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I am a clinical pharmacist currently doing freelance writing on various pharmacy topics. I graduated from Arnold and Marie Schwartz School of Pharmacy in 1988 with a bachelors degree in pharmacy. While practicing as a clinical pharmacist I obtained my Doctor of Pharmacy degree (PharmD) from the University of Florida in 2003.

Wednesday, July 13, 2011

Daliresp® Risks May Outweigh Benefits

Daliresp® Risks May Outweigh Benefits
Daliresp (roflumilast) is new oral tablet for  patients with severe chronic bronchitis. Daliresp (roflumilast) is the first in a new class of drugs called oral phosphodiesterase 4 inhibitors. It works by reducing lung inflammation. It's added to the usual bronchodilator (medications that open up the air passages in the lungs) therapy to decrease exacerbations, but only for severe, chronic bronchitis. That's because the modest benefit may not outweigh its risks. Daliresp® is linked to insomnia, weight loss, depression, and possibly suicide. There's also concern about a possible increased cancer risk, but this hasn't been proven. Patients should try maximizing bronchodilator use before trying Daliresp®. Patients should be warned to report any serious mood or behavioral changes while taking Daliresp®.

Source: Pharmacist's Letter

16 comments:

  1. raelindsay@aol.comAugust 2, 2011 at 9:10 PM

    you wrote:
    Daliresp (roflumilast) is new oral tablet for patients with severe chronic bronchitis. Daliresp (roflumilast) is the first in a new class of drugs called oral phosphodiesterase 4 inhibitors.
    rae's note: and you noted the risks involved.

    i have COPD and am sensitive to many of the meds usually prescribed for COPD, or chronic bronchitis, or emphysema, including advair, singulair, albuterol, ipratropium, etc.. instead, i rely on many vitamins and supplements, and as a rescue inhaler, use primatene mist - which does not cause me bronchospasms, and does not land me in the ER, as the other meds do.

    i've been waiting for daliresp to become available but i have had my own reservations about it, all of which you've mentioned. in the meantime, for more than a year. .i've been taking quercetin, which is currently under study for COPD. quercetin is also an enzyme inhibitor; if this works the same way as daliresp (roflumilast) i would be better off taking quercetin because i have no sensitivity or reaction to taking this natural enzyme, and seems to have fewer risks associated with it.

    i would really appreciate your opinion on this. and also - if they work the same way, how much quercetin would i have to take to equal 250mg of daliresp (another problem - the prescribed dosage of daliresp is 500 - only because they decided on that arbitrarily - not for scientific reasons, as the company's own press release admits.

    thanks so much for your attention.

    rae lindsay

    ReplyDelete
  2. Hi Rae,
    Quercetin does not work the same way as Daliresp. Quercetin's anti-inflammatory effects are in part due to the inhibition of the enzyme lipoxygenase, similar to the drug Zyflo. Lipoxygenase inhibitors decrease the production of leukotrienes, which are involved in the inflammatory process. Since Daliresp is a new drug, I am always a little hesitant to recommend them unless there are no other choices. Once a drug is used by the general population, some adverse effects arise that were not seen in clinical trials due to the small number of people in clinical trials. There is no equivalency information that I found comparing quercetin with Daliresp. I know that the most common dose of quercetin I found for COPD was 500mg taken three times a day. If quercetin has been working for you, I would stick with it since it has been around a long time and given the troubles you've had tolerating COPD medications. Make you let your doctor know exactly what you are doing. I hope I have answered your question sufficiently.
    Brian Brutman, PharmD

    P.S My blog site is pharmacymadesimple.blogspot.com

    ReplyDelete
  3. raelindsay@aol.comAugust 3, 2011 at 3:58 PM

    you wrote:

    Quercetin does not work the same way as Daliresp. Quercetin's anti-inflammatory effects are in part due to the inhibition of the enzyme lipoxygenase, similar to the drug Zyflo. Lipoxygenase inhibitors decrease the production of leukotrienes, which are involved in the inflammatory process.

    daliresp is also a Lipoxygenase inhibitor - but it doesn't work the same way?????

    Since Daliresp is a new drug, I am always a little hesitant to recommend them unless there are no other choices. Once a drug is used by the general population, some adverse effects arise that were not seen in clinical trials due to the small number of people in clinical trials. There is no equivalency information that I found comparing quercetin with Daliresp.

    roflumilast - also known as daxas in europe and other coun tries has been available for years, but i'm sure there aren't any chemical comparisons. i was seeking to find a comparison in the chemicals, not necessarily the items themselves (but i don't even know what i'm talking about here - i'm an old, and i mean old , english major).

    I know that the most common dose of quercetin I found for COPD was 500mg taken three times a day. If quercetin has been working for you, I would stick with it since it has been around a long time and given the troubles you've had tolerating COPD medications.

    i am currently taking 2400 mgs - suggested by NOW and a couple of other mftrs. and this works under "normal" situations. i'm trying to find out how much to take when i have an EXACERBATION - this happens about once a month.

    Make you let your doctor know exactly what you are doing. I hope I have answered your question sufficiently.

    brian - i know you have to say "let your doctor know" but my PCP and the pulmonologist know nothing about quercetin or any other supplements - nor do they care to know. sad but true.

    i'm going to keep taking the quercetin, but i need to know the max possible when i have one of my monthly horrors. thanks again for your interest, brian. best, rae

    ReplyDelete
  4. raelindsay@aol.comAugust 3, 2011 at 4:23 PM

    HELLO, brian: you mentioned "zyclo". i had never heard of that and just looked it up. zyclo has terrible side effects. fortunately, quercetin does not - unless of course you over do the RED WINE!!! i take my quercetin in capsule form - no harm, no foul). but that's why i'm so scared of taking DALIRESP - i'm so vulnerable to the side effects of all these meds - and so are many of us. best, rae

    ReplyDelete
  5. I could not find an optimal dose of quercetin that is used for a COPD exacerbation. All I can say is that there have been reports of kidney damage at doses around 1 gram a day. Also, if you currently have kidney problems, quercetin is probably not a good choice, since it can worsen kidney damage.

    ReplyDelete
  6. raelindsay@aol.comAugust 6, 2011 at 8:53 PM

    HI, BRIAN: U of Mich. researcher has been in touch - starting clinical trials soon. i asked him to tell me what dosage they are using. i don't have kidney damage, but i'm getting a little wary of the high doses. to be continued. best, rae

    ReplyDelete
  7. From my knowledge, the best drug to use for an acute exacerbation of COPD is Medrol.Oral steroids have been shown to calm the inflammation down quickly, and to prevent the attack from getting worse. Steroids are very potent drugs, and I don't know of any other drugs that work as well in an exacerbation of COPD

    ReplyDelete
  8. raelindsay@aol.comAugust 14, 2011 at 6:50 PM

    hi, brian: yes - i do take medrol pack - just about every month. but i'm asking all the questions about quercetin and daliresp because i'm hoping to extend my cycle - to have fewer exacerbations. i know medrol is strong - i'm vulnerable to infections, etc....and as noted i can't use any of the usual meds to prevent/treat COPD. rae

    ReplyDelete
  9. Hi Rae.
    From what I know I would stick with the Medrol each month. I have not been able to find a safe dose of quercetin to use for exacerbations, and Daliresp is still a very new product with some significant side effects. If I can find anymore information, I'll let you know.
    Sincerely,
    Brian Brutman, PharmD

    ReplyDelete
  10. I am on 500 Mg of this new med. I am having awful headaches, terrible stomach pains, severe nausea, and major tooth sensitivity. Anyone else having theses symptoms?

    ReplyDelete
    Replies
    1. I just started taking daliresp, 500 mcg..I have been feeling anxious , irritable and stressed out since taking it for about 1 week..

      Delete
    2. If you have started feeling these symptoms 1 week after starting Daliresp, you should consult your healthcare practitioner as soon as you can. There is a chance it could be due to the Daliresp, and these symptoms need to be taken care of as soon as possible in any case. Thank you for your readership.

      Delete
  11. Was put on Daliresp and after 12 days could no longer tolerate the awful side effects. Severe daily headache, stomach pain, nausea, deep leg pain/cramps from mid buttock down to feet so bad I could not sleep or hardly walk the treadmill.

    ReplyDelete
  12. Thank you for the input on Daliresp®. It is apparently a difficult medication to tolerate.

    ReplyDelete
  13. I was prescribed Daliresp by the Dr. this morning and they didn't have any at the store today but will tomorrow, anyway, I was told the only side effect was diarrhea. Now I see that some are having stomach problems. I have a problem with stomach erosion and GERD, narrowing of the esophagus. I need to know if this medicine will cause worse problems. I do have COPD stage 3. can you let me know. Thanks pandabear1046@hotmail.com

    ReplyDelete
  14. Daliresp can have more side effects than just diarrhea. The following is a comprehensive list of the side effects from pre-marketing studies.

    Common side effects of Daliresp Oral:
    Backache
    Weight Loss
    Diarrhea

    Infrequent side effects of Daliresp Oral:
    Inflammation of the Nose
    Sinus Irritation and Congestion
    The Flu
    Burning Stomach
    Indigestion
    Urinary Tract Infection
    Muscle Spasm
    Dizzy
    Chronic Trouble Sleeping
    Involuntary Quivering
    Loss of Appetite
    Head Pain
    Feel Like Throwing Up
    Throwing Up
    Stomach Cramps
    Anxious

    Rare side effects of Daliresp Oral:
    Suicidal
    Having Thoughts of Suicide

    As you can see many of the side effects can be related to the gastrointestinal system. I can not say for sure whether Daliresp will worsen your ulcer, GERD, or esophageal narrowing. I can only say that these are not contraindications for taking Daliresp. I would suggest careful monitoring of these conditions by your healthcare practitioner while you are taking Daliresp.

    ReplyDelete

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