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Colazal discontinued?

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Posted 12/23/2011 9:19 PM (GMT 0)
There is no stool conditioner listed on Colazal's active ingredients.

Watson was never FDA licensed to make the drug. Salix made both pills and watson sold the exact same pill as authorized generic. Stopped in at the pharmacy today and the pharmacist looked it up. Both Watson sold and Salix brandname have CZ on the gelatin capsule. Totally against the law to sell a different formulation with the same pill marking. He told me that both companies have stopped shipping the drug and he bets that it is permanent. They stocked only the roxanne generic at the store and sold 10 times as much as the brandname. He has had fewer complaints than with asacol. He also told me that one company could be making all the balazalside in the US then placing it is coded pills for the other licensees.

Apriso is not balasazide but a mesalamine with a new and different delivery system


Doing my internet research, Roxanne followed by Mylan sound like much more trustworthy companies than Salix/Watson. Salix is about speculating and making the big score. Roxanne and Myaln are generic makers looking for long term business.

The list of possible inactive ingredients(roxanne) is pretty long:

ammonia
silicon dioxide
FD&C Blue No. 1
FD&C Red No. 40
FD&C Yellow No. 6
gelatin
ferrosoferric oxide
isopropyl alcohol
magnesium stearate
butyl alcohol
propylene glycol
shellac
titanium dioxide

One way to get some of those out would be to use the alternative dosing method of dumping the powder onto apple sauce and tossing the gelatin capsule.
Posted 12/24/2011 1:55 AM (GMT 0)

 Actually Salix doesn't really manufacture any of their product, all of their production is subcontracted out.  They do the research, testing etc, then subcontract for the ingredients, capsule, binders, etc.  Salix authorized Watson to sell Colazal (balsalazide Disodium) as a generic.  You MIGHT be right about one company producing balsalazide Disodium, that does happen a lot in the drug industry.

 Watson quit selling Colazal around Nov 2009 (unprofitable).  Salix stopped their production (actually subcontracted production) around Oct 2011, in anticipation of Giazo.  The Roxane generic may be good for most patients (I hope it is), but it didn't work for me.  I'll be trying the Mylan generic soon.  Then go from their.

 Balsalazide Disodium converts to Mesalamine in the colon.

Post Edited (gastro60) : 12/23/2011 8:59:29 PM (GMT-7)

Posted 12/24/2011 5:22 AM (GMT 0)
Ammonia & shellac are used as fillers in the Roxene generic? YUCK!!!!!!!!!!!! / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/24/2011 4:51 PM (GMT 0)
 Yeah, a little scary.  I can't find any of the inactive ingredients for the Mylan generic, but it really doens't matter because I'll be trying it, and I'm not going to call them.  The Roxane and Mylan generics are both Orange in color, where the Colazal was beige, so maybe the Mylan generic has similar ingredients as Roxane?

 Either way you can tell that the inactive ingredients in Colazal was different.

 

Posted 1/2/2012 5:25 AM (GMT 0)
It's kinda hard to greet the New Year optimistically with this hassle confronting us ... still no new info online RE Giazo as far as I can tell. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/6/2012 1:00 AM (GMT 0)

 Old Hat, I agree about the optimism.  Giazo is still slated for Feb 17 (depending on FDA).  If Giazo isn't approved then, there is a chance that Salix will start producing Colazal again.  I can only hope!  In the meantime, through a little tenacity and a good pharmacist I was able to get another bottle of Colazal shipped in from out of State.  Evidently there are still a few bottles scattered around the country in distrubution centers.  Have your pharmacist check with their distribution center, and/or other pharmacy centers.  And if your pharmacist is reluctant to check another pharmacy center, go to another pharmacy.

Posted 1/6/2012 1:50 AM (GMT 0)
i though I as doing good on the generic but I guess not. Started flaring yesterday.....UGH!!!!
Posted 1/6/2012 2:26 AM (GMT 0)
 Which generic, Roxane, or Mylan???

Posted 1/6/2012 5:47 AM (GMT 0)
Gastro60, where are you located? In my area the pharmacies started getting bad news RE Colazal from their warehouses in October. I'm trying not to freak out over this, but the generic must be full of chemical dyes since users report its color is bright orange. Sounds problematic for many of us ... / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/6/2012 6:16 PM (GMT 0)

 Old Hat, I'm located in Michigan.  I can't believe I got the last bottle, there has to be a few more scattered around????

 Yeah the coloring is sure different between the generic's and the brand.  I'm curious on which generic "ash'smom" is using?? 

Posted 1/6/2012 8:51 PM (GMT 0)
Thanks, Gastro60. Meanwhile, I just heard from Advocacy for Patients with Chronic Illness that Salix continues to blame our problem on the FDA for not approving Giazo w/o clinical trials! Advocacy says also that nothing can be done about cessation of brandname Colazal production at this point-- because there is no law on the books applicable to such cessation. So outrageous a situation & we are stuck with it!!!!!! / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/8/2012 4:59 AM (GMT 0)
I was Mylan. And yes it is BRIGHT ORANGE. A bottle came open and a few busted and it was a MESS. it stained my counter tops. The amount from just one pill could color 5 gallons of water.
Posted 1/8/2012 5:21 AM (GMT 0)
I wish doctors would urge the pharmas to remove chemical dyes from IBD meds, especially. Being hypersensitive to a lot of substances, we really don't need additional exposure thru bright-colored capsules. In general, though, mesalamine itself tends to stain yellow-orange. Several threads have been posted on this forum over the yrs discussing how it stains toilet seats, bedsheets, etc. when our poop containing this med leaks onto them. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/8/2012 7:40 PM (GMT 0)

 I was afraid you'd say Mylan.  Roxane didn't work for me, so Mylan will be the one I'll be trying next (probably won't work for me either) if Salix doesn't come out with something in Feb.  I can't believe the FDA gave approval for Roxane and Mylan generics.  Although you will hear that a lot of patients are doing OK on them????  I'm Glad for them!!

Posted 1/11/2012 7:47 PM (GMT 0)
Just signed up at this forum and can relate to the frustrations you have with regard to discontinuation of brand Colazal--I just ran out and started taking Roxane generic today, but am sceptical of it since I tried a generic in 2009 and was sick most of that year, hoping Roxane generic is a better drug.  I tried Pentasa for 5 years, but started losing my hair, so I'm apprehensive about taking Apriso samples that my Dr. gave me yesterday, will hold off these.  Wishing all of us the best with medications for UC.  My Dr. started me on yogurt a few months ago, but I switched to acidophilus pills to reduce costs. 
Posted 1/12/2012 2:55 AM (GMT 0)
I am not on Colazol now, but I was doing well on it from about 2005 to 2007. My mail order pharmacy switched me to those bright orange generic capsules. I can't remember all the dates, but I am wondering if that is why I had a terrible flare and ended up on Remicade.
Posted 1/12/2012 7:56 AM (GMT 0)
UPDATE: Doors12, where are you? Salix has finally listed an e-address for their product info call center-- [email protected] --finally on their Website under Colazal!!!!!!!!!!!! Needless to say, I fired off a very irate e-mail to them complaining about the way they just stopped Colazal production without any advance warning. Now is our chance to tell them what we've been writing here about our shock and distress at their irresponsible conduct ... / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/13/2012 12:38 AM (GMT 0)

 I hope everybody jumps on that Colazal website!  There's also an FDA drug shortage site (you can find it through Google) that people can send e-mails too.  You can also have the FDA send a "Med Watch FDA form 3500", and then fill out the "Adverse Event" listing in "other" "Drug Shortage", then fill in some of the detail about the Colazal drug shortage.

Posted 1/13/2012 1:03 AM (GMT 0)

 Gingerbear, good luck on the Roxane generic!  Most likely the generic you tried in 2009, was either Mylan, or Roxane?  That Pentasa you were on is similar to Asacol, and a friend of mine with UC has been using Asacol for about 4 years now with no problem (it's one of the drugs I've kept in the back of my mind if I'm forced to try something different).  Although what works for one person may not work for another.

 Dr J, I haven't heard about Remicade, but after looking it up I see it takes a totally different approach than "Balsalazide Disodium" or "Mesalamine".  I guess it's supposed to be a "TNFa" blocker!  How are you doing on Remicade?

Posted 1/13/2012 3:14 AM (GMT 0)
Hey Old Hat,

I have been busy lately, as you may have seen on another thread, I've been experiencing some REALLY positive success going gluten free...I really need to post a thread on it here, as I'm sure I'm not the only UC'er who this can benefit! The thread I already posted on this was something like "Gluten intolerance/Wheat Belly/ beers" or something like that.

Anyway, I am a little confused about the salix email you mention -- so we now have a way to complain directly? I like this information, but I am very busy, but I will be back on HW this weekend and will check this stuff out and see if I can join the effort. I have only about probably 2-3 more weeks of brand name Colazal left, and I have a GI appointment coming up. I would be more paniced had I not found some success with this gluten free diet! I am having almost all movements formed and other ibs symptoms are going away, joint pain is much better...it's really been rather wonderful. I will post my story with the gluten free thing (so far) this weekend.

I'll be back
yeah
Posted 1/13/2012 5:21 AM (GMT 0)
Gastro60-- thanks for FDA info! Glad you're feeling better, Doors12-- if you are gluten-sensitive then it definitely makes sense to alter your diet. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/16/2012 4:48 AM (GMT 0)
See Rey's interesting comment on CCFA & the drug co. reps in her thread "Colonoscopy needed?" / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/16/2012 5:24 AM (GMT 0)
OldHat, I read the thread. Drug reps on the sidelines. I think I found out all I needed to know when going gluten free after about 7 years of hell has so far made a SIGNIFICANT improvement in my subjective health state. The fact that I had to discover this on my own, with no suggestions from the doctor or CCFA kind of tells me how useful the CCFA is. I'll just stop there before I mention *** on a boar or something equivalent. I did see a NIH clinical trial on gluten, closing the barn door after the horse is let out.
Posted 1/16/2012 8:46 PM (GMT 0)
Yes, the gastros will likely jump on gluten now-- because they can't blame everything on vitamin D deficiency. I'm getting to feel pretty cynical about this collusion between gastros, big pharmas, & non-profits which claim to take the patients' side. We are on our own in this mess called IBD-- most of the time. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 1/18/2012 4:26 AM (GMT 0)
Old Hat, I just took advantage of the email address you provided. I think I only have about 12 Colazal pills remaining before I will have to switch to the generic. I have no idea "which" generic it is, what is the easiest way to tell?
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