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Colazal discontinued?

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Posted Yesterday 5:08 AM (GMT 0)
My real question is why did they discontinue so suddenly and without warning? I hope they didn't find out it causes kidney failure or cancer or something horrible like that.

I couldn't get any answers over the phone
Posted Yesterday 10:46 PM (GMT 0)
I contacted Advocacy for Patients with Chronic Illness about this problem we now have. Jennifer Jaff there replies that she is contacting CCFA about it & will let me know if they find out more than we've heard to-date. JJ thinks we need a group behind us at this point as individual inquiries just get the Salix run-around. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted Yesterday 11:11 PM (GMT 0)
Good thinking Old Hat, thanks for doing that.

Keep us posted if you hear anything please
Posted Today 2:39 AM (GMT 0)
Good job, old hat!
Posted 12/3/2011 1:34 AM (GMT 0)
GidHike, you might want to e-mail JJ yourself-- to explain what you are experiencing with the Salix Patient Assistance Program for Colazal. You can find her contact info on the Advocacy Website. Also, my gastro complained to Salix in recent days & they replied that they expected to have Giazo out on the market already, but the FDA has delayed that. Ha! Further proof that all they care about is their profit margin ... nuts to that!!!!!! / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/3/2011 5:50 PM (GMT 0)
Another UC med??? And it's also the same as Colazal. I bet it's just rebranded Colazal so that they get more money - because they're probably losing money to generic CZ
Posted 12/4/2011 8:21 PM (GMT 0)
From the bit of info about Giazo that I found on the 'net, it is a tablet whereas Colazal is a capsule. Also, it was planned to be (2010 data) 1.1 grams of med each, whereas Colazal is 750 mg. each. So that may translate to fewer pills required daily than with Colazal. In any case, it's extremely irresponsible of Salix to discontinue brandname Colazal w/o prior warning. Apparently they pushed the FDA to approve Giazo w/o requiring clinical trials 1st. I assume their argument is that chemically it is the same compound as Colazal; that's what they just told my gastro. But I'm wondering how/where a tablet will dissolve ... as recent research shows that the delivery mechanism for getting mesalamine to the site of inflammation is the most important factor in healing it. I hate it that they expect us to just wait and see-- when many of us have insurance issues besides. My Rx goes thru Medco; I doubt that they'll rush to cover the cost of Giazo from its Day 1 on the market! They only cover brandname Colazal for me because my gastro submits an annual request called "prior authorization". Now is the time for us to submit such a request for 2012 coverage, but we are still in the dark about which med will be available ... Grrrrrrrrr! / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/7/2011 8:17 AM (GMT 0)
Still no new info on Salix Website or CCFA. In fact, under "Product Ordering" for Colazal, Salix advises to consult a wholesaler, then lists 24 of them. So helpful ... blast them!!!!!!!!! / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/9/2011 3:00 PM (GMT 0)
Medco is filling my name brand colazal w/ generic. Ugh. I tried it in the past and it didn't work as well. Have GI appt. next week will see what he says.
Posted 12/10/2011 8:48 PM (GMT 0)
I've been on the generic for a while along with 6MP and it has worked well for me. I also consider it my maintenance drug as 6MP has been the most help.
Posted 12/10/2011 10:30 PM (GMT 0)
Yup, UCers on 6MP, Imuran, or Remicade who also take generic balsalazide do not seem to have issues with it-- because the immunosuppressant is their main help. Meanwhile, I have asked at local pharmacies about the possibility of getting my brandname 280-bottle: Walgreens says NONE available at their warehouses, CVS says to check back on Monday. SALIX PHARMACEUTICALS IS THE PITS FOR DUMPING ON US THIS WAY!!!!!!!!!!!!!!!!! Grrrrrrrrrrrrrrrrrr! I wish I could punch out their board of directors! They couldn't care less about UC & how it messes with our lives when uncontrolled. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/13/2011 5:07 AM (GMT 0)
FYI, all concerned: CVS pharmacy told me today that their warehouses are out of brandname Colazal. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/14/2011 10:24 PM (GMT 0)
medco had been sending me brand name for over a year and suddenly switched to generic. I had to take it since I didnt have anything else and am doing well on it. Im glad since I wont be getting brand name from anyone. I would definately sign a petition though because I agree it is negligent to the patients not to tell them far enough in advance to make other arrangments. I for see some lawsuits from people who go into a flare due to not having their medication.
Posted 12/15/2011 5:54 AM (GMT 0)
Which generic did Medco send you, Ash'smom? Mylan, Roxene, or Watson? I am interested to know because the Watson generic made me sick. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/21/2011 8:09 PM (GMT 0)

confused  've currently been on brandname Colazal for 8 yrs, and have been symptom free.  A little history on Colazal: The Colazal brand was approved by the FDA on July 18, 2000.  Around Jan 2008, Watson, Apotex, Roxane, and Mylan were approved to produce generic balsalazide disodium.  Watson entered into an agreement with Salix to produce an exact copy of Colazal (Salix provided all ingredients and capsule).  Around Nov 2009, Watson quit producing Colazal (it wasn't profitable enough).  Around Nov 2010, Apotex (Canadian Co) quit producing their version of balsalazide (to much competition, wasn't promoted, not profitable enough).  Roxane and Mylan are the only companies left producing a generic balsalazide.  Their version has the same active ingredients (but could legaly be in the 80% range), with different fillers, coloring, and capsule.

Salix was in the process of coming out with their new enhanced Colazal, called Giazo, which would reduce the dosage from 9 pills per day, to 2 per day.  This was tentatively set for FDA approval around October 2011.  Salix discontinued the production of Colazal based on their new drug, and now the product pipeline for Colazal has pretty well dried up.  I realize a company is in business to make a profit, but by discontinuing a product that still has a purpose, and is needed by thousands, is morally wrong.  I think Salix's decison to eliminate Colazal is going to be detremental to their profit margin, and their public relations.  It's a disaster to Salix, and to the thousands of patients that rely on Colazal.  And it just makes me mad (I'm saying this in a nice way).

When the generics came out my insurance forced me to try the Roxane version, which didn't work for me, so my Gastro gets prior authorization for the brand name.  I have enough Colazal left to get me through the holidays then I'll have to try the Mylan version.  If that doesn't work????   We're all in the same boat.

Posted 12/21/2011 9:49 PM (GMT 0)
Thanks for additional info, Gastro60. From my own experience taking the Watson generic, I do not believe it was the exact chemical copy of brandname Colazal. It gave me beastly headaches at the base of my skull, which I never EVER had before in my life! The Watson generic capsules did, however, look exactly like brandname Colazal. The brandname med was unique among oral mesalamine meds in that, per my gastroenterologist, it contained a stool conditioner. Therefore, it was a huge improvement over Dipentum, the 1990s new oral 5-ASA. I'm especially interested to hear that you find the Roxene generic problematic, too. It's so outrageous that we are forced by Salix to "test" alternatives to brandname Colazal-- at considerable risk to us of flaring anew!!!!!!!!!!!!! This is totally a case of corporate profit taking precedence over patients' safety. No matter what they boast about Giazo, we have no guarantee that (1) it will work as well for us as brandname Colazal AND (2) that those of us with RX insurance will be able to obtain timely coverage for Giazo. Generics can be an absolute pain in the butt! (I'm being polite.) In fact, the New York Times health topics section reported a couple yrs ago that generics have been found problematic for cardiac patients, epileptics, and people afflicted with depression-- in clinical studies. Why don't doctors scream about this? / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/21/2011 10:20 PM (GMT 0)
I had a feeling that at least one of the generics was being made by the same company as made the brandname colazal. Salix was making the Watson generic under agreement. Explains why discontinuing one ended the making of another. Watson was in a marketing agreement to sell Salix's manufactured drug as a generic.

www.wikinvest.com/stock/Salix_Pharmaceuticals_%28SLXP%29/Product_Supply

Salix and Watson have connections with members of there board and both companies manufacture generic drugs for others.

said...
"Fri Dec 28, 2007 11:07pm GMT

Dec 28 (Reuters) - Salix Pharmaceuticals Ltd (SLXP.O) said Watson Pharmaceuticals Inc (WPI.N) will market an authorized generic of its anti-inflammatory drug, Colazal.



The term "authorized generic" as used in press releases on the rool out of Watson generic means the drug is made by Salix:

wikipedia said...


"Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients; whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are required to contain only the identical active ingredients as the brand. Authorized generics compete with generics on price, quality and availability in the generic marketplace, and are marketed to consumers during and after what is commonly known as “the 180-day exclusivity period”. In June 2009 the FTC issued an Interim Report that found that drug prices are lower when authorized generics are marketed against a single generic drug than when they are not. The report showed that with authorized generic competition during the 180-day marketing exclusivity period, retail drug prices are on average 4.2 percent lower than the pre-generic branded price, and wholesale drug prices are on average 6.5 percent lower than the pre-generic branded price.



I would think that the FDA or Mylan would be able and willing to supply exact information on any possible ingredient differences between there generic and the brandname.
Posted 12/21/2011 11:09 PM (GMT 0)

 Old Hat, and AZYooper, you both have a lot of knowledge there.  And you're right, none of us know if Giazo will work as well.  The new tentative release date for Giazo is Feb 17, 2012.  But the FDA could change that.

What Salix did by stopping production of Colazal is inexcusable.  Even if Giazo does work, it probably won't for everyone, and it will still take time to get prior authorization.  Bottom line: either the Roxane, or the Mylan generic should work for half or better, and the rest of us will have to expierment with other medications.  I can see some rough patches coming up in the future.

And to think that Salix's mission is to improve the lives of people with gastric disorders giving patients the most effective solution in gastroenterology..   Yup!

Maybe when this is all over with, everyone will have found other alternatives and Salix will no longer be needed..

Post Edited (gastro60) : 12/23/2011 12:50:30 PM (GMT-7)

Posted 12/22/2011 5:16 AM (GMT 0)
Gastro60-- about 10 days before Doors 12 started this thread, I had posted one called "Possible Colazal glitch?" In that thread some other members of this forum replied stating that Salix has gotten into trouble in recent yrs with 2 other G/I products of theirs, Osmo Prep & Xifaxan. This is worrisome because, among other reasons, Salix gives financial support to prominent gastroenterologists in the U.S. as well as to the CCFA, which is supposed to be a patient advocacy organization. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/22/2011 1:25 PM (GMT 0)
I just checked and they sent me Mylan generic. I have 1/2 bottle of Colazal so we shall see!
Posted 12/22/2011 8:11 PM (GMT 0)

 Old Hat -- That doesn't really surprise me about Salix.  I won't have enough Colazal to make it until Feb 17 (for the tentative release of Giazo), so I'll have to try the Mylan generic, and then go from there.

Apriso is another drug that Salix manufactures, and it is also balsalazide Disodium, but the delivery system is different, and so are the fillers, etc..  I might give Lialda (Asacol) a try if nothing else works.   Just don't know ????

 Pink 1 --- Hope Mylan works for you

Posted 12/22/2011 8:29 PM (GMT 0)
RE fillers in Apriso: 1 of them is Aspartame! That was brought up here on the forum while Fruitgirl was a moderator & also starting out on Apriso. She contacted Salix to ask why they would put an artificial sweetener into a med for IBD patients, who can react badly to that stuff. Salix gave her some flip answer that it was just a very tiny amount of sweetener used because the Apriso pills are large & may be hard to swallow. Baloney! Apriso also obviously has a good amount of dye in it as color is bright blue. (I'm allergic to something in it.) / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
Posted 12/22/2011 11:25 PM (GMT 0)

 Old Hat --- Thanks for the heads up on aspartame.  I didn't really want to try Apriso (Salix) anyway.

Posted 12/23/2011 1:30 PM (GMT 0)
Old Hat - what is a stool conditioner? I have never heard of that term before...
Posted 12/23/2011 8:44 PM (GMT 0)
Niro-- in this context it's a secondary ingredient added to brandname Colazal-- to help firm the stools & thereby reduce frequency of bms daily. In my experience it does help with that, but can be dehydrating-- so a UCer taking such med needs to drink plenty of water during waking hours. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)
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