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BLOG: March 2008

Montelukast sodium side effects

If you find names like montelucast sodium - a.k.a. Singulair, an asthma and allergy drug manufactured by Merck - slightly esoteric, it is much less of a problem than to be left guessing what is it that it can actually do to you. Of course, that is pretty much common to all drugs and - for that matter - anything you consume, food included.

What is different with drugs is that each of them - supposedly - goes through extensive, unbiased testing, to determine if there are specific risks associated with its use and, if there are, to make them known.

The reality of it is different. There is more and more evidence that pharmaceutical companies have morphed this mandatory research from its intended goal of being a reliable, truthful information for the consumer into a marketing tool. And the main problem is not exaggerating drugs' benefits - it is

diminishing or concealing their possible harmful,
even deadly adverse effects.

This month, the FDA moved to put Singulair on a safety review. This comes after reports of mood changes, suicidal behavior and suicides among Singulair users. Also, after five updates to drug's label by Merck since March 2007, adding tremor, depression, suicidal thinking and behavior, anxiousness and suicide to the list of possible side effects.

How likely it is that all these adverse effects have escaped Merck's in-house testing, totaling 40 medical trials with 11,000 participants? The company maintains that the drug is safe, that they can't find direct link between its mechanism of action and suicide, and that they added warning to its label "because a suicide is life-threatening event" and they care very much to keep the consumer fully informed.

That would be nice, for a change, wouldn't it? The problem is, how much we can trust Merck, on the heels of its Vioxx (painkiller withdrawn from the market in 2004) disgrace, that

exposed its use of deceptive marketing strategies
and disregard for users' safety?

Those included tailoring Vioxx's study results, omitting its known serious possible adverse effects from the label, and presenting the authors of favorable articles about Vioxx published in the JAMA as external, while they were actually Merck's employees. Merck opted to create $4.85 billion fund to settle the claims, refusing to ever admit that Vioxx caused heart attacks and deaths.

Should we expect them to act differently now? Of course not. If cornered by public uproar and facts brought out by unbiased investigation following it, they'll pay for their way out of this "marketing plot gone bad" too, because that is what the law allows.

As to the mechanism of Singulair's action and possible side-effects, Merck - or anyone else - simply can't rule out the possibility that it may affect brain function. The drug acts by blocking cysteinyl leukotriene receptors, present on mast cells (immune system attack-cells), eosinophil (type of white blood cells) and epithelial cells (forming protective layers around internal tissue surfaces).

These receptors are also a pyrimidinergic receptors, which means that are involved in complex inter-cellular communications. This field of medicine is still full of unknowns and, despite impressive advances due to continuous research, there is no answer yet as to whether and how

interfering with these receptors in, say, epithelium lining
of the brain and brain cavities could affect the way it works.

This is one of the reasons why the FDA anticipates up to nine months to "complete ongoing evaluation" of the effects of Singulair. Of course, nothing guarantees that definitive scientific answers will be available at that time.

Meantime, rather typical - and scary - reaction to the news is taking place. Once that Singulair's potential to cause mood and behavioral problems to the point of committing a suicide became publicly known, many informal user reports have surfaced on the Web, such as this well established site for the drug users' first-hand comments, at:


These give definite indication of the drug being able to cause serious behavioral deterioration - including suicidal thoughts - especially in children. Knowing how widespread are allergies and asthma among the young, it is a major risk and concern.

The scary part is that majority of these users - most of whom will never file a formal report -

wouldn't ever come to think that the problems their child
was going through could be drug-related,

if they haven't learned about it from the media.

Only after they learned about drug's possible side effects - but not from their doctor, nor from drug manufacturer - were they able to connect the two and, apparently quite regularly, solve the problem by discontinuing the drug.

It is all but certain that many drug users are suffering without knowing that their misery is caused by the drug, or drugs, they are taking. Unknown number of them die as a result, every single day. Yet those directly responsible for it - drug companies and government's regulatory bodies in charge of ensuring drug safety - are neither eager, nor compelled to make any meaningful moves.

And that is not likely to change, as long as it is the money that controls the drug market. And, we all know, pharmaceutical companies have tons of money. This is probably the main reason why those individuals that knowingly expose others to the risk of bodily harm - including death - by concealing or distorting information on possible serious adverse drug effects,

do not face criminal charges, as they should.

And nothing will significantly change until they do.