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Below is the latest ADR report on Singulair from the United Kingd...

Posted at 7:35 PM on Jun 18, 2008 by concernedcitizen, #31512
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. 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
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Reply 2 months ago on Jun 19, 2008 by flindy, #9288

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????

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Reply 2 months ago on Jun 19, 2008 by concernedcitizen, #9304

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.

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