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Milnacipran
- the next wonder
drug?
by Karen Kaufmann MS,
CCN, Phi Beta Kappa
Every once in a while, a new pharmaceutical
drug appears that dramatically changes the medical approach to a particular
illness. A good example of this is the antidepressant Prozac®.
Prozac was patented in
1977 and launched into the world marketplace in 1987. By the spring of 1990
Prozac had appeared on the cover of Newsweek, Time, and the New
Yorker and was proclaimed the new “wonder drug,” as well as a powerful new
weapon in the fight against depression.
Now another new drug-
Milnacipran, may have an even greater impact on the market place. It is
certainly positioned to improve the quality of life of a vast number of people.
According to the World
Health Organization, 121 million people currently suffer from depression
worldwide. An estimated 5.8% of men and 9.5% of women will experience a
depressive episode in any given year. Equally as important, 2% to 4% of the
population in industrialized nations suffer from one of a number of debilitating
chronic pain syndromes including Fibromyalgia, Chronic Fatigue Syndrome, and
Systemic Lupus Erythematosus (Lupus). These syndromes have challenged physicians
and patients alike, since they are difficult to characterize and even more
difficult to treat.
Lupus is a bit different
because it is an autoimmune disease where the body has turned on itself. The
person with Lupus can manufacture antibodies to over 116 different endogenous
proteins and fight off these proteins as if they were foreign, dangerous viruses
or bacteria.
Fibromyalgia and Chronic
Fatigue are chronic pain illnesses which are characterized by widespread
musculoskeletal aches, pains, stiffness, soft tissue tenderness, general
fatigue, and sleep disturbances. Patients with Fibromyalgia or Chronic Fatigue
experience a wide range of symptoms which may include headaches, migraines,
impaired memory and concentration, dry eyes and mouth, vision problems,
Raynaud’s phenomenon, and other neurological disturbances.
These illnesses are quite
debilitating and present many unique challenges. The patient actually looks
quite well and in most instances, the blood tests are normal. It is easy to
assume this individual is not physically ill at all. The problem must all be “in
his/her head” and a visit to the psychiatrist is in order. These syndromes have
only recently been recognized. In fact, the experts still question whether
Fibromyalgia and Chronic Fatigue are two different diseases, or just different
presentations of the same disease. With the average patient waiting about 5
years for the correct diagnosis, the diagnosis of Fibromyalgia and Chronic
Fatigue is often a diagnosis of exclusion.
The clinician must rule
out other diseases and base their diagnosis on a number of clinical criteria
defined by the American College of Rheumatology (ACR). There are still
physicians who question whether Fibromyalgia and Chronic Fatigue are true
disease entities. The patient is facing a host of baffling, invisible,
unpredictable, painful, and exhausting symptoms and when he/she finally turns to
the physician for help, answers do not come quickly. It is no wonder that
chronic pain conditions such as Fibromyalgia , Chronic Fatigue, and Lupus share
a number of clinical characteristics with depression.
Indeed, chronic pain can
lead to depression and depression can cause chronic pain. I should point out
however, that is quite possible to suffer the debilitating fatigue and
widespread pain that so often accompany these conditions and experience no
depression at all. The exciting fact is this new antidepressant Milnacipran,
appears to be extremely useful in treating the most intractable aspects of all
these syndromes and perhaps many more confusing, painful syndromes that are a
part of life in the 21st century.
Milnacipran is the first
in a new class of antidepressants that are Norepinephrine Serotonin Reuptake
Inhibitors (NSRIs). Milnacipran has an equal preference for norepinephrine
and serotonin and it is clear that both norepinephrine and serotonin are
involved in depression and chronic pain.
Since the early 1990’s the
preferred pharmacologic treatment for depression has been the SSRIs such as
Prozac and Paxil®. This is largely due to the improved tolerability of the SSRIs
over the older antidepressants such as amitriptyline (Elavil®) which are
tricyclic antidepressants (TCAs), although the SSRIs are not without side
effects- the most notable side effect being sexual dysfunction.
Now for more than a
decade, the treatment of depression has relied upon the single acting SSRIs, but
in many ways, the SSRIs fall short. This is because moderate to severe
depression is more effectively treated by the older Tricyclics because these
agents target more than serotonin. The vast body of evidence now shows that
drugs that increase serotonin alone, or norepinephrine alone, are equally
effective in treating depression. However, norepinephrine is clearly more
important in treating pain. Until recently, the most effective way to increase
both norepinephrine and serotonin was through administering a Tricyclic.
The Tricyclics affect 6
different targets, and as a consequence, they have numerous side-effects
including dry mouth, weight gain, drowsiness, fatigue, confusional states,
disorientation, cardiac abnormalities and the list goes on. When you are
suffering from a baffling, chronic illness and your major complaints are “brain
fog,” pain and debilitating fatigue, the last thing you want to do is take a
medication that can cause fatigue or confusion. Trust me, I can tell you this
from my own personal experience. That is why Milnacipran is a potential lifeline
for so many people. Unlike many drugs in its category, Milnacipran is NOT
metabolized through the cytochrome p450 system. This means the medication is not
likely to interact with other medications.
On a personal level, I can
tell you that I have been challenged by Lupus for the last 13 years. Lupus
is one of many autoimmune diseases that can cause widespread pain, extreme
fatigue, and a host of other symptoms. Unlike Fibromyalgia and Chronic Fatigue;
Lupus can be life-threatening, but it can also be quite mild, as it is in my
case. In Lupus your immune system can attack anything… any of the major
organs including the kidneys, the heart, the lungs, the blood system and the
brain. My special challenge has been the brain. I have suffered from brain
fog, cognitive dysfunction, and severe migraine syndromes. About 2 years ago I
developed an extremely difficult neuropathic pain condition called trigeminal
neuralgia, secondary to the Lupus. Trigeminal neuralgia is called the
suicide disease and were it not for the medications I have gotten from IAS, I
might have considered something that extreme. I tried all the medications
that are used to treat this disease including the anti-epileptic drugs such as
Neurontin® and Topamax®. In addition, I tried the Tricyclics. I could not
tolerate the side effects of these medications. Eventually the pain became
manageable with a regime of long acting and short acting opioids. Those drugs
were the choice of last resort.
But now, for a little over
2 weeks I have begun taking Milnacipran (brand name Ixel®). According to
the clinical trials, one should begin to see the pain reduction benefit at about
week number 8. I am happy to report I have already reduced my pain medication by
one third and I remain completely hopeful that this reduction is just the
beginning.
In addition, I seem to
have much more energy. The phase II clinical trials in the US were recently
completed and the results were amazingly positive. No one dropped out of the
trial because of side effects, which is virtually unheard of. Plus I have
spoken to numerous rheumatologists who are involved in treating people with
Fibromyalgia and Chronic Fatigue, and they just cannot wait until this
medication is available. As professionals they feel the previous therapies
they have offered their patients have met with limited success. It is
wonderful that there is now a medication that promises to improve the quality of
life of so many people.
Milnacipran may become the next wonder drug,
and in a few years time be on the front covers of those well known public
magazines I mentioned earlier, but remember you heard it here first!
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