I didnt know there was a law suit...What are you referring to?????

google daliresp lawsuit

I made a comment about this medicine in May.Dr. wanted me to take it gave me samples ..after reading side effects and the cost of this medicine,I knew it was bad news....They should be sued and so should the Drs. who give this medicine and other meds that have deadly side effects to unsuspecting patients for their own gain...Grrrr

how odd, usually when there's a class action law suit against medications, there are commercials upon commercials! this is the first I'm hearing of this as well...I've taken this for a year now & haven't had any problems except nausea, which I tend to get often from almost anything, my stomach is so sensitive! thanks for the info!

This is the only lawsuit I have heard about and it was dismissed.

http://www.clinicalleader.com/doc/physician-s-integrity-group-sues-fda-over-roflumilast-0001

I was put on a trial of Daliresp a couple years ago by my PCP (no pulmonologist at that point) and didn't last too long before I was seriously contemplating overdosing my dogs and then myself. I think that was when I was started on Paxil/paroxetine, although I may have started on it slightly before that. I stopped the Daliresp and things settled back into place. A few months later, my psyche tanks again and my Paxil is increased. Again this is where it pays to be an educated patient-consumer (well, not a consumer of patients, but you know!). While my doc didn't dwell on the mental health problems, I read up on the drug when starting it. Who knows? Maybe my whole breakdown was a psychosomatic response to what I'd read. But being aware of the potential, when I found myself collapsed on the floor with my Ativan wondering how many it would take for the shitzhu and my soul mutt to travel together down the River Styx, I knew it was time to stop the Daliresp.

Fast forward a couple years, and I have a pulmonologist. She wants me to go on Daliresp. I explained to her the problem I had with it before but she would like me to give it a try because of frequent exacerbations in the hopes of maximizing my treatment. After about four months now, there have been no problems at all.

I don't know if the ability to tolerate it this time is because I am in a generally better head space or if I was either on none or too low of a dose of Paxil originally or maybe they even slipped a little sumpin'sumpin' into the formulation (JOKE!), but in any case it's all good now, even if I don't necessarily feel like it's making much of a difference. That's the problem with our meds- it's not like taking something for pain and having the pain disappear. With us, it's a subjective thing...nothing every goes away completely and it's like those dang eye tests where "is it better with A or B?," "Is this better or worse?"

My brother was on this med and was dx w/Liver Cancer several years ago. At that time, his new doctors mentioned that there were some possible "issues" w/this med and liver problems. We are not blaming this med for his liver condition but, have since then noticed a warning on the Daliresp literature. My brother was fortunate that his cancer was "isolated to only his liver". After numerous treatments on his tumors, he finally received a transplant.

There are still many on-going medical problems; however, the "gifted" liver is still functioning.

BTW/ He also had an early stage COPD at the time. Using other COPD meds for the past 6-8 yrs. Now we notice his SOB, but no need for O2 yet.

One of the Holy Grails of current research is to find a way to specifically target inflammation/irritation (leading to increased mucus) with something other than corticosteroids. Corticosteroids have a long list of undesirable side-effects; long-range, and affect the whole body. Daliresp is one of the very few non-steroids that have shown any promise. Unfortunately it comes with a whole new set of side-effects- depression, suicide, GI track, and pancreas.

It has a higher risk to benefit ratio than many medications during clinical studies. Which is a part of the complaints against Daliresp; in addition, it is also presents a higher risk when the total prescribed population is viewed. The latter is because Daliresp has shown itself effective only within a very narrow-range: Those in the latter stages of COPD with lung inflammation causing extra coughing and mucus that cannot otherwise be controlled. However, having gained the reputation of a last resort tool without increasing corticosteroid use it is too often prescribed to people outside that narrow-range thus statistically more risk with no benefit. This is what forms the major complaint against Daliresp.

I use Daliresp and it seems to help. If anyone else uses it, I suggest they read the pamphlet that comes with it very carefully and discuss the medication with their doctor.

I'm confused & it's a boring/gloomy/rainy day here so i tried to find out more about the "lawsuit" that buickoreo was referring to.

the way i read Charley61 link & this one that I found http://www.courthousenews.com/2014/02/04/65076.htm
Are the "physicians" re filing another suit against daliresp? or is the same one still going on?

from the way I'm understanding it;
1. "FDA Advisory Committee denied approval April 7, 2010 = "daliresp wasn't effective or safe for maintenance treatment of COPD"
2. FDA approved it in Feb. 2011 "without any further clinical studies"
3. Nov. 2012 FDA rejected 'Physicians for Integrity in Medical Research (PFMIR)" petition with the FDA requesting revocation of the 2011 approval.

what I can't figure out is that 2012 PFMIR still being discussed in these 2014 news links
OR
has PFMIR filed new stuff trying to revoke daliresp in 2014???

Also, one thing I think gets lost in all of this is that I thought Daliresp only helps people with "bronchitis" type of COPD not emphysema???
however, when I look for that little factor everything uses the term COPD, so it is presented like it helps emphysema....
It is also not supposed to help bronchospasms, it is just supposed to help inflammation to help "prevent" as many exacerbations. (as gnott pointed out)

here is the info page on it;
http://www.daliresphcp.com/
the 1st paragraph states;
"INDICATIONS AND USAGE
DALIRESP (roflumilast) is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD...
associated with chronic bronchitis...
and a history of exacerbations. DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm."

My PCP wanted me to take it back in 2012 & when I read that it was only "proven" for bronchitis & had so many side effects I declined to use it.
As Gnott pointed out, for the people that "fit" into it's "narrow range" of helping, it is probably a godsend.

gosh I hope the weather clears up soon :)

Buickoreo= did you happen to bring this subject up because you take the medicine & are researching it?

itried using it a number of times,the all the side affects were so bad i stopped using it,i now have been using musinix whit good results

buichoreo= I use mucinex also, or guaifenesin.
It seems to help loosen my flem & I only take "when needed".
Much cheaper too :)

yep they have mucas relief at the dollar tree for $1.00 a bottle,same ingredients as musinex