Asacol discontinued

[my little penguin]

The guidance notes that other regulatory initiatives have been implemented to limit exposure to DBP and DEHP. In 2009, Europe banned their use in cosmetics after identifying them as reproductive toxicants, while the US Congress blocked their use in children's toys at concentrations higher than 0.1% in 2008.

"While it is recognised that drug products may carry inherent risks, DBP and DEHP are used as excipients, and safer alternatives are available," says the FDA in its new document, which acknowledges that human toxicity data is scanty at the moment.

"Therefore, the Agency recommends avoiding the use of DBP and DEHP as excipients in [regulated] drug and biologic products."

Pharmaceutical manufacturers can look for alternative excipients in the FDA's Inactive Ingredients Database, and the listings for DBP and DEHP in this repository will be removed once manufacturers reformulate products that contain them.

from:
http://www.pharmafile.com/news/171935/fda-warns-against-phthalate-use-medicines

So it will probably be removed from ASACOL HD once they have an alternative.

 

[my little penguin]

In one case, the man taking Asacol for his ulcerative colitis, an inflammatory bowel disease, had a concentration of a dibutyl phthalate (DBP) metabolite in his urine measuring nearly 17,000 parts per billion, according to a case study reported by the Harvard/CDC team. The average for the general population was 46.

from:

http://www.environmentalhealthnews....on-drugs-can-deliver-high-doses-of-phthalates

 

[my little penguin]

:ymad::ymad:

http://ntp.niehs.nih.gov/ntp/htdocs/ST_rpts/tox030.pdf

FDA study from 1995---

 

[my little penguin]

.However, repeated exposure to certain phthalates, including DBP and DEHP, in animals has been associated with various adverse effects—notably the disruption of the development of the male reproductive system.

Exposure to DBP has been shown to cause decreased sperm counts in male animals and reduced fertility in both female and male animals. Exposure in pregnant animals has resulted in fetal skeletal malformations and decreased anogenital distance in the male offspring. Adverse effects on the male reproductive system have been seen in several species, including rats, mice, and guinea pigs. Exposure to DEHP has shown similar adverse effects as DBP on the male reproductive system.

Although the current available human data are limited, the Agency has determined that there is evidence that exposure to DBP and DEHP from pharmaceuticals presents a potential risk of developmental and reproductive toxicity. It is also recognized that safer alternatives to DBP and DEHP are available. Therefore, the Agency has recommended avoiding the use of DBP and DEHP as excipients in CDER- regulated drug and biologic products. These recommendations apply to CDER-regulated drug and biologic products that are under development (INDs), non-application products (OTC) monograph products, and both marketed approved products and those currently under review for marketing consideration (NDAs), (ANDAs), and (BLAs).

from:
http://www.drugregulations.org/2012/12/new-fda-guidance-limits-use-of.html

 

[my little penguin]

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1241971/pdf/ehp0112-000751.pdf

 

[my little penguin]

Some ortho-phthalates, including di(2-ethylhexyl) phthalate (DEHP) and di-n-butyl phthalate (DBP), have been identified as reproductive and developmental toxicants in laboratory animals (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlFoster 2005; The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlHowdeshell et al. 2008). Similar effects have not been reported in animals exposed to diethyl phthalate (DEP); however, limited human studies have suggested a possible association between DEP exposure and male reproductive health outcomes (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlSwan 2008). Studies have shown widespread population exposure to background levels of phthalates (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlSilva et al. 2004). Of concern, particularly high exposure levels may result from orally ingested medicinal products containing phthalates as inactive ingredients. For example, increased urinary concentrations of phthalate metabolites were first reported for an individual taking a mesalamine product (Asacol; Warner Chilcott Pharmaceuticals Inc., Mason, OH) (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlHauser et al. 2004) and later confirmed for individuals taking mesalamine and other drug products (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlHernández-Díaz et al. 2009). High urinary concentrations of phthalate metabolites have also been identified in patients with cystic fibrosis who used pancreatic enzyme products (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlKeller et al. 2009). This has led to increased interest in identifying additional drug products that contain phthalates as inactive ingredients.

Inactive ingredients (excipients) are defined as “any component other than the active ingredient in a drug product” (FDA 2011). These various compounds may be used in drug formulations for a number of functions related to the preparation and stability of the physical dosage form or the delivery of active ingredients (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlRowe et al. 2009). Excipients used in specialized drug product formulations may permit a) localized availability of active medications in various sections of the gastrointestinal (GI) tract, b) controlled release of a medication over time, or c) through the skin. Phthalates, in combination with various polymers, may be used as plasticizers and film coating agents in orally ingested solid pharmaceutical dosage forms and in numerous types of modified-release drug delivery systems such as enteric-coated and delayed-release tablets, pelletized delayed-release capsules, enteric-coated capsules, and controlled-release transdermal films (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlAllen et al. 2005).

Several different phthalates are currently used as excipients in approved pharmaceutical formulations: diethyl phthalate (DEP), dibutyl phthalate (DBP), dimethyl phthalate (DMP), dioctylphthalate (DOP), hypromellose phthalate (HMP), cellulose acetate phthalate (CAP), polyvinyl acetate phthalate (PVAP), and polyethylene terphthalate (PET) [Food and Drug Administration (FDA) 2010b]. These compounds are not themselves technically “approved” for general use as excipients; rather, they are permitted to be included in their corresponding approved drug products, with maximum levels designated for each type of dosage form and route of administration (The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlOsterberg and See 2003; The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlSteinberg and Silverstein 2003). The maximum amount of DBP used in specific FDA-approved drug products ranges from 1.70 mg for a delayed-action, enteric-coated tablet formulation to 11.18 mg for an extended-release capsule product. DEP has been approved at amounts ranging from 0.5 mg for an uncoated, chewable tablet to 16.8 mg for a delayed-action, enteric-coated capsule (FDA 2010b).

from:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3295354/

 

[eddievalleytrailer]

I'm new here. This Asacol thing got me looking around and I found you guys. Anyway, my GI put me on Balsalazide Disodium. Now I feel like I have a sunburn!!! Especially on my hands. I had a similar reaction to sulfasalazine years ago. The Asacol has done just fine for the last 13 yrs or so, now they go and change it. I wonder if they know how much this effects our lives? It's not like Red Lobster taking "Shrimp and Lobster Pasta" off the menu (man, I miss that stuff). This is causing a real bump in the road for me and lot of others who have these diseases. I'll call my GI today and ask for...what, sunscreen?

 

[2thFairy]

Welcome to the forum! I would ask your doctor for Delzicol or Lialda to try since it sounds like you are having an allergic reaction to the balsalazide disodium.

 

[lvail@twcny.rr.com]

The FDA approved the new drug on Friday. I can't imagine they pulled Asacol off the shelves before the alternative was available. From what I understand a prescription called in now will be denied but maybe they will honor the refill for a few days.

The main thing is anyone on it needs to get their doctors to prescribe Asacol HD as a half dose or get the new drug.

I have been on Asacol since 1986 and it has been a good treatment for me. Now I have to take Delzicol which is hard to swallow, sticks in my throat, and oddly enough I have had 2 Crohn's attacks since I started on this drug.It is also $40 more for a 90 day supply. Go figure??:

 

[Sarah50]

I have been on Asacol since 1986 and it has been a good treatment for me. Now I have to take Delzicol which is hard to swallow, sticks in my throat, and oddly enough I have had 2 Crohn's attacks since I started on this drug.It is also $40 more for a 90 day supply. Go figure??:

What about asking your doctor for Asacol HD 800? That's what I am on now because my doctor wasn't sure about Delzicol. I'm only taking 2 pills a day, because I understand that it is not equivalent to Asacol 400 - which I used to take 6 pills a day with that. Anyway, I'm still not having any problems whatsoever so I'll stick with Asacol ... for now.

 

[eddievalleytrailer]

Well, my Dr. called in Delzicol which my insurance promptly denied I called them and asked "Would you rather pay for a hospital stay and a bunch of blood transfusions?" Doesn't matter, it is on the "not covered" list. They said to try Apriso or Lialda. I thought that was my Dr's job. You know, to prescribe the drug to best suit my needs. Anyway, I called my Dr only to find out he is on vacation for the rest of the month. It's a good thing I have a few bottles of Asacol put aside for just such an occasion. Anyone have any experience with Apriso or Lialda?

 

[Kathyhamilton]

When using Asacol I was taking 3 pills twice a day. Went to pick up Delzicol, it says 2 pills 3 times daily, what a pain. Anyone else taking Delzicol twice a day? I have a very hard time finding a time to take them because I eat 6 small meals a day(empty stomach, hardly ever)

 

[eddievalleytrailer]

Here is a quick update on the sunburn effect I got from the balsalazide disodium. I just kept having the burning sensation in my hands and feet. Sounds crazy, I know. Well, guess what...now, a week after taking balsalazide disodium, the skin on the ends of my fingers is peeling off, just as if it had been burned. It's crazy how a medicine can cause a burn?

 

[Dexky]

Eddie, was Asacol HD not an option. My son was switched to that nearly two years ago. We weren't even made aware of the switch. Just went to pick it up one day and got those instead. Were basically told one 800mg HD was = 2 400mg Asacol. My son's been on em ever since with no negative reactions or anything. Asacol is not his only med by a long shot so I can't really say it's effective.

 

[kh216]

I am on Lialda and it works fine for me. It is a bigger pill. One Lialda pill is the equivalent of 2 Asacol HD pills. You would need to check with your doctor about the dosage you need.

 

[eddievalleytrailer]

Eddie, was Asacol HD not an option. My son was switched to that nearly two years ago. We weren't even made aware of the switch. Just went to pick it up one day and got those instead. Were basically told one 800mg HD was = 2 400mg Asacol. My son's been on em ever since with no negative reactions or anything. Asacol is not his only med by a long shot so I can't really say it's effective.

HD is not covered by my insurance. I have some regular Asacol left, so I am taking that until I get over my sunburned hands. I want to start Apriso on a clean slate. My Dr gave me samples of the Apriso to try.

 

[Grouchy]

When using Asacol I was taking 3 pills twice a day. Went to pick up Delzicol, it says 2 pills 3 times daily, what a pain. Anyone else taking Delzicol twice a day? I have a very hard time finding a time to take them because I eat 6 small meals a day(empty stomach, hardly ever)

I too take 3 pills twice daily. And I am doing the same on Delzicol with no problems after a couple of months. I'd bet you could revert to 3 twice a day as well.

 

[Ronpur]

Well, my Dr. called in Delzicol which my insurance promptly denied I called them and asked "Would you rather pay for a hospital stay and a bunch of blood transfusions?" Doesn't matter, it is on the "not covered" list. They said to try Apriso or Lialda. I thought that was my Dr's job. You know, to prescribe the drug to best suit my needs. Anyway, I called my Dr only to find out he is on vacation for the rest of the month. It's a good thing I have a few bottles of Asacol put aside for just such an occasion. Anyone have any experience with Apriso or Lialda?

I ended up getting Apriso. I have been using it for a month now. I take 4 of them in the morning. So far, it has been working. And it seams slightly better than Asacol was. I kept having issues with the Asacol not even opening by the time it passed through me. No prolems with Apriso so far. My pharmacy was able to find a discount from Apriso's manufacturer which gave me the first copay free and $10 after that. Much better than what I paid before for asacol. My doctor and I are both pleased with the results so far!

 

[eddievalleytrailer]

My Dr. gave me a weeks worth of samples of Apriso but I don't want to start it until I am over the reaction I had to the balsalazide disodium. I am going to my family Dr. to see what I can do about my hands. They are killing me!! Some parts are peeling for the third time!! I have resorted to using super glue to keep them from bleeding. The skin just keeps peeling off. I want to start Apriso on a clean slate so I am using my Asacol reserves until I get this sorted out.

 

[fievel1079]

I'm concerned about the Asacol coating and the phthlate reports about possible health risks. My dad took Asacol for 18 years, up until its discontinuation, and I took it for 16 years before switching to Lialda a few years ago. My dad developed both Type II diabetes and low testosterone while on the medication. Has anyone else experienced these complications while taking Asacol? For women on Asacol has anyone had any pregnancy complications?

 

[Kathyhamilton]

To those of you now taking Delzicol, are you taking 3 twice a day or 2 three times a day?

 

[cha]

Went to refill my rx and received the replacement Delzicol. I've been taking asacol for 18 years. learned more on this forum than at my drug store. it's a holiday and I couldn't get my Dr. Thanks everyone!

 

[Grouchy]

To those of you now taking Delzicol, are you taking 3 twice a day or 2 three times a day?

While in remission I take 3, twice a day (6). When I get a flare (not very often) I will up the dosage to 3, three times a day (9) for a few weeks. It works for me. This is the same as I did for several years on Asacol.

Having said that, I think taking 2 three times a day is probably preferred. It should keep the medicine in your system longer if taken every 8 hours instead of every 12 hours.

 

[sinsmailbox]

I've been taking medication for my Ulcerative Colitis since 2006. I had no insurance and the medication is crazy expensive. I went online and found a generic through a Canadian pharmacy, as someone previously mentioned. I'd been using those for 3+ years and never had a problem. Buying in large amounts is cheaper too. I could get 1,000 (400) tablets for $389 + $10 shipping and that would last me about 5 1/2 months. Buying one month of Asacol here is $400+.

 

[Supernova1990]

I'm still able to get my Ascaol 400mg x8 a day... wonder if it's different for us across the pond here in the UK! I'll mention this to my consultant. These Delzicol meds don't sound that nice!

 

[trebor-HI]

Anybody know...are the various forms of oral mesalamine equivalent? The only other mesalamine my insurance will cover is Apriso. Seems like they're all designed to dissolve in the ileum.

 

[PtAdvocateforAsacol]

You're right that it's expensive, kh216! With insurance I pay $75 a month for Asacol. Without insurance, I believe it'd be over $500 (going by memory, don't have the info in front of me). I just looked it up, and with my insurance I'd also be paying $75 per month if I switched to Delzicol. It looks like it'd be the same cost for Asacol HD too. So at least I won't be paying any more, but I sure would like to pay less as $75 each month is not cheap. (I also take Nexium, Ranitidine, and Amitriptyline - and generic Zofran as needed - so with those added in I pay over $100 each month just for prescriptions).

Hi! I am a patient advocate for a patient who has Crohn's disease in his small intestine. The Asacol was working so well for him and now the 800mg is not covered by his insurance and he is paying out of pocket about $400 a month. Can someone give me some insight as to what insurances are covering the Asacol so I can assist this patient?

 

[prplkow]

I commented in another post, but I have Aetna and my copay is $60 for my Asacol.

 

[Sarah50]

Hi! I am a patient advocate for a patient who has Crohn's disease in his small intestine. The Asacol was working so well for him and now the 800mg is not covered by his insurance and he is paying out of pocket about $400 a month. Can someone give me some insight as to what insurances are covering the Asacol so I can assist this patient?

I have Health Net insurance and pay $30 at Walmart for my Asacol 800 HD prescription, take 2 a day and am still doing very well on it.

 

[Lallx4]

I was on Asacol for yrs until it was replaced with Lialda. I started Lialda in May/June. Around July/August my hands, feet, joints etc. were so swollen & sore so I went to a specialist (thought maybe I had Arthritis). The Dr. did lots of blood work & xrays found nothing told me to go for PT. August I started getting a rash on my legs thought maybe I had sun poisoning ( I had been in Aruba for 3 wks). By October it was getting worse burning, itchy and now on my stomach, upper legs & back. I finally went to a Dermatologist was told I had Eczema and was given a Steroid cream. It did help with the burning but the rash is still there.
This past Friday I had a headache and another scratchy throat ( the 4th since Sept). Since I work at a school I thought nothing of it until one of the women that I work with said how long ago did you start that new medicine? So I googled side effects for Lialda. BINGO everything that I have been dealing with was listed as a side effect. So I called my GI and he called in a prescription for Asacol HD DR 800 MG tablets!! My original Asacol 400 mg I was taken 4 pills a day that's 1,600 mg. This new prescription Asacol HD 800 mg he has me taking 3 tablets 2 x a day that's 4,800. The amount doesn't add up to what I originally taking! I wonder why?

 

[jrogers]

So I'm surprised that no one (but me, I guess) has looked inside the Delzicol capsules. It's an Asacol caplet in a capsule. The capsules protect the patent, not the medicine.

Asacol, Asacol HD and Delizcol are all manufactured by Warner Chilcot De. Gmbh. (Since I am new to this list, I can't post the URLs of the regulatory sheets, but you can find them by searching for asacol-info.pdf, AsacolHDPrescribingInfo.pdf and pi_delzicol.pdf) While the Asacol variants are licensed from Medeva Pharma Suisse AG and the Delzicol is not, that seems to only be because Medeva owns the trademark on Asacol. Note that the Delzicol regulatory sheet explicitly states that the clinical studies it cites were conducted with "mesalamine delayed-release tablets" (that would be Asacol) and that Delzicol is bioequivalent. I would guess so.

Up until the end of 2010 (at least) Asacol was manufactured by Procter and Gamble under license from the same Swiss company. Then for a while it was manufactured by a smaller Ohio company. Now it's imported. P&G likely got out when the patent was about to run out.

The only good things I can say about Asacol is that it works and, unlike other mesalamine drugs, doesn't make me sick. So I live with Warner Chilcot just as I live with UC.

As for dosage, I've had prescriptions both for 2x3 Asacol tablets a day and 3x2 Asacol tablets. I don't even know what the Delzicol prescription actually says. I use 2x3 because it's more convenient and works.

May you all have a flare-free New Year.

 

[jrogers]

A follow-up after reading some more of the regulatory sheets. It appears that the non-bioequivalence between Asacol and AsacolHD is because less of the mesalamine in the AsacolHD shows up in the blood (36% lower maximum blood concentrations with 1x800mg HD vs. 2x400mg regular). This is probably a good thing, but whether it is or is not depends on how the mesalamine works and that no one knows. (We know only that it does. Good magic is magic that works.)

So is the HD phthalate free? I rather doubt the Delzicol is. But none of the data sheets list out the excipients. Maybe the Ohio/Germany move was to avoid falling astray of the FDA recommendation.

 

[2thFairy]

So I'm surprised that no one (but me, I guess) has looked inside the Delzicol capsules. It's an Asacol caplet in a capsule. The capsules protect the patent, not the medicine.

You aren't the only one, nor the first one, to look inside the Delzicol capsule. Others on this board have done this and reported it in other threads. Have a look around the board. There is a lot of good information here.

 

[jrogers]

You aren't the only one, nor the first one, to look inside the Delzicol capsule. Others on this board have done this and reported it in other threads. Have a look around the board. There is a lot of good information here.

Indeed they have. I apologize for not having tracked that thread ("Asacol HD question") down before sounding off.

Thanks,
JRogers

 

[Cin]

Hello!! I was wondering if anyone is taking another med that is similar to Asacol, but much cheaper? I understand that generic Asacol was discontinued and Delzicol is the new drug, but I currently do not have insurance and it is quite expensive. Is there any help out there to get your meds? Asacol 800 mg is priced at Target for 180 tablets at $900 and Delzicol is between $250-300! Just thought I may ask. Thank you!!!

 

[kh216]

I take Lialda. I don't know how much it costs because I am on a prescription drug plan. However, I think it works just as well as Asacol HD.

 

[jrogers]

I'm paying 410$US for 180 400mg Delzicol. I don't recall exactly how much I was spending on Asacol, but the version that continues to be marketed in the US is the HD version, which appears to have been released primarily for patent protection. So it would not be at all surprising for it to be very expensive.

Lialda looks like a interesting alternative. It, like Asacol, is delayed release, which seems to reduce systemic exposure to the mesalamine (which makes me sick as a dog). Does anyone have a sense of how much this costs (pre-insurance)?

(Don't think I'm permitted to post URLs. This is an ordinary http URL)
dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7

Thanks,
JRogers

 

[dave13]

My GI wanted me to take pentasa.Extremely expensive on my plan.Asacol was listed in the formulary as a less expensive alternative.Did he mean Asacol HD if Asacol is discontinued? I'll ask him to clarify.I'll ask about Lialda as well.

 

[2thFairy]

I'm paying 410$US for 180 400mg Delzicol. I don't recall exactly how much I was spending on Asacol, but the version that continues to be marketed in the US is the HD version, which appears to have been released primarily for patent protection. So it would not be at all surprising for it to be very expensive.

Lialda looks like a interesting alternative. It, like Asacol, is delayed release, which seems to reduce systemic exposure to the mesalamine (which makes me sick as a dog). Does anyone have a sense of how much this costs (pre-insurance)?

(Don't think I'm permitted to post URLs. This is an ordinary http URL)
dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7

Thanks,
JRogers

Lialda was about $800 a month before insurance when I was taking it 4 years ago.

 

[chanas09]

Is there any significant difference between the asacol HD 800 and the old asacol 400?

 

[Snickerdoodle]

I am currently an asacol dependent Crohnie who has been out of meds for over a week. My insurance company is being completely retarded about giving me the replacement drug, delzicol. Even with a peer to peer, which is the last step in the appeals process, they told my doctor that I have to try Lialda, Pentasa, and Apriso first and fail it before they will give the delzicol. I am in a state of utter shock. Why would they risk a hospital stay? The drugs both cost the same. I've been on asacol with success for 3 years. Now I am flaring and starting Lialda tomorrow, even though it releases in the small intestine and my disease is now concentrated in the large intestine only. What should I expect from Lialda? Anyone on it please let me know what to look out for in terms of side affects!

 

[2thFairy]

Now I am flaring and starting Lialda tomorrow, even though it releases in the small intestine and my disease is now concentrated in the large intestine only. What should I expect from Lialda? Anyone on it please let me know what to look out for in terms of side affects!

Lialda releases in the colon. The side effects should be no different from Asacol, since they are both mesalamine.

Good luck to you! I hope this change doesn't screw up everything for you.

 

[Snickerdoodle]

Just an update...been on Lialda for about 3 weeks now and feel like crap. I'm only awake at this crazy hour because I have such terrible joint pain that I cant sleep. I want my Asacol back!!!

 

[IBD is a pain in the a$$]

It's all nice that everyone is sharing info & their personal experiences but what can be done to get the pharmis to stop this roller coaster ride we must endure, and potential health sacrifices, so that they can continue to reap high profits? How can this practice be changed? Class action? FDA complaints? Where can the consumer turn to for protection?

 

[Snickerdoodle]

At this point, I have tried Lialda, Pentasa, and Apriso. All with terrible side affects. My GI anyway said those all release in the small intestine and since my disease is primarily in the colon, they aren't really medically the right answer for me. Asacol was working just fine until they decided to rename it and put a capsule on it. So, I have been controlling my IBD with just Humira, which thank G-d is still paid for by my insurance. I have no idea what other recourse there is, since I've been thru 3 different meds that failed and have made appeals to the insurance company each time with the help of my GI. That is simply where it ends...if you want a certain med they won't cover, then you need to miraculously come up with the money to pay for it. So, most of us who do not come from odles of money end up doing without. At this point I'm doing relatively ok, considering I'm now 9 weeks pregnant and need to be off of my prilosec too. It wouldn't be the right time for me to fight to get back onto the Asacol/Delzicol anyway since I'm trying to get away with being on the least amount of medication necessary during the pregnancy, but if that wasn't the case and I really found that I needed the Asacol/Delzicol, I'd probably be pitching a fit daily.