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Crohn's Disease Forum » Treatment » 5-ASA/Mesalamine » The Asacol replacement


04-20-2013, 09:33 PM   #1
Kathyhamilton
 
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The Asacol replacement

So, I go to the Pharmacy to pick up my new prescription of Delzicol, which replaced the discontinued Asacol. They are capsules that feel a little heavy. I shake one of them and it felt like a tiny marble in it. I open the capsule and inside is what looks like the exact Asacol I was taking, but no writing on it. I don't get it, I thought they were changed because of the coating? Looks like the same coating as the old one in the gel capsule. Called Warner chilcott, but they are closed for the weekend.
04-20-2013, 11:30 PM   #2
CrohnsChicago
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I actually spoke with a rep from Warner Chilcott today at a Crohn's Education Symposium. The capsule is the only difference according to them. The medication inside is still the same.

Check out this thread for an ongoing discussion on the topic.
http://www.crohnsforum.com/showthread.php?t=49793
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Crohn's-Colitis May 2012
Current Meds:
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06-11-2013, 02:19 PM   #3
safarigirl
 
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What I have learned: 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."
06-11-2013, 10:02 PM   #4
kh216
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However, I find it interesting that this FDA withdrawal request comes out just as the Asacol's patent is about to expire and then other companies could have made generics of it. My GI doctor told me that Warner Chilcott went to FDA to recommend that Asacol be withdrawn so that they could make more money off of Delzicol, their new brand name drug.
06-11-2013, 10:11 PM   #5
Kathyhamilton
 
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very maddening, I've been watching this drug for two years, waiting for it to go generic.
06-11-2013, 10:38 PM   #6
safarigirl
 
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Trust me NOT defending drug companies (ugh) but I believe all meds with that compound in it were removed from the market, not just Asacol...for whatever that's worth...
06-12-2013, 06:04 AM   #7
kh216
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Then I raise another question. Check out this link:

http://foodconsumer.org/7777/8888/D_...on_Drugs.shtml

If researchers were concerned about DBP back in 2004, why wasn't Asacol withdrawn from the market then? I took this product for many years, thinking it was safe.
06-12-2013, 06:30 AM   #8
PVail
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God thats just shocking, DBP . it is very concerning that some of us are on this drug long term and no one has mentioned any long term side effects , especially any Forums. As a commonly used drug should my GP know this information . Should he not be concerned that my symptoms change or I feel worse or I dont get any better . Am i in fact supplementing one poison for another .
So at the moment I take Asacol and Omeprazole . Am i at risk because of this DBP ?
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06-12-2013, 06:48 AM   #9
kh216
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I'm glad I switched to Lialda. I was on Asacol HD and now I wonder if Asacol HD still uses this additive?
06-12-2013, 07:08 AM   #10
kirkland
 
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Yea, wouldnt asacol hd contain this ingredient as well?
06-12-2013, 08:30 AM   #11
safarigirl
 
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Horrifying. I was pregnant while taking a lot of Asacol:

"In one study of male infants, increasing prenatal exposure to background levels of phthalates was associated with a decrease in the distance between the anus and base of the penis, indicating incomplete male reproductive development "

I have a son. Who also has Crohn's (incidentally...). I have UC and my husband has Crohn's. Dr told us child would have 50% chance of IBD -- we assumed we'd be in the "other" 50%. He is doing very well though. He was diagnosed at 5. Now 7. Loves sports....no change in lifestyle. Active as everyone else even more so. Few stomach aches from time to time. But I do worry of course......takes 3 meds (sulfasalazine, cipro, and 6mp in liquid form,).
01-02-2014, 09:48 AM   #12
jrogers
 
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So, I go to the Pharmacy to pick up my new prescription of Delzicol, which replaced the discontinued Asacol. They are capsules that feel a little heavy. I shake one of them and it felt like a tiny marble in it. I open the capsule and inside is what looks like the exact Asacol I was taking, but no writing on it. I don't get it, I thought they were changed because of the coating? Looks like the same coating as the old one in the gel capsule. Called Warner chilcott, but they are closed for the weekend.
CrohnsChicago said:
I actually spoke with a rep from Warner Chilcott today at a Crohn's Education Symposium. The capsule is the only difference according to them. The medication inside is still the same.
kirkland said:
Yea, wouldnt asacol hd contain this ingredient as well?
So, yeah. I did the same thing as Kathyhamilton, did a little research (it's in the thread quoted by CrohnsChicago) and came to the conclusion that the WC rep confirmed. I'm not sure the company rep is actually a reliable source with respect to this. They may have been simply reassuring a continuing customer.

The exterior capsule could be pH dependent as well, which might limit the absorption of phthalate in the upper GI, but it would still be there in the gut. I did not find anything in the regulatory sheet citing studies on blood levels of phthalates.

So does anyone know if the coating has actually changed. Other than the exterior capsule the big change that came at the same time that Asacol was discontinued was that WC moved production to Germany.

What's needed is transparency. But if there was transparency then pharmaceuticals would not be the cash cow the industry it is. (Compare promotional costs to development costs.)
10-17-2014, 06:26 PM   #13
Mkars01
 
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I'm hoping for advice. I have had UC for over 20 years and have been mostly in remission due to a steady dose of 2400mg of Asacol per day. I have been taking this medication and dose for 20 years and my company prescription plan has decided not to cover Asacol any more. They also won't cover Delizicol. I tried sulfasalazine 20 years ago and had an allergic reaction. What is my best alternative for long term daily usage to replace Asacol?
10-18-2014, 12:46 AM   #14
Justanothercp
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I had to switch to Lialda. No problems.
10-18-2014, 02:57 PM   #15
jrogers
 
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Trust me NOT defending drug companies (ugh) but I believe all meds with that compound in it were removed from the market, not just Asacol...for whatever that's worth...
I think the point is that Delzicol is manufactured in Germany. The response to the FDA order seems to have been to reformulate Asacol HD and move production of Asacol in a trivially different physical form offshore.

Both changes have no apparent pharmacological motivation. A loophole in the regs? Hard to believe that German pharma laws would be more tolerant than the US. But maybe WC doesn't market it in Germany. A trival patent extension strategy? Well, it sure seems convenient, but Asacol HD came on the market well before they withdrew Asacol. (Didn't you get cupons from the manufacturer?) There's nothing concrete to base a guess on and the drug companies sure aren't talking while the flavor lasts.

OTOH, the difference between Asacol and other mesalazine formulations was the pH selective coating. That made it the only oral therapy I could tolerate. Is the DBP essential to the action of the coating? Can't be absolutely necessary if Asacol HD does not include it. But, then, maybe the renewed patent isn't truly trivial.

I'm old and my children have moved on. I avoid phtalates when I can. But in this case the risk/benefit goes to the Delzicol side. (But that really ticks me off.)

--jrogers
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