Montelukast sodium side
If you find names like
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
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
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(painkiller withdrawn from the market in 2004) disgrace, that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
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
The scary part is that majority of these users - most
of whom will never file a formal report -
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
do not face
criminal charges, as they should.
And nothing will significantly change until they do.
┆ NUTRITION ┆