Asacol is being discontinued!

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RobertS975
New Member


Date Joined Apr 2013
Total Posts : 1
   Posted 4/4/2013 4:54 PM (GMT -6)   
Asacol 400mg tablets have been discontinued. The new Delzicol 400mg is indeed a capsule. But if you open the capsule, you find a tablet that looks amazingly like Asacol! There are new restrictions on when to take the new Delzicol- one hour before or two hours after a meal.
 
If it is the same... then why do you need a new prescription. If it is the same as Asacol, then why the new restrictions with regard to meals.
Sounds like a great time to try a switch to once a day products like Lialda.
If and when generic mesalamine comes out, one can evaluate that possibility. 

scum1
Veteran Member


Date Joined Aug 2012
Total Posts : 565
   Posted 4/4/2013 6:52 PM (GMT -6)   
At least asacol HD has a discount card which actually makes it cheaper for me. Surely the generic will be out soon also
In a flare right now
Currently taking
Lialda
Cipro
Flagyl
mesalamine enema nightly
Past drugs:
Prednisone Tapered down finally and I'm off the pred
Asacol
Imuran(generic) failed due to liver issues with it

Sara14
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Date Joined Mar 2007
Total Posts : 3766
   Posted 4/4/2013 9:03 PM (GMT -6)   
Thanks for the info. Robert. That is strange. Are you taking it?
29 years old; diagnosed pancolitis March 2007

Started first course of pred 2-19-13 (40 mg), currently on 10 mg. Asacol, 6 tabs, 2xday; Rowasa nightly; Canasa in a.m. as needed for flares; Ortho Tri-Cyclen; Singulair; Allegra; Deva multivitamin; B-12. Vegan diet.

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

fadoozle
Regular Member


Date Joined Apr 2011
Total Posts : 73
   Posted 4/5/2013 1:40 PM (GMT -6)   
The letter I received today from Express scripts says the following:

"This letter is to inform you that the drug manufacturer Warner Chilcott, LLC will discontinue further distribution of Asacol (mesalamine) 400 mg and replace it with Delzicol (mesalamine) 400 mg in early to mid-April 2013.

This action is being taken because the U.S. Food and Drug Administration (FDA) recommended that dibutyl phthalate (DBP), an inactive ingredient in Asacol products, be removed from all drug products. In order to accommodate the FDA guidance, Warner Chilcott developed Delzicol 400 mg delayed-release capsules which do not contain DBP."

I Googled DBP and found out it is plasticizer that is a suspected endocrine disruptor (this is according to Wikipedia).

My question is, if DBP is the culprit, why would they still manufacture Asacol HD if it also contains this ingredient? Also, what impact, if any, did the patent expiration have on this?

Old Hat
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Date Joined Feb 2007
Total Posts : 4414
   Posted 4/5/2013 5:58 PM (GMT -6)   
Outrageous, and scary! In the 1980s Asacol was made by a German pharma and shipped to USA so I wonder if they also put in DBP, or is it a more recent addition? / Old Hat (32 yrs with left-sided UC; presently in remission taking brandname Colazal)

Sara14
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Date Joined Mar 2007
Total Posts : 3766
   Posted 4/5/2013 6:17 PM (GMT -6)   
Holy crap!! I received no such letter and I got my first three month supply of Delzicol in the mail today! Wow...very scary indeed. Thanks for posting!
29 years old; diagnosed pancolitis March 2007

Started first course of pred 2-19-13 (40 mg), currently on 10 mg. Asacol, 6 tabs, 2xday; Rowasa nightly; Canasa in a.m. as needed for flares; Ortho Tri-Cyclen; Singulair; Allegra; Deva multivitamin; B-12. Vegan diet.

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

Sara14
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Date Joined Mar 2007
Total Posts : 3766
   Posted 4/5/2013 6:24 PM (GMT -6)   
The bottle for Delzicol looks almost identical to the Asacol bottle, same color design and everything, just a little bigger because the capsules are bigger. Inside the capsule, theres a tablet that looks Exactly like asacol. I bet the capsules sole purpose is so they could renew their patent.
29 years old; diagnosed pancolitis March 2007

Started first course of pred 2-19-13 (40 mg), currently on 10 mg. Asacol, 6 tabs, 2xday; Rowasa nightly; Canasa in a.m. as needed for flares; Ortho Tri-Cyclen; Singulair; Allegra; Deva multivitamin; B-12. Vegan diet.

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

Sara14
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Date Joined Mar 2007
Total Posts : 3766
   Posted 4/5/2013 6:34 PM (GMT -6)   
Found a couple articles:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm215476.htm

http://www.environmentalhealthnews.org/ehs/news/prescription-drugs-can-deliver-high-doses-of-phthalates

soystud
Veteran Member


Date Joined Jan 2004
Total Posts : 4253
   Posted 4/5/2013 6:51 PM (GMT -6)   
hmmm, maybe i should reconsider ditching all drugs -
 
 
NOT !

fadoozle
Regular Member


Date Joined Apr 2011
Total Posts : 73
   Posted 4/5/2013 10:01 PM (GMT -6)   
Thanks for those links, Sara14. What's most disturbing to me is that most people on Asacol always take more than six tablets a day maximum recommended daily dose talked about in the Environmental Health News article (I have taken eight and sometimes twelve for the past two years).

According to the safety information on the FDA website, Asacol HD also contains DBP. My GI just prescribed it to me, and my assumption is that it still contains DBP unless it has been somehow reformulated. If that's the case, why is it still being manufactured? Are there plans to discontinue it as well?

Also, if the Delzicol tablet looks exactly like Asacol, is the assumption that it stills contains DBP?

Where can I find more information on this? My GI's nurse had no idea what I was talking about other than being aware that Asacol was being discontinued. She erroneously stated that Delzicol was not going to be available until the summer.

Meanwhile, what about mesalamine enemas? Do they contain DBP?

Sara14
Veteran Member


Date Joined Mar 2007
Total Posts : 3766
   Posted 4/6/2013 7:37 AM (GMT -6)   
Those are all good questions. Maybe try calling the pharmaceutical company itself. They may even have a customer service email address. I saw the Asacol HD actually had double the DBP of Asacol so I don't know why it wouldn't also be discontinued. The DBP is in the enteric coating of the tablets so I don't think it would be in the enemas.

And yes, I've been on 12 tablets a day since 2007 so I feel the same way.

fadoozle
Regular Member


Date Joined Apr 2011
Total Posts : 73
   Posted 4/6/2013 8:31 AM (GMT -6)   
Thanks for the ideas. I'm going to call the FDA and the manufacturer of Asacol HD and will report back what I discover!

sfc425
Regular Member


Date Joined Jul 2010
Total Posts : 379
   Posted 4/6/2013 8:58 AM (GMT -6)   
I'm not thrilled about this DBP info, but I think we may be overreacting. Unless you've actually noticed the side effects that are mentioned, I would guess taking Asacol/Asacol HD hasn't caused significant endocrine damage. You can get it tested to find out for sure, I guess. I'm interested in seeing how this develops but I don't think this new bit of detail should cause panic just yet.

Once again, Sara14: I don't say this because I'm doubting or questioning any of what has been discussed, I just don't think a high level of apprehension is the best approach to new information we don't fully understand yet.
28 Year Old Male. Diagnosed with UC in early 2006. Remission soon after diagnosis with treatment of Asacol. Eventually symptoms went away until mid 2010. Also living with Hiatal Hernia and GERD. UPDATE: FLARING AS OF 3/2013.

Taking: Asacol HD (2 pills, 3X daily), VSL#3 Tablets (2X day), Budesonide (3X day), Librax (1X day), Canasa (if I can!)

sfc425
Regular Member


Date Joined Jul 2010
Total Posts : 379
   Posted 4/6/2013 9:02 AM (GMT -6)   
For example: there are probably more harmful hormones injected into some of the foods we ingest on a regular basis. Not to mention contamination in water that we drink and use for bathing.

I often think about how much "healthier" I'd be if I were living in a sterilized bubble where harmful substances don't affect me, but would that necessarily lead to a more fulfilling life?

Asacol has helped many of us keep our IBD symptoms at bay. As far as I can see it has only done good for my body until something proves otherwise.
28 Year Old Male. Diagnosed with UC in early 2006. Remission soon after diagnosis with treatment of Asacol. Eventually symptoms went away until mid 2010. Also living with Hiatal Hernia and GERD. UPDATE: FLARING AS OF 3/2013.

Taking: Asacol HD (2 pills, 3X daily), VSL#3 Tablets (2X day), Budesonide (3X day), Librax (1X day), Canasa (if I can!)

sfc425
Regular Member


Date Joined Jul 2010
Total Posts : 379
   Posted 4/6/2013 9:03 AM (GMT -6)   
Sara14 said...
And I suppose you dont think DDT is nothing to worry about either? Get real. I spent all last night researching it...you just assume we all know nothing.


And you assume you know more than doctors. And get incredibly defensive whenever someone tries to extrapolate upon your panic.

sfc425
Regular Member


Date Joined Jul 2010
Total Posts : 379
   Posted 4/6/2013 9:05 AM (GMT -6)   
It really is impressive how much better you are than me. I'm also floored by your knowledge of my diet.

Are there any other aspects of my life that you can prove yourself to be better at?
28 Year Old Male. Diagnosed with UC in early 2006. Remission soon after diagnosis with treatment of Asacol. Eventually symptoms went away until mid 2010. Also living with Hiatal Hernia and GERD. UPDATE: FLARING AS OF 3/2013.

Taking: Asacol HD (2 pills, 3X daily), VSL#3 Tablets (2X day), Budesonide (3X day), Librax (1X day), Canasa (if I can!)

katarzyna
Regular Member


Date Joined Dec 2012
Total Posts : 275
   Posted 4/6/2013 9:36 AM (GMT -6)   
Children, children, take it easy. HealingWell is for support and not bickering. Some healthy debating is fine but jeesh.

No one truly knows what are put in the water, food, air, etc except those that are in charge of doing so. Even doctor's are fools half the time as they are more or less guesstimating.

sfc425
Regular Member


Date Joined Jul 2010
Total Posts : 379
   Posted 4/6/2013 9:41 AM (GMT -6)   
I'm concerned about this development, but don't think there's cause for panic. Panicking doesn't tend to help anything ever.
28 Year Old Male. Diagnosed with UC in early 2006. Remission soon after diagnosis with treatment of Asacol. Eventually symptoms went away until mid 2010. Also living with Hiatal Hernia and GERD. UPDATE: FLARING AS OF 3/2013.

Taking: Asacol HD (2 pills, 3X daily), VSL#3 Tablets (2X day), Budesonide (3X day), Librax (1X day), Canasa (if I can!)

tap
Regular Member


Date Joined May 2008
Total Posts : 446
   Posted 4/6/2013 7:50 PM (GMT -6)   
Phthalates risk isn't new news. Here is another reference that I reference in my personal medical spreadsheet.

Phthalates in Prescription Drugs: Some Medications Deliver High Doses

Phthalates and pregnancy don't seem like a good combination.

Mfargnoli3
Regular Member


Date Joined Apr 2013
Total Posts : 29
   Posted 4/7/2013 12:18 PM (GMT -6)   
I just heard about this at a conference for crohn's and colitis today. I was just diagnosed with Crohn's in the past month and haven't even finished half of my first prescription of Asacol. I am truly upset that my doctor or prescription company didn't even notify me of the upcoming change. I am worried as I am just settling into a medication, to change it. I understand that the new medicine is supposed to be the same. Doctors at the conference advised that the new capsule format will allow its ingredients to be emptied into the GI tract to promote ingestion, rather than have it excreted the same way it entered our system. Another professional recommended that she was recommending that her patient's switch to Lialda. Is anyone currently on Lialda? What are your symptoms like?

Obscure One
New Member


Date Joined Apr 2013
Total Posts : 8
   Posted 4/7/2013 6:53 PM (GMT -6)   
Hi everyone, To those who already have filled a delzicol prescription, it would be great if you could keep us informed as you switch over as to how the transition goes. I heard about this about a month ago, and already complained to the company, who refused to confirm or deny the existence of the switchover. My understanding is that there will be no generics anytime soon- I called the FDA to ask and there are no applications whatsoever to make a generic. Plus, here's this language from the Warner-Chilcott earnings call transcript: "Important to note, we continue to believe that the regulatory pathway for the approval of generic versions of ASACOL and now DELZICOL present a high bar."
See http://seekingalpha.com/article/1168351-warner-chilcott-s-ceo-hosts-2013-financial-guidance-conference-transcript?page=2.
I suspect replacing the phalate in the coating and having the coating still work properly is the problem going forward with a generic.

I transitioned easily over the years from Rowasa and Colazal to generics, but all of this has me very concerned. 9 asacol a day have kept 2/3s of my colon in remission for years- before that I was looking at a colectomy. After reading the instructions to basically take Delzicol on an empty stomach, I really wonder if the new coating is going to work that well. I haven't been able to find any human studies showing where the delzicol dissolves.

As for Asacol HD, it is not apparently bioequivalent to Asacol, as least as far as measurements of blood concentrations go, so one has to take more of it. I already get lots of reflux and a sore throat from asacol, and I am concerned that the bigger asacol HD tablets will aggravate this. I am also concerned that taking delzicol on an empty stomach will aggravate this.

Anyway, I seem to remember from that generic colazal thread that complaining to the company that made the brand caused them to change their minds and continue manufacturing it? I read it a long time ago so I could be wrong, but it seems to me it wouldn't hurt to call the company and complain about this.

Obscure One
New Member


Date Joined Apr 2013
Total Posts : 8
   Posted 4/7/2013 6:58 PM (GMT -6)   
BTW, here's an interesting thread on a board where pharmaceutical sales reps chat. They don't seem to have a lot of confidence in it.

http://www.cafepharma.com/boards/showthread.php?t=522797

UrsidaeUrsus
New Member


Date Joined Apr 2013
Total Posts : 1
   Posted 4/7/2013 8:40 PM (GMT -6)   
Unfortunately I found out that Asacol was being discontinued just as I needed my prescription refilled... I ended up getting a 15 day supply of 400 mg Asacol tablet to tide me over but I left the pharmacist really confused.

First, the pharmacist said that both Asacol 400 mg and 800 mg tablets were being discontinued. Now it's possible this woman was mis-informed because honestly she wasn't the most well-informed PharmD. But whatever...

Nevertheless, I was advised that at least in my area I shouldn't expect to see the new version of Asacol before the end of the month, and that tablets of both the 800 mg and the 400 mg Asasol were out of stock.

Given that, does anyone have a suggestion for an alternative. I looked at Pentasa - but I didn't quite understand how the dosages compared to Asacol. The only other mesasalmine product that I took before Asacol was Salofalk and apparently you can't get those tablets where I am - or Cansa (sp - which is supposed to be the US version of Salofalk).

Anyway, I have no idea, I am newly back in the US after living in Canada for 2 years and Australia before that... so I feel quite lost. Nevermind the prescription system sucks beyond belief here... sorry but...

I have moderate UC. I've taking Asacol for 5 years and it's worked very well for me. Does any one have any thoughts on alternative medications similar to Asacol - at least for the interim - until the Asacol production gets sorted out.

By the way, I am scheduled to see a new GI mid-June (who is highly recommended - and we all probably know how bad it is to have a crappy GI - so I plan to wait). But given this, my GP has no clue about UC drugs (she actually suggested that I take prednizone even though I am in remission ... I know, I know, I need a new GP). Anyway, long story short, I would like to have her call a script for me until I can get to the GI...

Thanks in advance, and sorry for the long post.

Sara14
Veteran Member


Date Joined Mar 2007
Total Posts : 3766
   Posted 4/7/2013 9:05 PM (GMT -6)   
Wow!!! Thanks all for the great information. This is outrageous! I also would like information on where in the colon Delzicol releases. I dont understand the purpose of the capsule. If you open one up, it looks like an Asacol tablet is inside. I would really like more information. I still have Asacol to last me through May but I will start Delzicol after that and post how it goes.

Ursidae -- Sorry you had a bad experience with the pharmacist. I would try to go to another one because I already got my Delzicol so some places have it already. Or you can look into Asacol HD or Lialda, these are the closest to Asacol. Canasa is a suppository. Rowasa is mesalamine enemas in the U.S. Best of luck. I agree, our medical system here is a mess!
29 years old; diagnosed pancolitis March 2007

Started first course of pred 2-19-13 (40 mg), currently on 10 mg. Asacol, 6 tabs, 2xday; Rowasa nightly; Canasa in a.m. as needed for flares; Ortho Tri-Cyclen; Singulair; Allegra; Deva multivitamin; B-12. Vegan diet.

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

Sara14
Veteran Member


Date Joined Mar 2007
Total Posts : 3766
   Posted 4/8/2013 7:42 AM (GMT -6)   
This is from the above quote pharmaceutical sales rep chat here: http://www.cafepharma.com/boards/showthread.php?t=522797

"No, Delzicol is a thinly veiled patent ploy get protect "the asset" as Roger would say. The only reason it's coming out is the Asacol coating has a carcinogenic ingredient in the coating. Delzicol is a tablet that probably won't dissolve at the TI and beyond like Asacol. Patients will either have to got to Asacol HD or switch to another 5ASA. Payers know this is a sham so it won't get the same coverage. This is the only way Warner could ever convert much volume to Delzicol becasue they've lost all support and credibly with GI's thanks to Amber's stellar leadership."

Scary!! I don't know if I should take Delzicol or request Lialda or Colazal. And who are they talking about when they say Amber?
29 years old; diagnosed pancolitis March 2007

Started first course of pred 2-19-13 (40 mg), currently on 10 mg. Asacol, 6 tabs, 2xday; Rowasa nightly; Canasa in a.m. as needed for flares; 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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