Asacol discontinued. What now?

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 Asacol 400 mg has been replaced by Delzicol 400 mg.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

Lialda is 1200mg. I switched to Lialda from Asacol and I've been doing well. Maybe it would be your best option.

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.

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?

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

AZYooper I think you are exactly correct

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?

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.

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.

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?

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)

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.

Keep is posted LindyLoo! I'd like to know that too.