Tena, my post was in support of Mirapex, not a shot at you or anyone else in particular.

I'm confused about your response though. Were you and your friend part of the drug study group for Mirapex or was it for the Amgen drug study? Whichever it may have been, I'm so sorry that your friend took her life. It's hard to imagine being in despair so deep and black that death seems the better alternative, but obviously it happens. I hope you and others who cared about her have found peace following her passing.

As for the Amgen trials, I only know what I read on the PD forums. It was a a stunning development, IMHO, for patients to take their own interests to court - to want to continue with something that was helping them even though they knew others were experiencing dangerous side effects. That's how I feel about Mirapex. I know others may have real problems caused by the drug, but for me it's really been a great help.

I'm in a drug study now, KW-6002, which also has helped me tremendously. By being part of the study, I'm one of the people who determines what side effects - if any - this new drug can cause. All I can say is that, for me, it is another miracle drug. Selfishly, it's been great that the study has continued since I get the drug for free. But, from a more compassionate standpoint, I hope it gets FDA approval soon so it will be available to all with PD. It's that good!

Again, Tena, my sympathy to you for the loss of your friend.

No - we just happened to be the very first time it was out on the market,
brand new drug - all great adverts,
in 2000 I and many others were the first group other than clinical trial group to receive this drug, and there was no warning about anything ...
no gambling - no insanity, no hallucinations no suicide, no sudden sleep attacks, etc...
nothing...no literature... zero info...

sad enough -
that was not the last pill - I took without checking
I read your reply to therese -you take parcopa too? you have not been told it has a sugar in it that is actually a neurotoxin, [aspartame] and the pharmacy doesn't even have a warning on your bottle do they?
- just incase you are a PKU patient do they?
we'll my pharmacy knows but they did not until I told them...
also:

clinical studies usually paid for by the Pharma selling the product...
so it's a great new drug - until it goes published by other doctors etc,
that it has many side effects or complications, not so great for all,
what kills some, may not kill all, but if one died you loved -that would be too many...
now if you look Mirapex up you will see complications and warnings -
but the only thing I was told is that it could drop our blood pressures...
and that happened -so they offered me a pill to raise my blood pressure,
and I could see where that was headed because I was a pharmacy technician...to another pill until I had so many pills -similiar to the
packets I filled for the seniors - for whom I felt so badly...

in 2000 no information - you have it now because of PD patients have horrid side effects or suicide
- like all those who are now sueing for many deaths caused by many drugs... that the FDA ok'd,


there is no drug that doesn't have a side effect... none.
GDNF was a protein that keeps the brain healthy actually long ago it received a *Nobel* by a woman scientist and one man -
I knew a few the study PD people and the scientist and some of the doctors at the University of Kentucky...were the people unbelievable lost...
mistrial should have been declared -
there was no evidence of the death of monkey's or tumors or whatever the heck Amgen wanted to say ( it was a paid for done deal)
and sadder still actually no dead rhesus monkey's to be found at the University of Kentucky...
no sireee...

http://bendbulletin.injury.findlaw.c...apex-news.html

Mirapex News
November 10, 2006: FDA Approves Mirapex for Restless Legs Syndrome
Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS is a condition that causes unpleasant sensations, discomfort, and restlessness in the legs. Click here to read the press release from Boehringer Ingelheim.

August 23, 2006: Texas Woman Alleges that Mirapex Made Her a Compulsive Gambler
A lawsuit has been brought in Texas state court by a bank director from Texas, who alleges that Mirapex caused her to become a compulsive gambler, resulting in the loss of $200,000 in less than a year. The plaintiff sued Mirapex-manufacturer Pfizer Pharmaceuticals and distributor Boehringer Ingelheim Pharmaceuticals, Inc., for failing to warn doctors and patients of the risk of compulsive behavior by Mirapex users. A claim was also filed against the plaintiff's physician for failing to monitor her behavior while taking Mirapex.

June 2006: Mirapex Use Possibly Linked to Compulsive Behavior
There have been recent reports of Parkinson's disease and Restless Leg Syndrome (RLS) patients experiencing strange, out-of-control, compulsive urges while being treated with Mirapex or other "dopamine agonist" medicines. Among the strange behaviors that have been reported are cases of pathological gambling, hypersexuality (increased sexual thoughts, feelings, or behavior), and compulsive eating. Mirapex's prescribing information has been changed to describe these reported cases. Mirapex's prescribing information states that the incidence of compulsive behavior has been low, and that the behavior is generally reversible upon dose reduction or treatment discontinuation. The suggested link between Mirapex use and compulsive behavior is still under examination.

here is just a brief by the way -not really a warning to the restless leg syndrome people?

FDA approves MIRAPEX for the treatment of moderate-to-severe primary Restless Legs Syndrome
RIDGEFIELD, CT, November 10, 2006 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex® (pramipexole dihydrochloride) tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).1 RLS is a common, yet often undiagnosed,2 neurological sensorimotor disorder.3 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.4 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.2 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.1 MIRAPEX is also approved to treat the signs and symptoms of idiopathic Parkinson’s disease,1 and is supported by nearly a decade of real-world experience in the treatment of Parkinson’s disease.6

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.1 In controlled clinical trials, patients were treated with MIRAPEX for periods of three weeks up to nine months.1 In clinical studies, patients taking MIRAPEX experienced statistically and clinically significant improvements in short- and long-term efficacy versus placebo.1 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.7 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.1

Highlights from the clinical trials program in support of the approval include:

In a 12-week study, patients treated with Mirapex® (pramipexole dihydrochloride) tablets reached superiority compared to placebo on both The Clinical Global Impression – Improvement (CGI-I) and the IRLS Scale.1
Total IRLS scores at week 12 demonstrated a statistically significant improvement with MIRAPEX (13.6 point improvement) versus placebo (9.4 point improvement).1 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.1
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).1
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.1
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.8
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.1
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.1
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.1
About Restless Legs Syndrome (RLS)
RLS is a common, yet often undiagnosed,2 neurological sensorimotor disorder.3 Up to 10 percent of U.S. adults are affected by RLS.5 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.2,9 Additionally, people with RLS will often have difficulty falling asleep.10 Approximately one-third of sufferers experience symptoms more than twice weekly causing moderate-to-severe distress.11

As a direct result of RLS, patients may experience daytime tiredness, mood disturbance, and an inability to perform daily activities.4

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)2 :

Do you have an urge to move your legs, usually accompanied by uncomfortable leg sensations?2
Do your symptoms begin or worsen during rest or inactivity, such as lying down or sitting?2
Are your RLS symptoms partially or totally relieved by movement, such as walking or stretching?2
Are your RLS symptoms worse in the evening or at night, or do they only occur in the evening and at night?2
About Mirapex® (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.1 MIRAPEX is supported by nearly a decade of real-world experience in the treatment of Parkinson’s disease,6 and approximately 9.1 million prescriptions for MIRAPEX have been written in the U.S. since its launch in 1997. 12,6

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. if you notice -absolutely no data for PD clinicals that it may cause compulsive behavior?
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.

Contacts
Mark Vincent
Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
Ridgefield, CT 06877
Phone: (203) 798-4412
Email: mvincent@rdg.boehringer-ingelheim.com



Chesha Oliver
Ketchum Public Relations
Phone: (646) 935-4036
Email:Chesha.Oliver@ketchum.com




--------------------------------------------------------------------------------

References
Mirapex® prescribing information (Rev. 11/7/2006)
Allen RP, Picchietti D, Hening WA, et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med 2003;4:101-119.
Abetz L, Allen R, Follet A, et al. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther 2004;26:925-935.
National Heart, Lung and Blood Institute Working Group on Restless Legs Syndrome. Restless legs syndrome: detection and management in primary care. Am Fam Physician 2000;62:108-114.
Hening W, Walters AS, Allen RP, et al. Impact, diagnosis, and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004;5:237-246.
Mirapex (PD) FDA Approval Letter (7/1/1997)
Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.
Corbin, Ann E.; Sethi, Kapil D.; Kushida, Clete A et al. Pramipexole treatment rapidly improves patient ratings of Restless Legs Syndrome symptoms. Submitted abstract. Associated Professional Sleep Societies Annual Meeting, June 2006.
Comella CL. Restless legs syndrome: treatment with dopaminergic agents. Neurology 2002;58(suppl 1):S87-S92.
Avecillas JF, Golish JA, Giannini C, Yataco JC. Restless legs syndrome: keys to recognition and treatment. Cleve Clin J Med 2005;72:769-787.
Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, Ferini-Stambi L et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005;165:1286 -1292
IMS Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.

This is all very interesting. I have been diagnosed with Parkinson and am on Mirapex. I take 3m. a day and I have dosed off numerous times while driving. I have sleep apnea and had gained some weight and my neurologist seemed to think that was the reason and increased my cpap setting. It has helped, but I still have daytime sleepiness. It really helped my RLS initially, but now it seems to be wearing off. I knew about the compulsive behavior, etc, but I did not know it could cause excessive daytime sleepiness. I see my neurologist next week and I intend to talk to her about this.

I was on Mirapex and did develop some compulsive behaviors (spending, eating) and the doc cut the dose in half and raised the Sinemet. I'm doing reasonably well controling the behavior but at the price of more Sinemet sooner.

We all want new treatments brought to market more quickly - and, yes, left there as a choice available to us, even if some cautious pharmaceutical companies can project potential law suits! If we have our way thus, we are bound to get some drugs that have serious side effects in some of us! Is that an acceptible price to pay for getting potentially efficacious drugs out more quickly? Or should we wait unitl we are reasonably sure they are safe - as in a double-blind control group study of thousands of patients followed until they die a natural death, just to make sure that the new med doesn't shorten the life span?

It's a complicated issue.

Mirapex ruins lives. I'm not saying this drug should be taken off the market or that drugs should take a life-time to be put on the market. There is evidence though that the manufacturers were well aware of the compulsive behaviour aspect of this drug from the clinical trials, but failed to warn us.

A 2 cent sticker on the bottle could have saved me a small fortune. Why they chose to keep this side-effect hush-hush is beyond me.

dear sasha,
we are the blind placebo group, we do not know what is in the pills or if they will work for us or against...
thank you for your op/ed...
peace,
tena

hello dear bluedahlia,
I appreciate your testimony -most people will not say they had a problem with the meds, I know of several but they seem not to want to admit
the drugs made them obsessive compulsive/ I believe in a way they may have known -look at pavlovs theory/fact... used in all casino's
the bell reward system... bells ring -payoff - it is all a greed based system
the stock market rings bells -I have seen people so addicted to the stock market, the cell phone beeps everytime they are having a certain stock raise
or fall - mostly I heard these on cells from men in suits in Washington DC,
I was an advocate and nothing else -I went coast to coast,
as I was going through a divorce, caused by the insanity of the bells...
I certainly do feel deep sorrow for those whom the bells have toll,
I knew Paige sweetheart -but it lead many to a downward spiral, and I remember the drug did not immediately do this, it was over the course of
years that is slowly dulled my brain -fogged my caution lights, and I was
all by myself in very dangerous places, like DC, but for some reason
I was fearless... so I believe it was what my psychiatrict explained to me as
I was on too much dopamine - like too much cocaine -
the superman drug... and then the fallout... the fix and the fallout
the high-mania and the low depression, the brain fog actually was brutal
because to this day, I do not recall all memories of the time, just certain
memories...
so perhaps I should be more selective and give a medicinal forecast,
we see a 100% chance of taking mirapex today
for those that might be able totolerate the heat,
you may see extended periods of sunny to partly sunny daze,
with a chance of brainfog coming in...in the extended forecast watch out for tornado's and hail events and the warning bells.