and rare adverse reaction associated with the use of these agents, drug-drug interactions and unexpected adverse reactions that have been reported to the CADRMP.

http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v9n4_e.html

Conditions are discussed in the article.

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.