[lou_lou]

I really do not understand why you would give this drug to anyone else
after all the PD lawsuits that resulted from this drug?
from falling asleep at the wheel to gambling and sexual addiction to suicide?
NOW -
Mirapex is given to the restless leg syndrome people who sometimes are teenagers!
and now they are prescribing it for bipolar depression?

why cant they just take it off the market?

also look at all the clinical trials with mirapex?
http://clinicaltrials.gov/ct2/result...ne+Agonists%22



FDA Approves MIRAPEX For The Treatment Of Moderate-to-Severe Primary Restless Legs Syndrome
11 Nov 2006

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex(R) (pramipexole dihydrochloride) tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS is a common, yet often undiagnosed, neurological sensorimotor disorder. While symptoms can vary from person to person, they are typically described as an urge to move the legs accompanied by burning, creeping, crawling, aching, tingling, or tugging sensations in the legs. Symptoms begin or worsen during periods of rest or inactivity -- for example, when lying down or sitting in a movie -- and generally are worse at night. Up to ten percent of the U.S. adult population is affected by RLS.

"RLS patients may experience daytime tiredness, mood disturbance, and an impaired ability to perform daily activities," said Professor John W. Winkelman, MD, PhD, Medical Director of the Sleep Health Center of Brigham and Women's Hospital, Boston, Massachusetts. "Oftentimes sufferers don't realize that they have an underlying treatable medical condition that is causing these symptoms as well as sleep disturbance. With MIRAPEX, physicians now have another option to help manage their patients' RLS symptoms."

For the treatment of RLS, MIRAPEX is approved in varying doses and should be taken once daily 2-3 hours before bedtime. MIRAPEX is also approved to treat the signs and symptoms of idiopathic Parkinson's disease, and is supported by nearly a decade of real-world experience in the treatment of Parkinson's disease.

Clinical Trials
The FDA approval was based on safety and efficacy data from four randomized, double-blind, placebo-controlled clinical trials involving approximately 1,000 patients with primary moderate-to-severe RLS who were administered MIRAPEX (0.125mg, 0.25mg, 0.5mg and 0.75mg) or placebo once daily, 2-3 hours before going to bed. In controlled clinical trials, patients were treated with MIRAPEX for periods of three weeks up to nine months. In clinical studies, patients taking MIRAPEX experienced statistically and clinically significant improvements in short- and long-term efficacy versus placebo. In three clinical studies, the mean change from baseline in total International RLS Rating (IRLS) scores for patients treated with MIRAPEX demonstrated a statistically significant greater improvement compared with placebo-treated patients. In a fourth study, efficacy was sustained with MIRAPEX over a period of nine months, including a six-month open label treatment period followed by a 12-week placebo-controlled withdrawal period.

Highlights from the clinical trials program in support of the approval include:
-- In a 12-week study, patients treated with Mirapex(R) (pramipexole dihydrochloride) tablets reached superiority compared to placebo on both The Clinical Global Impression - Improvement (CGI-I) and the IRLS Scale.

- Total IRLS scores at week 12 demonstrated a statistically significant improvement with MIRAPEX (13.6 point improvement) versus placebo (9.4 point improvement). The IRLS Scale is designed to assess the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood associated with RLS.

- The CGI-I rating scale measurements showed statistically significant RLS symptom improvement in patients taking MIRAPEX (72 percent) versus patients taking placebo (51 percent) after 12 weeks of treatment. The CGI-I is designed to assess clinical progress (global improvement).

- Efficacy was demonstrated at even the lowest doses, as 75 percent of patients on 0.25mg of MIRAPEX responded to therapy as measured by the CGI-I.

- In the same 12-week study, the Patient Global Impressions (PGI) scale was also used to rate symptom improvement, and patients reported significantly improved PGI ratings relative to placebo.

-- A second study demonstrated the sustained efficacy of MIRAPEX for the treatment of RLS in a nine-month study consisting of a six-month open label treatment period followed by a 12-week placebo-controlled withdrawal period.

- Long-term improvements were demonstrated with MIRAPEX, as at the end of the 12-week withdrawal period, 79 percent of patients who showed improvements on MIRAPEX after six months of treatment had maintained response through nine months versus 15 percent of patients treated with placebo.

- The administration of placebo to patients who had previously responded to MIRAPEX therapy in the six-month open-label treatment period, led to a rapid decline in the patients' overall conditions and return of their RLS symptoms.

About Restless Legs Syndrome (RLS)

RLS is a common, yet often undiagnosed, neurological sensorimotor disorder. Up to 10 percent of U.S. adults are affected by RLS. Patients with RLS often experience an urge to move their legs at night due to uncomfortable leg sensations that worsen during periods of rest or inactivity, often interfere with the ability to sleep, and are partially or totally relieved with movement, such as walking or stretching. Additionally, people with RLS will often have difficulty falling asleep. Approximately one-third of sufferers experience symptoms more than twice weekly causing moderate-to- severe distress.

As a direct result of RLS, patients may experience daytime tiredness, mood disturbance, and an inability to perform daily activities.

Despite many years of research and increased disease recognition, RLS still remains underdiagnosed or misdiagnosed to this day. RLS may be diagnosed with positive answers to the following criteria, which were developed by participants in the RLS Diagnosis & Epidemiology workshop at the National Institutes of Health in collaboration with members of the International Restless Legs Syndrome Study Group (IRLSSG):

-- Do you have an urge to move your legs, usually accompanied by uncomfortable leg sensations?

-- Do your symptoms begin or worsen during rest or inactivity, such as lying down or sitting?

-- Are your RLS symptoms partially or totally relieved by movement, such as walking or stretching?

-- Are your RLS symptoms worse in the evening or at night, or do they only occur in the evening and at night?

About Mirapex(R) (pramipexole dihydrochloride) tablets

In addition to now being approved for RLS, MIRAPEX, a compound from Boehringer Ingelheim research, is also approved for the treatment of the signs and symptoms of idiopathic Parkinson's disease. MIRAPEX is supported by nearly a decade of real-world experience in the treatment of Parkinson's disease, and approximately 9.1 million prescriptions for MIRAPEX have been written in the U.S. since its launch in 1997.

MIRAPEX may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving.

When taking MIRAPEX hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. The most common side effects in clinical trials for RLS were nausea (15% vs. 5% with placebo), headache (16% vs. 15% with placebo), fatigue (9% vs. 7% with placebo) and somnolence (6% vs. 3% with placebo). The most commonly reported adverse events in early and late Parkinson's disease in clinical trials were dizziness, involuntary movement, hallucinations, headache, difficulty falling asleep, sleepiness, and nausea.

Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including MIRAPEX, to treat Parkinson's disease and RLS.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and approximately 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of US $11.8 billion (9.5 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Boehringer Ingelheim Pharmaceuticals, Inc.
http://us.boehringer-ingelheim.com
--------------------------------------------------------------------------------

Article URL: http://www.medicalnewstoday.com/articles/56434.php

Main News Category: Neurology / Neuroscience

Also Appears In: Clinical Trials / Drug Trials,


http://www.medicalnewstoday.com/newsletters.php for details.

Send your press releases to pressrelease@medicalnewstoday.com


___________________


For more information: http://www.pharmacia.com/prescriptio...nt/Mirapex.pdf.

[lou_lou]

Learn More about New Medicine for Depression
There have been three controlled clinical trials and a review article that provide growing evidence for the safety and efficacy of Mirapex for treatment of bipolar depression and treatment-resistant depressions.

Mirapex has a large effect size of 0.6-1.1. This means it is a lot more helpful than placebo in bipolar depression and treatment- resistant depression. However, it has not been approved by the FDA for these conditions. It is approved for Parkinson's disease and restless legs syndrome.
Mirapex is well tolerated by most patients, although some patients report side effects such as nausea, tiredness, sedation, headache, or insomnia. Less frequent side effects are abnormal muscle movements, restlessness, sleep attacks, faintness when standing.

Rare, more serious adverse reactions include hallucinations, hypersexuality, excess spending, or compulsive eating. So far, mania, hypomania, and psychosis have occurred at lower frequencies for Mirapex than for traditional antidepressants.

You can read an abstract of the review article at: http://www.ncbi.nlm.nih.gov/sites/entrez

Type this article title into the search window:
Pramipexole in Psychiatry: a Systematic Review of the Literature.

[lou_lou]

Pramipexole in psychiatry: a systematic review of the literature.Aiken CB.
Department of Psychiatry, Wake Forest University School of Medicine, Winston-Salem, NC, USA.christopher.aiken.med.99@aya.yale.

OBJECTIVE: To assess the risks and benefits of pramipexole in psychiatric populations. DATA SOURCES: A PubMed search was performed using the keywords pramipexole and ropinirole, which identified 500 articles. STUDY SELECTION: All clinical studies in psychiatric populations were included in the primary review (24 articles). Studies involving other populations were then reviewed to evaluate potential risks and benefits not identified in the psychiatric studies. DATA EXTRACTION: Effect sizes were calculated from controlled studies. Rates of intolerable side effects and manic switching were estimated by pooled analysis of controlled and uncontrolled studies. DATA SYNTHESIS: Pramipexole has a large effect size (0.6-1.1) in the treatment of both bipolar and unipolar depression with a low short-term rate of manic switching in bipolar patients (1% mania, 5% hypomania). The pooled discontinuation rate for all reasons was 9%. Pramipexole is neuroprotective and exerts beneficial effects on sleep architecture. Pramipexole is associated with 3 rare but serious side effects: sleep attacks, which have only occurred in Parkinson's disease; compulsive behaviors and pathologic gambling, which have occurred in Parkinson's disease and restless legs syndrome; and psychosis, which has occurred in both psychiatric and neurologic populations. CONCLUSIONS: Pramipexole is an important therapeutic option for treatment-resistant bipolar and unipolar depression; further studies are warranted to evaluate its safety in psychiatric patients.

PMID: 17854248 [PubMed - indexed for MEDLINE]

read this!
mirapex for restless leg people -
http://www.mirapex.com/ -

It begins as a strange feeling in your legs that seems to get worse until you stand up and move around. Deep inside your legs you can feel burning, creeping, and crawling sensations that are hard to describe, even to your doctor. Meanwhile, you cope with your condition the best you can.

If these symptoms describe the way you are feeling, you may have restless legs syndrome (RLS), a sensorimotor condition that affects millions of Americans.

Restless legs syndrome can be a primary or a secondary condition. Primary restless legs syndrome is the main form of the disease. While no one is sure what causes primary restless legs syndrome, nearly half of the time it can be traced to a family history. There is currently no cure for primary restless legs syndrome. Secondary restless legs syndrome is caused by an unrelated condition such as pregnancy, anemia, or iron deficiency. Once the unrelated condition has been treated, secondary RLS will usually go away without further treatment.*

Living with RLS is difficult both physically and mentally and can have a major impact on normal, everyday life. MIRAPEX is a US Food and Drug Administration-approved prescription medication for the treatment of moderate to severe primary restless legs syndrome.

There are many benefits to MIRAPEX treatment:

Proven effective in the treatment of moderate to severe primary restless legs syndrome
Studies have shown sustained relief from RLS symptoms up to 9 months
If you think you are suffering from restless legs syndrome, you should consult your doctor and see if MIRAPEX is right for you.

This Web site contains information about restless legs syndrome and MIRAPEX treatment, as well as personal insights from people living with RLS.

* MIRAPEX is not indicated for secondary Restless Legs Syndrome.


IMPORTANT SAFETY INFORMATION ABOUT MIRAPEX: MIRAPEX may cause you to fall asleep without any warning, even while doing normal daily activities such as driving. When taking MIRAPEX hallucinations may occur and sometimes you may feel dizzy, sweaty or nauseated upon standing up. The most common side effects in clinical trials for RLS were nausea, headache, and tiredness. You should talk with your doctor if you experience these problems.

Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson's disease and RLS.

please do not forget the real life stories?????

heres one example
Pamela R. — age 51

I have been having creepy crawly feelings in my legs since I was a teenager. When I was younger, my mother would take me to see the doctor about my legs. He would always tell her those weird feelings I had in my legs were just growing pains. When I was younger, I didn’t think about my legs a lot because I would have episodes only a few times a year. For example, sometimes I would feel the sensation of water rushing through my legs when I sat and watched a movie. I would always miss the end of the movie because getting up and taking a walk was the only way to get rid of those funny feelings in my legs.

Over time, my symptoms became worse, and eventually I was diagnosed with moderate restless legs syndrome. As I learned about my condition, I tried various ways to help ease my symptoms. I tried hot and cold baths, exercising, massages, acupuncture, and even sleeping pills. While some things worked for a little while, nothing seemed to have any lasting effect. Soon enough I was pacing around the room at all hours of the night again. I went back to my doctor, and he prescribed MIRAPEX. For the last 6 months, my symptoms have been much better. I just have to take 1 pill every day a few hours before I go to bed, and my legs don’t bother me as much when I go to sleep.

[lou_lou]

Some people with vitamin B12 deficiency will experience symptoms in their nervous system first,

such as:


altered or reduced sense of touch


less sensitivity to vibration (inability to feel the vibrations of a tuning fork)


colour blindness


tingling in the hands and feet


muscle weakness


difficulties with walking and coordination


psychological symptoms such as memory loss, confusion and depression.

perhaps B-12 would heal the problem

instead of mirapex a drug -used forever no promise of anything but relief of symptoms perhaps - worse symptoms to come?

[vlhperry]

Dear Ctinalouise,

Please don't judge a drug by how it works for you or others. I have been taking Mirapex for 8 years now. For me it is a lifesaver. I cannot ride in a car for more than 5 minutes before I am screaming to get out. The creepy, crawley feelings in the legs is very intense. I had gone 3 to 4 days without sleep because of RLS before I was put on Mirapex. To warn people about the possibile side effects of Mirapex is helpful. To use satire to discuss the possible side effects of the drug will scare off persons from trying it who may, like me tolerate it with no side effects, is irresponsible.

Everyone is different, chemically and genetically, and can tolerate or not tolerate different drugs. Doctors need to be able to prescribe Mirapex or Requip as an option to help their patients and be able to try others if they don't work. For some it can be their only course for relief.

Peace to You,
Vicky

[chasmo]

approximately 35% of Mirapex takers have behavioral problems. Most of those have problems because they are over-medicated. 3.0 MG SHOULD be the maximum dosage IMHO.

As Vicki noted, Mirapex works for many. I do think that the company should have some cupability. Anyone who thinks they didn't know of these side-effects, well I have some beach front property in Arizona for sale!

A simple warning and followup by your MDS should stop most if not all of these bad outcomes.

Charlie

[lou_lou]

dear vickie,
I am not judging anyone that is your view of my warning

I am telling people to BE AWARE!
HUGE difference -glad it works for you -
but it does not work for ALL -and that's just a plain ole fact!
tena

Originally Posted by vlhperry

Dear Ctinalouise,

Please don't judge a drug by how it works for you or others. I have been taking Mirapex for 8 years now. For me it is a lifesaver. I cannot ride in a car for more than 5 minutes before I am screaming to get out. The creepy, crawley feelings in the legs is very intense. I had gone 3 to 4 days without sleep because of RLS before I was put on Mirapex. To warn people about the possibile side effects of Mirapex is helpful. To use satire to discuss the possible side effects of the drug will scare off persons from trying it who may, like me tolerate it with no side effects, is irresponsible.

Everyone is different, chemically and genetically, and can tolerate or not tolerate different drugs. Doctors need to be able to prescribe Mirapex or Requip as an option to help their patients and be able to try others if they don't work. For some it can be their only course for relief.

Peace to You,
Vicky

[dotty]

Originally Posted by CTenaLouise

dear vickie,
I am not judging anyone that is your view of my warning

I am telling people to BE AWARE!
HUGE difference -glad it works for you -
but it does not work for ALL -and that's just a plain ole fact!
tena

hi
i'm on sinemet and mirapexin they also work well for me. maybe i'm abit addidted to forums but that might have happened without meds.I have heard some people whos whole life has been ruined by taking these meds.I think it is very important to know side effects,but also that they do work well for some people

[DJM1]

I am another PWP who has taken Mirapex ever since it first became available and, for me, it has been a miracle drug. I think it should be prescribed by doctors who tell their patients all the potential side-effects - as with any drug they prescribe. If patients are aware of the drugs's potential to cause addictive behaviors (gambling, sexual) in SOME users, they can stop the medication should unwanted behaviors begin.

But, to stop the production and use of Mirapex all together is unfair to people like me who have benefitted greatly from it. Remember how horrible we all thought it was when Amgen stopped the patient trials of whatever drug it was because SOME patients devloped major problems with it (heart disease or cancer - I can't remember which)? PWP's in the Amgen trials SUED the company to try to force them to continue the trials for those participants who were doing so well on the drug. They lost their lawsuit and the improvement in the quality of their lives that the Amgen product had provided.

If they took every drug off the market that causes bad side-effects for users, Eldepryl (aka Selegiline) would have to be off the market based on my reaction to it. I never even managed to titrate up to a full dosage because it made me feel mean as it took effect. I was nauseaus, had hot flashes, crushing headaches, etc.etc. For me, it was an awful, awful drug but for many PWP's, it helps a lot.

So, as with any drug, make sure those who are prescribed Mirapex should be made aware of all potential risks, but don't stop producing a drug that sop many of us use with great success.

[lou_lou]

Dear DJM1 et al,
you realize the difference of stealing a good product back -ergo to continue
peoples medical /medicine addictions -Amgen I have no problem saying -
outright lied and stole and have killed many lives, because of greed...

you all may have been aware of the problems but the first group of lab rat's for MIRAPEX -
aka patients put me and others w/PD in the line of FIRE! and I was shot!
I lived but my life was hell, my girlfriend w/ PD had put herself in debt so badly, instead of coming to the first DC meeting -where Micheal J. Fox
and many devoted Parkinson's advocates showed up, ie: PaulaWitt (you know from the outstanding Grassroots PD organization and sometimes we hear from Peggy,they were there ---- but my friend back in 2000 did not show, instead I was notified by Joan samuelson's people -that Paige had taken her own life, and yes she was on MIRAPEX
so in retrospect that is the big difference, between advocates

GDNF and PD clinical trial -
and big freakin greedypharma - ie: amgen president...who at the time lied through his teeth...

it is for this reason you have MIRAPEX
-yet no cure? is because of the money... you can't make much money on healthy people / the greedy people think this because they charge the big bucks for medicine...

All I have searched for is a cure -or how to regain what was made degenerative -the body is truly amazing once you can gain a balance of health -pH balance in particular.
which is what I believed to be the goal here...and to continue w/ meds until we do not need them anymore, but as for now -we are all perhaps addicted to dopamine, or benzodiazepines
or anti-depressants...
I am trying to live and have hope, but drugs do not cure... the body if it can figure how to undue and detoxify, can show how spectacularly it is made.
sincerely,
tena


PS: I will not reply again -in my defense... thankyou

Originally Posted by DJM1

I am another PWP who has taken Mirapex ever since it first became available and, for me, it has been a miracle drug. I think it should be prescribed by doctors who tell their patients all the potential side-effects - as with any drug they prescribe. If patients are aware of the drugs's potential to cause addictive behaviors (gambling, sexual) in SOME users, they can stop the medication should unwanted behaviors begin.

But, to stop the production and use of Mirapex all together is unfair to people like me who have benefitted greatly from it. Remember how horrible we all thought it was when Amgen stopped the patient trials of whatever drug it was because SOME patients devloped major problems with it (heart disease or cancer - I can't remember which)? PWP's in the Amgen trials SUED the company to try to force them to continue the trials for those participants who were doing so well on the drug. They lost their lawsuit and the improvement in the quality of their lives that the Amgen product had provided.

If they took every drug off the market that causes bad side-effects for users, Eldepryl (aka Selegiline) would have to be off the market based on my reaction to it. I never even managed to titrate up to a full dosage because it made me feel mean as it took effect. I was nauseaus, had hot flashes, crushing headaches, etc.etc. For me, it was an awful, awful drug but for many PWP's, it helps a lot.

So, as with any drug, make sure those who are prescribed Mirapex should be made aware of all potential risks, but don't stop producing a drug that sop many of us use with great success.