MIRAPEX for RLS: Another Case of the Cure Being Worse than the Ailment?

MIRAPEX TV Commercial

I can't stand that commercial!

What strikes me about it, though, is the side-effects cited at the end.

"Mirapex may make you drowsy or cause you to fall asleep during normal activities, like driving....consult your doctor.....if you experience increased gambling, sexual, or other urges..."

So, your legs aren't flapping around anymore, but now you have narcolepsy and OCD. That's just great! More med sales for the pharma industry, coming up!

I did a quick search and came up with pages of lawsuits against the makers of MIRAPEX, originally a Parkinson's treatment, stemming from compulsive behavior allegedly caused by the drug.

MIRAPEX lawsuits

Just who are the makers of MIRAPEX? Our old buddies over at Monsanto, that's who! There is a great thread on them by member Dulcimer that I will link to below, and highly recommend, but suffice it to say they are behind saccharin, Agent Orange, asparatame, PCB's, and a laundry list of other wonderful products.

Monsanto
I suppose, from how deep these guys are in, they could probably market horse apples to cure arthritis and get away with it.

I have heard alfalfa does wonders to relieve joint pain.


[edit on 28-8-2007 by Icarus Rising]

I have to ask where you see the link between the Monsanto Company and the production of Mirapex? Mirapex is produced by Boehringer Ingelheim Pharmaceuticals, and although Monsanto has been known for mergers with Pharmaceutical companies such as Pharmacia in Sweden, and Upjohn Company in the United States. It appears that Pharmacia & Upjohn work with Boehringer Ingelheim for the promotion and marketing of certain pharmaceuticals, but that Mirapex itself is actually synthesized by Boehringer Ingelheim. This means that Monsanto is an direct marketer of the drug, but that the drug is not manufactured by them. If there a further of a correlation between the two companies in the production of this medication then I could be missing it. Even so, I fail to see why it would be a big deal as FDA regulations state that all active and inactive ingredients must be supplied in order to be approved for sale in the United States...sort of a last Quality Assurance check before being released.

Website for Mirapex: Mirapex, Boehringer Ingelheim

FDA link between Mirapex and Pharmacia & Upjohn: Link

As with any medication, Mirapex (Pramipexole) will have side effects and certain toxicity levels associated with drug interations if not taken properly. This particular medication works to restore the dopamine receptors interactions with each other in the Basal Ganglia, which is responsible for human movement and motor function. Eratic interactions between neurotransmitters and Dopamine receptors in the Basal Ganglia can directly affect body movement, as well as sustained damage to this area of the brain. Dopamine itself has several different functions in the human body, one of which includes the regulation of blood pressure by inhibiting sodium from reaching the Renal Proximal Tubules, which in turn causes muscle relaxation for people with Parkinson's Disease and RLS. The other function of Dopamine is to regulate the sense of reward the brain gets from a certain activity. In fact, it acts in much the same way that many illegal drugs do...to decrease the functionality of the receptors D1 and D3, thus making the other receptors essentially work double time to make up for the lost Dopamine output. This increases the desire and pleasure one derives from certain activities and can have a direct effect on drug use, gambling, sexual activity, etc.

Most medications, such as Mirapex, work to control and regulate very specific functions in the human body. In some cases there are adverse side effects, and this is something the person about to start the medication regimen needs to discuss with their physician. I have seen more than a few cases of patients not telling their physician what other medications or drugs they are currently taking, which completely negate the benefits and create harmful drug interactions that cause those side effects. Anyone taking medications that interact with Dopamine release are going to have many of the common problems that people taking Mirapex will.

Wow. You sound like a lobbyist for the pharmaceutical industry. Are you? Do you get paid to defend MIRAPEX?

Nice, the way you not so subtly blame the patient for not being honest with the doc.

I guess you think all the lawsuits are frivilous, too, huh?

There's nothing wrong with the drug, its the people that take it that are all screwed up.

What a concept!

I got the impression Monsanto was involved from the link in light blue I posted that spells M-o-n-s-a-n-t-o. Scroll down to where it lists medications. But then I guess you are partial to Boehringer Ingelheim Pharmaceuticals. Do they sign your paycheck?

If you are what I think you might be, you are being way too transparent for me, and probably for the rest of this board, as well.

Thank you, and good night.

RLS is one of many illnesses that are caused by chemicals in the food, water and personal care products.

You can find a lot of information about the increase in illnesses that relate directly to the increase in chemicals over the last hundred years at this website: www.hundredyearlie.com....

I used to have RLS at the same time I was having depression. I was on medication for over 6 years for depression. Then I found out that depression is caused by chemicals in the food, water and personal care products that we use. When I changed my diet to consume organic foods instead of chemical-laced foods, my depression disappeared and so did the RLS.

Pretty much every drug being pushed on TV is nothing but a scam to get people on more prescription medications. The government's intention is to make you sick, not well. Don't trust any of those drug-pushing commercials. The only way to be healthy is to eat organic food and use organic products.

You can find tons of eye-opening information at this website: www.newstarget.com...

That's what I'm talking about! Thanks for saying it straight out.

This stuff has pissed me off so bad for so long that I now resort to sarcasm and ridicule whenever I come across anybody that supports it. I know I am walking the fine line of a warning, but it is a defense mechanism for me just this side of a profanity laced tirade.

May God, and ATS forgive me.

Icarus Rising,

You posed a question about Mirapex and it's pharmacological side effects and ties to Monsanto, but when I give you a straightforward answer you resort to childish quips about who I work for. If you are not prepared to hear information that directly contradicts what you write then I suggest you find another message board to post on. If everyone on ATS agreed with each other don't you think it would be a pretty boring place to visit? On top of that, I don't know why it even matters who I work for, but to satify your need for apparent approval I will tell you that I am a Virologist that now works in HIV/AIDS prevention, and I have always had a keen interest in Pharmacology & Toxicology. If you want to have a conversation about the side effects of a certain medication or the ingredients in a medication then lets debate that, and leave the insults at the door.

I have read through your links, but a few dubious websites are not going to convince me that Monsanto's Pharmacia & Upjohns is anything more than a marketer of Mirapex, which is manufactured by Boehringer Ingelheim Pharmaceuticals. I have provided some of my own proof for this in my link to the FDA website. I get the feeling that you just don't understand the science behind the manufacturing of medications and you're making personal remarks to avoid the issue. I'm very willing to be proven wrong, but if your making claims that I don't see evidence for in your own links then what do you expect me to do?

Gee, I'm sorry I hurt your feelings. I am more than prepared to hear contradictory information. Apparently, it is you that are not.

I don't think MIRAPEX is a safe drug, there is plenty of evidence it isn't, even in the commercial marketing it, and I have a dubious view of the whole pharmaceutical industry, which you appear to support.

This is a conspiratorial themed website, and your response to my thread raised the red flags of the agendaed debunker to me. Don't try to engage my sympathies with your HIV/AIDS work, either. As far as I know, that is just a front for your real job; supporting the pharmaceutical industry in general and MIRAPEX specifically. If you are genuine, then I apologize. I still think you are stumping for big pharma though, maybe just doing the wrong thing for the right reasons. It happens, you know.

I will speak my mind on this issue, and yes, I can be abrasive. In my own defense, it has been 112* F the last couple days, with no relief in sight, and the heat is making me cranky.

If you don't like it, that's too bad. Maybe you should find another board to participate in. At the very least you should find another thread to respond to, imo.

Good day.

Friend, I only "debunk" ideas that are unsubstantiated and unfounded in their merit as true conspiracies. Whether you think Mirapex is a safe medication or not matters very little to me as I have already previously informed you of the potential risk when taking not only this medication, but any medication. Also, why would I try to gain your "sympathies" about my work? You clearly indicated you wanted to know what I do for a living and I gave you a straightforward answer...something many people here won't do.

Now, instead of trying to debate me with insults, which is an interesting tactic in itself, why don't you present me with more evidence in your defense and get back to the issue at hand? As I stated previously I am very willing to be proven wrong, but not with information from dubious websites. As a member of ATS I do find it highly insulting that another member would use frivolous insults to defend their point of view and circumvent the issue at hand. Why not get back to the issue and try to prove me wrong with "real" information?

Its been done, just not to your satisfaction. Labelling a website's credentials dubious is an opinion, not a fact. In fact, it is a favored tactic of agendaed debunkers around here. I consider mainstream news sources dubious in this day and age. Again, I suspect you consider all the lawsuits dubious, as well.

If you feel insulted, that is your problem. I am questioning your motivations, not trying to insult you.

I think we will have to agree to disagree about this issue. You may continue to act surprised, show concern, and deny, deny, deny. Another favored tactic of agendaed debunkers on this site, and anywhere those who subvert the truth practice their thing.

Peace!

[edit on 30-8-2007 by Icarus Rising]

I want to know more about the science of this drug.

IF RLS goes untreated, what happens, other than the wife messing up the covers at night?


Second, what is the potential for abuse. A lot of college fraternities have "casino night." Would this stuff be spanish fly, causing "gambling, sexual and other urges?" Or would it just make your girlfriend hang out in the church basement, waiting for the next Bingo game to break out.

Could I sue if I bought a bunch of loser lottery tickets?

Thanks for the levity.

Those are some good questions, too. I don't have the answers. I don't gamble, and my sexual urges are pretty much maxed (or is it maxxed?) out after five plus years of being celibate.

It brings a whole new meaning to Jackson Browne's "Rosie".



[edit on 30-8-2007 by Icarus Rising]

My husband suffers from RLS (as does his mother and his maternal grandfather). He describes it as electricity running through his legs. We've probably all had the experience of just dozing off at night and then your body jerks awake. That's how it starts for him and just gets worse. He has to get up and walk around, usually for hours. Every time he tries to go to sleep, he gets that tickling, aching, electricity sensation and has to move. Even taking medication every night does not always help. He still has some really bad nights. And even when he does get to sleep, he is still jerking and kicking (usually me) all night. He also has had nights where it not only affects his legs, but goes into his arms and chest too. He says it feels like a panic attack.

He has tried several different meds, including Mirapex. He has just recently started taking Requip. He, his mom, and his grandfather have all found that a med will work for a while and then stops becoming effective. Recently a doctor told me he uses Lyrica for all his RLS patients. We'll be checking into that.

Doing this night after night for years has really taken it's toll. He is constantly exhausted and the rest of his life suffers because of it. He has gained weight, has memory problems and his joints hurt all the time. Which in turn makes it hard for him to play with our kids, do anything with me, even concentrate at work.

I know RLS is real. Please don't get the impression that I am making light of RLS or those who suffer from it. My issue is with big pharma and the drugs they make causing more problems than they solve.

Perhaps you could try the organic diet that worked for the poster above? In any event, I pray that your husband, and you, get some relief from the life challenges caused by RLS.

[edit on 30-8-2007 by Icarus Rising]

Icarus, I wasn't at all offended. I just thought I'd throw out there what it is like for my husband and how it affects the whole family. I'm not big on putting meds into my body (they are, after all, poison...we just use them for their specific side effects) and don't get me started on pharma companies. But when the negative reports about Mirapex came out, my husband said he'd take the chance of having ill side effects if it meant just a few more hours of sleep a month. That's how desperate he gets.

And yes, I'll have to talk to him about going organic. Although, if you knew him, you'd laugh at the thought.

Edit to add:
I guess my point is, there are some people who are so desperate and in so much pain (from RLS or other things) that they just don't care about what side effects a med might have. When you get to that point, it just doesn't matter.

[edit on 30-8-2007 by otherhalf]

reply to post by otherhalf

But when the negative reports about Mirapex came out, my husband said he'd take the chance of having ill side effects if it meant just a few more hours of sleep a month. That's how desperate he gets.

Big pharma relies on that desperation to peddle its deadly wares. It is sickening. I even suspect they go out of their way to create circumstances that lead to such desperation.

I can relate. I have an annular tear at L5/S1, and extensive nerve damage and scar tissue in that region from surgical complications that caused a major spinal fluid leak. I often get creepy crawlies in my legs and feet, but they are nothing compared to the explosive, white light low back pain and bilateral radiculopathy, not to mention the low-pressure headaches I started out with. I haven't slept more than two or three hours at a stretch in years. I have been referred for a morphine pump, one thing I will never accept.

I put my faith in God for healing, not big pharma.

One thing I find very interesting is pain maintenance. So many people with chronic pain, and the medical community tries to deal with it by using meds to basically dull or cover the pain. For example, a morphine pump, like you said Icarus. You either have to choose continuous pain or being doped up all the time. Not much of a life either way.

I know a lot of people have found relief through acupuncture, hypnosis, and other means. Too bad these methods aren't more accepted, especially by insurance companies.

Edit to add:
Sorry, kinda getting off topic now. Didn't mean to turn this away from Mirapex.

[edit on 30-8-2007 by otherhalf]

Icarus, since you can’t stay on the topic at hand without the insults let’s try to get back to some semblance of order and talk about the science behind the medication. Here is a detailed description of the medication, its precautions, and the side effects:

Medical Science behind Mirapex

Mirapex (manufactured by Boehringer Ingelheim, and co-marketed by Pharmacia & Upjohns) contains the following Chemicals:

Active:
Pramipexole Dihydrochloride Monohydrate- only active ingredient in this product, as I have already described its effects on Dopamine levels and the Basal Ganglia there is no need to go further with a description.

Inactive:
Mannitol- a naturally occuring polyol found in nature.
Corn starch- starch from the grain of the Maize plant, or obtained from the endosperm of corn kernels.
Colloidal silicon dioxide- poorly absorbed by the human body, used as an inactive ingredient.
Povidone- sometimes known as polyvinylpyrrolidone, it’s a common antiseptic used for disinfection in hospitals.
Magnesium Stearate- known as Magnesium Salt, it’s typically obtained from cattle, and used to lubricate molecules in medicine and food (Candy contains the same thing).

These are the only chemicals in this medication, and that is not to say that this one active ingredient does not come without side effects. As I have previously noted, Pramipexole works by binding to D1 and D3 receptors and restoring the function of the Dopamine receptors in the Basal Ganglia. Because this medication interferes with the the part of the brain directly in care of the body’s movement you can clearly see it’s benefits to people with movement disorders. However, in lieu of the fact that it controls dopamine levels in the brain it’s effect on the “pleasure” center gives tremendous credence that it can play a role in gambling and sexual activity. I am not debating the fact that this medication causes these side effects, because it clearly does, as has been noted by Boehringer Ingelheim in their original clinical trials with the medication. Taking any medication is a risk that the patient assumes when they begin their regimen. It is also up to their primary care provider to discuss the implications of taking medications that can cause these types of side effects.

The only thing we seem to be debating about is who actually manufacturers the drug. I have clearly shown and proven that Monsanto and their subsidiary known as Pharmacia and Upjohns only play a role in the distribution and marketing of the medication, but that it is actually manufactured by Boehringer Ingelheim who also co-markets the drug with the aforementioned company.

Monsanto, I will totally agree with you, is not what I would consider a supremely “ethical” company in what they manufacture, and there has been quite a bit of debate about this very issue. In fact, Monsanto has been investigated by the Environmental Protection Agency on more than a few occasions for possible contamination and pollution with its solvents. They have also been under inquiry and admitted to bribing Indonesian officials to avoid environmental regulation, which as we all know is not very ethical in any sense of the word.

This being said, I don’t see where the conspiracy lies with their marketing of Mirapex, as I have listed all the ingredients found in this medication, and it offers little evidence that there is anything lethal inside the drug. The FDA and the European Commission have both approved the sale and release of Mirapex to the general public (including that the drug is manufactured by Boehringer Ingelheim), and you can read about its use for RLS, on top of Parkinson’s disease, here at the bottom of the page:

Medscape: Approval for Mirapex

Or, directly from the FDA website indicating the date of release, manufacturers name, and all documentation concerning it’s release:

FDA Approval for Mirapex

[edit on 30-8-2007 by Jazzerman]

You are making me laugh now. Thanks for that. You have an incredible capacity for ignoring the point and content of my posts and going right on with your spiel.

We aren't arguing about anything. I made a mistake when I said Monsanto makes the stuff, but I wasn't far off the mark. They are involved in getting it to market, aren't they?

The FDA is an old joke around here, and I'm sure the European Commission is no different. Money talks, and those guys are all ears, if you know what I mean.

You still haven't commented on what you think of the legitimacy of all the lawsuits I linked to.

I do admire your stick-with-it-ness. Too bad you use it to support big pharma. You are starting to remind me of the guy from the movie "Thank You For Smoking." You know who I'm talking about, right?

I thought Mannitol was a laxative. Maybe not in the levels present in MIRAPEX, though. Its probably in there to mask the awful flavor of the noxious active ingredient.

The U.S. Food and Drug Administration's regulation for mannitol requires the following label statement for foods whose reasonably foreseeable consumption may result in the daily ingestion of 20 grams of mannitol: "Excess consumption may have a laxative effect."
source

What is your stance on horse apples as a treatment for arthritis?

[edit on 30-8-2007 by Icarus Rising]

Even though I've already stated that RLS (and other illnesses) are caused by chemicals in the food supply, I have also read that placing a bar of soap under the bed sheets (around the lower leg area) will alleviate RLS symptoms. I don't know how it works but a lot of people claim that it does work.

My original RLS symptoms appeared many years ago when I had silicone breast implants. 90% of my pain disappeared about a month after I had them removed. The rest of it disappeared when I changed my diet to organic foods only. So did my depression.

The most important thing is stay away from chemicals. Don't eat processed food. Don't drink beverages or water with added chemicals. Don't use personal care products with chemicals. Chemicals are dangerous. They cause the majority of the illnesses in our society today.

Don't believe the media when they tell you that you need prescription medications. Most every illness can be cured with natural organic foods and herbs. Mother nature gave us everything we need to survive and be healthy. Chemicals are not one of them.

Go read about how our government has increased our exposure to chemicals over the last 100 years while telling us that they're good for us.
www.hundredyearlie.com...

Go lookup your personal care products and see how dangerous they really are: www.cosmeticsdatabase.com...

Do you know what happens when you mix aspertame, msg, sugar, food colorings, fragrance and ammonium laureth sulfate? No one does... but it might be RLS, cancer, alzheimers or a million other things. People mix hundreds of dangerous chemicals in their bodies everyday. Why? Because the media tricks us into thinking all of the food and products we use are safe. They are not.

Icarus, I am glad we are getting back on topic. Everyone needs to know the basics about whatever it is they are questioning, and my last post alluded to that fact. Now, to answer a few of your questions...

1. Yes, Monsanto is involved in the marketing of the product, but not the manufacture.

2. Whatever you think of the FDA is only speculation in my mind until I see some proof. I'm not saying that you can't persuade me with evidence, but I cannot believe anything without some hard facts.

3. As for the legitimacy of the lawsuit claims I have a few different stances I take on this issue. For one, I am not a lawyer, so I cannot comment on the legitimacy of the claims nor their legal implications. Having said that, Mirapex was approved for sale in the United States in 1997, and with a bit of research I was able to find that the Muhammad Ali Parkinson's Research Center did some clinical trials back in 2003 showing a link between the medication and compulsive gambling. If you want exact figures it appears they tested 529 patients and 8 of them (1.5%) had problems with compulsive gambling. You can see the results of this study here:

Compulsive Disorder risk with Mirapex

This was apparently the first trial showing that neurological symptoms were noticeable, and it was subsequently published in the Journal of Neurology. On top of this, it appears that Boehringer Ingelheim then started to give physicians notice of the adverse side-effects from taking this medication. With this evidence, I would casually state that anyone noticing these symptoms between the years 1997 and 2003 has a legitimate claim for a lawsuit, but anything post-2003 would be a claim against the physician themselves.

4. Mannitol can be used as a laxative in higher concentrations (20mg or higher as you correctly stated). However, when implemented in the manufacturing of medications and food products it is used as a sweetner because the doses are far less than the 20mg limit. When used as an inactive ingredient as it is in Mirapex the concentrations are very low, and because it cannot permeate through cellular membranes it essentially has no way to interfere with biological functioning. I have never tasted Pramipexole in its base form and nor would I want to...as you mention it probably tastes pretty awful.

5. Horse Apples? I will admit that I have never heard of them before, so I actually had to look them up, and then realized you were inquiring about Hedge Balls (here in the stix of Kansas we call them Hedge Balls...LOL). In answer to your question I have never seen any clinical research on the beneficial properties of the fruit from the Osage Orange Tree (Hedge Tree), and I would be intrigued to see evidence on this subject if you have any. Growing up on my parents farm we used to go out to the fields and pick Hedge Balls off the trees with my father and place them in the basement to help ward off coackroaches and crickets, and they did seem to work quite well. As for their use in cancer treatment I have never read a study conducted on the beneficial properties they may hold, so I do not have an opinion about this issue. I am not a huge fan of Homeopathic and Alternative medicine, as most studies have demonstrated that these forms of treatment do little for the illness. However, used as a preventative measure I could see where this type of medicine could come into play.