Singulair Adr Report, Myocardial Infarction, Nervous System Disorders, Balance Disorder, Pain 13

Posted over a year ago

Below is the latest ADR report on Singulair from the United Kingdom. I deleted side effects reports by very small numbers of patients in order to keep the post briefer. This shows the total number of reports since Singulair was approved in the UK. ... more »

I don't know the total number of prescriptions for Singulair in the UK. It is considered expensive.

Drug Analysis Print
Drug name: MONTELUKAST
Drug name: MONTELUKAST Report type: Spontaneous
Report run date: 13-May-2008 Report origin: UNITED KINGDOM
Data lock date: 09-May-2008 08:00:02 PM Route of admin: ALL
Period covered: 01-Jul-1963 to 09-May-2008 Reporter type: ALL
Earliest reaction date: 01-Jan-1997 Reaction: ALL

Cardiac disorders-TOTAL 64
Palpitations 29
Myocardial infarction 6
Tachycardia 6
Diarrhoea 84
Dyspepsia 24
Abdominal pain 98
Abdominal pain upper 22
Nausea 84
Vomiting 52
Dry mouth 15
Asthenia 13
Fatigue 45
Malaise 32
Sudden death 1
Pyrexia 10
Chest discomfort 12
Feeling abnormal 16
Influenza like illness 17
Irritability 18
Drug interaction 13
Chest pain 13
Arthralgia 59
Myalgia 38
Muscle spasms 24
Pain in extremity 14
Balance disorder 10
Lethargy 16
Somnolence 23
Psychomotor hyperactivity 25
Headache 221
Dizziness 68
Neuropathy peripheral 7
Convulsion 6
Epilepsy 7
Dysgeusia 7
Hypoaesthesia 6
Tremor 18
Nervous system disorders TOTAL 526
Abnormal behaviour 13
Agitation 12
Anxiety 18
Aggression 30
Depression 23
Insomnia 58
Abnormal dreams 12
Nightmare 49
Hallucination 21
Sleep disorder 15
Psychiatric disorders TOTAL 364
Asthma 36
Allergic granulomatous angiitis 43
Angioedema 12
Swelling face 12
Erythema 13
Pruritus 32
Rash pruritic 17
Rash 55
Urticaria 33

TOTAL NUMBER OF REACTIONS 2841
TOTAL NUMBER OF FATAL ADR REPORTS* 19
TOTAL NUMBER OF ADR REPORTS* 1489

2 Replies

Flindy - i called merck this week to report matts side effects, the rep was so nice and took all the information, she asked if they could contact our doctor, then she asked if matt had recieved any follow up blood tests???????This is now bothering me maybe i should have questioned that question more instead of saying no????

Posted over a year ago - Reply

Concernedcitizen - You are brave to report your story to Merck. Many people are so leary of drug companies these days because of how out of control their advertising and marketing policies are. The best way for me to make my point is to invent a story about a hypothetical drug to use as an example. Let's say that I was a researcher who wanted to find a way to help people with asthma knowing that about 10% of the population suffers from asthma. Then from data, I knew that fungus such as aspergillus was found in many asthma cases and that asthma was associated with the presence of hyper-reactive airways with unusually large numbers of eosinophil populations. So then, I hypothetized that eosinophils would not present themselves unless the area of infection was deprived of nitric oxide and eosinophils had to come to the rescue to provide a much, much more serious defense against invading organisms. If the airway is over-reactive due to hyper-sensitivity, then the presence of an over-abundance of eosinophils would cause significant inflammation to the airway tissue. So I started with that and tried to figure out the pathways. Okay, arginine is the source of nitric oxide production. Micro-organisms are very good at finding ways to defend themselves against their host's defence mechanisms. There are organisms that chemically disable arginine so that it cannot be used to produce nitric oxide. And, there are viruses that consume it and use it to replicate. So I knew that I cannot do anything with arginine because the asthma patient probably has some kind of a problem going that with arginine that I wouldn't want to make worse. So my idea was to invent a NITRIC OXIDE DONOR drug and deliver a source of nitric oxide right to the area of inflammation. The presence of nitric oxide would then down-regulate all of the processes that summon the eosinophils and their count would go down dramatically. So my idea worked. I located the receptors that communicated with the eosinophils. By using aspergillus as a receptor agonists, I identified that dipicolinic acid pyridine 2,6 dicarboxylic acid which is found on the spore case activated the cysLT1 receptor. By knowing what activated a receptor, I tried similar molecular structures such as quinolines to see if it would bind to the receptor but not activate it. Then I structured the molecule to use the volatile quinoline nitrogen as the source of nitric oxide. A low dose of nitric oxide goes a long way not much is needed so 10 mg. worked fine. My hypothetical drug would work fine if the patient had the same profile as the model for the drug and the patient was properly monitored. But for my hypothetical drug, the doctors would need to know absolutely everything about the profile of the model so that people who did not fit the profile wouldn't be subjected to unnecessary risks and adverse side effects. My drug would require genetic testing for best results. My hypothetical drug would not ever be selected for marketing by a pharmaceutical company because it would not be the kind of block buster that they want. My drug would probably only work for about 40% of asthma patients. My drug also should not be used for extended periods of time but only to control episodes of excess eosinophils. Pharmaceutical companies don't want to tell doctors how drugs work these days. Look at how many times, they say that they don't know exactly how it works. OF COURSE, THEY KNOW HOW IT WORKS. These companies think that we are idiots. They just don't want doctors to second guess who the drug won't work for. And, they just don't want doctors to second guess what kind of adverse side effects to expect. My hypothetical drug would never be marketed by any pharmaceutical company these days because it couldn't be turned over to a Madison Avenue advertising company to run a promotional campaign like they are selling potato chips.

Posted over a year ago - Reply

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