Asacol discontinued. What now?

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LindyLoo52
New Member


Date Joined Apr 2013
Total Posts : 5
   Posted 4/27/2013 7:11 PM (GMT -6)   
I received a letter from my mail order pharmacy stating that all Asacol products would no longer be produced because they contain dibutyl phthalate, an inert ingredient the FDA found to be harmful. Asacol 400 mg has been replaced by Delzicol 400 mg. My insurance won't pay for the Delzicol and the pharmacist at the mail order pharmacy suggested Asacol HD. I was concerned because my dose of Asacol is 3-400 mg (1200 mg) 3 times per day. The HD is 800 mg so I would either take one tablet at 800 mg or 2 at 800 (1600 mg) which is more than I take to stay in remission. My GI doc has prescribed the Asacol HD but I cannot find any reference to say that the FDA will allow Asacol HD to be manufactured. I am reluctant to start this new form only to find out it will be discontinued also.

Anyone find any additional info or know if the HD form contains the dibutyl phthalate?

LindyLoo

DX in 2005 with moderate UC treated with Asacol and steroids
In remission for 3 years taking only Asacol and periodic Immodium

Guardian7
Veteran Member


Date Joined Apr 2006
Total Posts : 1930
   Posted 4/27/2013 7:14 PM (GMT -6)   
Congrats on staying in remission.

Is asking your doctor a script for lialda or apriso a possibility? I remember transitioning from asacol to lialda with no issues, but everyone is different. You just have to take those two times a day, assuming you are taking max dosage.

Both of them have savings card as well if you are tight on money.

Post Edited (StealthGuardian) : 4/27/2013 6:18:38 PM (GMT-6)


notsosicklygirl
Forum Moderator


Date Joined Dec 2008
Total Posts : 10316
   Posted 4/27/2013 8:49 PM (GMT -6)   
Lialda is 1200mg. I switched to Lialda from Asacol and I've been doing well. Maybe it would be your best option.
Co-moderator: Ulcerative Colitis
Diagnosed with Pancolitis, Laryngopharyngeal Reflux & Migraines. Battling Extreme Exhaustion.
Currently: 6mp (25mg) + Lialda (2400mg) + Canasa (1g PM)

ScienceGirl
Veteran Member


Date Joined Oct 2012
Total Posts : 511
   Posted 4/27/2013 11:23 PM (GMT -6)   
I don't think going up to 1600mg/day would really be all that bad, given how minimal Asacol side effects are. Asacol HD is NOT being discontinued (my doctor confirmed it).
26yo female
Diagnosed with moderate pancolitic UC 10/07, severe 2/13
Flares: 8/07-12/07, 7/10-1/11, 2/12-ongoing
Currently taking: Asacol HD 6x/day, 6MP 50mg/day, mesalamine enemas nightly
Remicade: 3/6/13, 3/18/13

Boston, you're my home

scum1
Veteran Member


Date Joined Aug 2012
Total Posts : 695
   Posted 4/28/2013 12:56 AM (GMT -6)   
Asacol HD is NOT being discontinued and they have a discount card you can sign up for. My Asacol HD is actually cheaper now than my regular Asacol used to be. You have to call them to set up the discount card.
In a flare right now
Currently taking
Asacol HD 3x daily
Uceris
mesalamine enema nightly(not during this flare)
Past drugs:
Cipro
Flagyl
Prednisone Tapered down finally and I'm off the pred
Asacol
Imuran(generic) failed due to liver issues with it

LindyLoo52
New Member


Date Joined Apr 2013
Total Posts : 5
   Posted 4/28/2013 6:28 AM (GMT -6)   
Thanks for the info. I will try the HD and perhaps it will even help with the occasional loose stools I have now and take ammonium for.

garylouisville
Veteran Member


Date Joined Aug 2012
Total Posts : 6545
   Posted 4/28/2013 7:18 AM (GMT -6)   
Did anyone ever figure out why Asacol is being discontinued due to a bad ingredient but for some reason Asacol HD is not? Also, it seems to be that Asacol's replacement is just Asacol put into a capsule that dissolves in the stomach but for some reason that is ok but Asacol is not?
Asacol 400mgs 2 pillsX3; VSL#3 112.5mgs 1 pillX2; Prescrip Assist Probiotic 1 pill X 2;Vitamin D3 5000 ius 1 pillX2;Bentyl;DAO;Folic acid

Discontinued: Robinul; Natural - peppermint oil, Inflaguard (Boswellia), Pepto Bismol, Omega 3 fish oil, Imodium, Beano, Lactaid;Zymactive, Renew Life Probiotic 80 billion, Florastor, DGL, Monolaurin, slippery elm;black cherry concentrate

journey2health
Veteran Member


Date Joined Oct 2009
Total Posts : 2681
   Posted 4/28/2013 8:21 AM (GMT -6)   
I have a truckload of Asacol 400s. Does that mean I should stop taking it now?
Pancolitis since 8/09. Inflammation under control through mesalamines since 6/10 - Asacol 2400 mg. daily; Rowasa enemas nightly, calcium supplements. No gluten, corn, soy, peanuts, alcohol, processed foods -- eggs, dairy and sugar, only if unavoidable and in tiny amounts. Green Smoothies, Can't kick caffeine. Bipolar/anxiety/depression: lamictal 100 mg Lexapro 7.5 mg.

quincy
Elite Member


Date Joined May 2003
Total Posts : 25732
   Posted 4/28/2013 11:21 AM (GMT -6)   
ellen...it would mean you take the asacol till it's gone but you'll be replacing it with something else...at least, that's what I'd be doing.

q
*Heather* I give suggestions, do with them what you will.
Status: ...Asacol 3 @ 2x daily; Salofalk enema @ 3rd night (nightly/ flares, tapered/maintenance)
~diagnosed January 1989 UC (proctosigmoiditis)
~Bentylol 20mg as needed; Zantac 150mg; Pulmicort/Airomir (asthma);Effexor XR 37.5 (depression)
~vitamins/minerals/supplements; Probiotics....(RenewLife Ultimate Flora Critical Care+Primadophilus Reuteri capsules @ bedtime)
~Metamucil capsules 6 twice daily with meals; Vitamin D 4500 IU
~URSO for PBC(or PSC?) 500mg X 2 daily (LFTs back to NORMAL!!)
My doc's logic.. "TREAT (FROM)BOTH ENDS" worth it !!!

AZYooper
Veteran Member


Date Joined Mar 2010
Total Posts : 1119
   Posted 4/28/2013 1:54 PM (GMT -6)   
Asacol HD also contains dibutyl phthalate.

www.rxlist.com/asacol-hd-drug.htm

I bet the replacement of asacol with a "new" drug called Delzicol is nothing but a ploy to retain patent protection. Asacol HD was created for the same reason. Asacol HD is virtually identical to asacol and receives no additional patent protection in Canada and other countries but the crazy US drug laws aren't that sensible. An additional problem is that HD wasn't FDA tested as a maintenance med. Not a health issue IMHO but insurance companies may refuse to cover it long term. Insurance is obviously refusing to cover Delzicol because they see it as a renamed drug that should be going generic.

We can all hope a generic asacol gets to market in the US but that may not happen. Canasa lost it's patent 3+ years and no generic has appeared. Depressing really.

You can read about the phthalate issue on wikipedia. Not sure whether to worry or not. I think I would stay away if I were a young woman of child bearing age. It is one of those compounds that should be banned until proven safe.

scum1
Veteran Member


Date Joined Aug 2012
Total Posts : 695
   Posted 4/28/2013 2:24 PM (GMT -6)   
AZYooper I think you are exactly correct
In a flare right now
Currently taking
Asacol HD 3x daily
Uceris
mesalamine enema nightly(not during this flare)
Past drugs:
Cipro
Flagyl
Prednisone Tapered down finally and I'm off the pred
Asacol
Imuran(generic) failed due to liver issues with it

ScienceGirl
Veteran Member


Date Joined Oct 2012
Total Posts : 511
   Posted 4/28/2013 2:30 PM (GMT -6)   
Patents run out. You don't get to restart the clock on a patent just because you discontinue the product.

I don't know why they're discontinuing Asacol (and not Asacol HD), why insurance companies aren't covering Delzicol, or why there aren't any generics popping up yet, but I don't think there's a way to keep the patent from resetting, time-wise.
26yo female
Diagnosed with moderate pancolitic UC 10/07, severe 2/13
Flares: 8/07-12/07, 7/10-1/11, 2/12-ongoing
Currently taking: Asacol HD 6x/day, 6MP 50mg/day, mesalamine enemas nightly
Remicade: 3/6/13, 3/18/13

Boston, you're my home

garylouisville
Veteran Member


Date Joined Aug 2012
Total Posts : 6545
   Posted 4/28/2013 4:23 PM (GMT -6)   
But why is dibutyl phthalate not ok with Asacol but it is ok with Asacol HD and why can they just put whole Asacol pills in a capsule to make Delzicol and that is OK? It still has dibutyl phthalate. Is this a directive from the FDA or did the pharm company make all this up themselves?
Asacol 400mgs 2 pillsX3; VSL#3 112.5mgs 1 pillX2; Prescrip Assist Probiotic 1 pill X 2;Vitamin D3 5000 ius 1 pillX2;Bentyl;DAO;Folic acid

Discontinued: Robinul; Natural - peppermint oil, Inflaguard (Boswellia), Pepto Bismol, Omega 3 fish oil, Imodium, Beano, Lactaid;Zymactive, Renew Life Probiotic 80 billion, Florastor, DGL, Monolaurin, slippery elm;black cherry concentrate

Meemers
Regular Member


Date Joined Sep 2010
Total Posts : 331
   Posted 4/28/2013 6:10 PM (GMT -6)   
It's called let's milk the patent cow as long as possible.
Oct. 2009 Mild UC.
Sept 2010 MAJOR flare, full pancolitis.
2011 left sided colitis.

Current meds.
Lialda 2 X a day
Canasa (have been able to eliminate since starting acacia)
5,000 IU's vitamin D3
calcium
Magnesium (slow mag)
Multi vitamin
Acacia fiber (NOW brand, not Heathers!)
Was taken off endocort via new GI after being on it for 1 1/2 yrs, so far not horrible.

garylouisville
Veteran Member


Date Joined Aug 2012
Total Posts : 6545
   Posted 4/28/2013 7:43 PM (GMT -6)   
But is the dibutyl phthalate a real problem or not? Seems like that would come from the FDA. If it was from the FDA I'm not understanding anything. If the pharmacy made up the whole thing about dibutyl phthalate then that makes more sense.
Asacol 400mgs 2 pillsX3; VSL#3 112.5mgs 1 pillX2; Prescrip Assist Probiotic 1 pill X 2;Vitamin D3 5000 ius 1 pillX2;Bentyl;DAO;Folic acid

Discontinued: Robinul; Natural - peppermint oil, Inflaguard (Boswellia), Pepto Bismol, Omega 3 fish oil, Imodium, Beano, Lactaid;Zymactive, Renew Life Probiotic 80 billion, Florastor, DGL, Monolaurin, slippery elm;black cherry concentrate

LindyLoo52
New Member


Date Joined Apr 2013
Total Posts : 5
   Posted 4/28/2013 9:55 PM (GMT -6)   
It is my understanding that the dibutyl phthalate is used in the coating of Asacol, omeprazole and some other time released drugs. It apparently will only dissolve at a certain pH as it makes its way down to the colon. It is this characteristic that delivers the Asacol active ingredients (the mesalamine) to the colon and not before. I suspect that the FDA has tested those who take Asacol to determine the levels in UC patients. From what I have been reading, the levels are astronomical in comparison to those not taking Asacol. Why not Asacol HD? Your guess is as good as mine but I suspect that Asacol HD will be affected by the FDA ruling as well as other time released drugs. The formula for Delzicol does not have the DBP and I do not know what is used as the coating, but I understand that this new "formula" will need to be taken 1 hour before or after meals. Don't know about any others of you, but my meds are spaced out 5 times during the day. Can't do any more!

LindyLoo52
New Member


Date Joined Apr 2013
Total Posts : 5
   Posted 4/28/2013 10:19 PM (GMT -6)   
The info I read was in "Prescription drugs can deliver high doses of phthalates," Environmental Health News, Nov 10, 2008.
"Every day for three months, the patient took a prescription drug called Asacol to treat his inflamed colon. Unbeknownst to him, every pill he swallowed also delivered a dose of a hormone-altering, industrial chemical. The man, who lived in the Boston area, was contaminated with about 100 times more dibutyl phthalate than ever recorded before in a human being. His daily dose of the chemical was double the amount that the U.S. Environmental Protection Agency considers safe . . . The Boston area man was prescribed an extraordinary dosage of Asacol – 12 pills a day, which is double the highest recommended dose on the manufacturer’s label. He took it for three months, twice as long as recommended."

What about those of us who take more each day or have taken it for years? The article goes on to give studies that suggest that there may be hormonal changes in infant boys and fertility issues in men.

What else? "Congress enacted a law in August (of 2008) banning the chemicals in toys and other children’s products. But their use in prescription drugs and over-the-counter medications is approved by the U.S. Food and Drug Administration."

This is outrageous that the FDA has allowed this chemical to continue to be used in the manufacture of drugs long after it was banned in children's toys, which are not ingested! I can't even think about it right now, I am so angry. Think I will ask my doc for alternatives and do some research on all the ingredients before I decide if the risk is worth the benefit.

meyerlemony
Regular Member


Date Joined Oct 2012
Total Posts : 136
   Posted 4/29/2013 12:31 AM (GMT -6)   
AZYooper said...
Asacol HD also contains dibutyl phthalate.

www.rxlist.com/asacol-hd-drug.htm

I bet the replacement of asacol with a "new" drug called Delzicol is nothing but a ploy to retain patent protection. Asacol HD was created for the same reason. Asacol HD is virtually identical to asacol and receives no additional patent protection in Canada and other countries but the crazy US drug laws aren't that sensible. An additional problem is that HD wasn't FDA tested as a maintenance med. Not a health issue IMHO but insurance companies may refuse to cover it long term. Insurance is obviously refusing to cover Delzicol because they see it as a renamed drug that should be going generic.

We can all hope a generic asacol gets to market in the US but that may not happen. Canasa lost it's patent 3+ years and no generic has appeared. Depressing really.

You can read about the phthalate issue on wikipedia. Not sure whether to worry or not. I think I would stay away if I were a young woman of child bearing age. It is one of those compounds that should be banned until proven safe.


You got it! I found a publication from a med conference about just that. Asacol was going to be going generic and they didn't want to compete, so they basically change it a little and change the name and get to charge the same crazy price with a new patent.

garylouisville
Veteran Member


Date Joined Aug 2012
Total Posts : 6545
   Posted 4/29/2013 7:46 AM (GMT -6)   
I thought it was discovered that Delzicol is nothing but an Asacol pill put inside of a capsule that dissolves in the stomach, thereby becoming nothing more than just an Asacol pill from that point on?
Asacol 400mgs 2 pillsX3; VSL#3 112.5mgs 1 pillX2; Prescrip Assist Probiotic 1 pill X 2;Vitamin D3 5000 ius 1 pillX2;Bentyl;DAO;Folic acid

Discontinued: Robinul; Natural - peppermint oil, Inflaguard (Boswellia), Pepto Bismol, Omega 3 fish oil, Imodium, Beano, Lactaid;Zymactive, Renew Life Probiotic 80 billion, Florastor, DGL, Monolaurin, slippery elm;black cherry concentrate

Sara14
Veteran Member


Date Joined Mar 2007
Total Posts : 3766
   Posted 4/29/2013 12:00 PM (GMT -6)   
Lots of info./input here as well: http://www.healingwell.com/community/default.aspx?f=38&m=2689473
29 years old; diagnosed pancolitis March 2007

Asacol, 6 tabs, 2xday; Rowasa nightly; Ortho Tri-Cyclen; Singulair; Allegra; Deva multivitamin; B-12. Vegan diet.

"I know you're tired, but come, this is the way." - Rumi

Daysailer
New Member


Date Joined Apr 2013
Total Posts : 2
   Posted 4/30/2013 8:07 PM (GMT -6)   
garylouisville said...
"I thought it was discovered that Delzicol is nothing but an Asacol pill put inside of a capsule that dissolves in the stomach, thereby becoming nothing more than just an Asacol pill from that point on?"

1st post
Newbie here. Male, 58, 10 years remission on Asacol. Just received surprise RX change to Delzicol. Researching it, found this forum....

After reading Gary's post above, pulled Delzicol capsule apart and found a tablet visually identical to my Asacol tabs.
Weighed it on a gem scale.
Delzicol = 0.554g Asacol = 0.553. (have used and proven accuracy of this scale for many years).
Delzicol tab length is 0.09 mm longer than the Asacol. 14.98mm vs 14.89mm.
Sides of tab (flat to flat), Asacol tab,also, very slightly smaller.

I dont have any resources or skills to verify the chemistry, but color, shape and weight are the same. Asacol tab very slightly smaller. (need an accurate caliper to see the difference tho.) Only other difference is the black "0572 DR" lettering on the Asacol tabs. Delzicol tab (inside the capsule) no lettering.

Hope this post is not out of line. (not the way I would usually choose to introduce myself, but more than a bit piqued about this)

Will we ever really get the "rest of the story" on this ?

Thanks to all who are involved in this forum. Admin and every poster THANK-YOU !

Post Edited (Daysailer) : 4/30/2013 7:14:59 PM (GMT-6)


soystud
Veteran Member


Date Joined Jan 2004
Total Posts : 4965
   Posted 4/30/2013 8:41 PM (GMT -6)   
this is one of the big reasons why i tweak my diet - i don't like being dicked around, especially by greedy ass big pharma - take your assacol, dezicol, whatever and shove it !

Post Edited (soystud) : 4/30/2013 8:02:02 PM (GMT-6)


LindyLoo52
New Member


Date Joined Apr 2013
Total Posts : 5
   Posted 4/30/2013 8:56 PM (GMT -6)   
I find it interesting that by opening the capsule, the tablet inside looks exactly the same as the Asacol. Is this some kind of "shell game?" Or is there something in the chemistry of the DBP that we don't understand. Why does covering it with a capsule (in the Delzicol) that dissolves in the stomach protect us from the covering dissolving further down the GI tract. The DBP would still be in our systems. I just don't get it!

I sent an email to the pharmacist(s) at the mail-order pharmacy asking about the difference between the two and is the DBP also in the Delzicol. I also asked if the Asacol HD would no longer be manufactured because of the FDA ruling. Let's see what comes back.

garylouisville
Veteran Member


Date Joined Aug 2012
Total Posts : 6545
   Posted 4/30/2013 9:29 PM (GMT -6)   
That's exactly what I don't get either and I also don't get why the DBP on Asacol is ruled bad by the FDA but the coating on Asacol HD is OK? Is the coating on HD different than the coating on regular Asacol?
Asacol 400mgs 2 pillsX3; VSL#3 112.5mgs 1 pillX2; Prescrip Assist Probiotic 1 pill X 2;Vitamin D3 5000 ius 1 pillX2;Bentyl;DAO;Folic acid

Discontinued: Robinul; Natural - peppermint oil, Inflaguard (Boswellia), Pepto Bismol, Omega 3 fish oil, Imodium, Beano, Lactaid;Zymactive, Renew Life Probiotic 80 billion, Florastor, DGL, Monolaurin, slippery elm;black cherry concentrate

Sara14
Veteran Member


Date Joined Mar 2007
Total Posts : 3766
   Posted 4/30/2013 10:31 PM (GMT -6)   
Keep is posted LindyLoo! I'd like to know that too.
29 years old; diagnosed pancolitis March 2007

Asacol, 6 tabs, 2xday; Rowasa nightly; Ortho Tri-Cyclen; Singulair; Allegra; Deva multivitamin; B-12. Vegan diet.

"I know you're tired, but come, this is the way." - Rumi
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