Announcement

Collapse
No announcement yet.

Zelnorm recalled!!!!!!!!!

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • Zelnorm recalled!!!!!!!!!

    I was taking Zelnorm for my IBS and I went to get it filled this week, and come to find out it has been recalled since March! I still don't know why. I wonder what it could do to me. Now I don't know what to do about my constipation issues.

    Mrs. Ridings


    I was on...
    Loestrin 24(to prevent period induced flares)
    Elmiron since Feb.'07 for a year and half
    Atenolol for Migraines(caused by elmiron) since June '07(Had to have the amount doubled)
    Tried Prevacid didn't work.
    Tried Axert for migraines didn't work.
    Tried Frova for migraines made worse.
    Atarax Feb.'07-Feb'08
    Used to take IBS meds of all kinds, now I use Yerba Mate guayaki drinks, eating lots of fiber and flax seed, and taking probiotics and added magnesium. My probiotics help w/ flares too.


    Now for the occasional flare related to stress, I take probiotic eleven and marshmallow root and it will make it stop and Im fine again. Otherwise I dont have many problems w/ my severe IC like I used to.Thank God!

    Find the good in all things and then
    anticipate the good so that you may enjoy it.


    (KJV)Psalms 37:
    3 Trust in the LORD, and do good; so shalt thou dwell in the land, and verily thou shalt be fed.
    4 Delight thyself also in the LORD: and he shall give thee the desires of thine heart.
    5 Commit thy way unto the LORD; trust also in him; and he shall bring it to pass.

  • #2
    My suggestion would be to ask your doctor.

    Sending encouraging hugs,
    Donna
    Stay safe


    Elmiron Eye Disease Information Center - https://www.ic-network.com/elmiron-p...mation-center/
    Elmiron Eye Disease Fact Sheet (Downloadable) - https://www.ic-network.com/wp-conten...nFactSheet.pdf

    Have you checked the ICN Shop?
    Click on ICN Shop at the top of this page. You'll find Bladder Builder and Bladder Rest, both of which we are finding have excellent results.

    Patient Help: http://www.ic-network.com/patientlinks.html

    Sub-types https://www.ic-network.com/five-pote...markably-well/

    Diet list: https://www.ic-network.com/interstitial-cystitis-diet/

    AUA Guidelines: https://www.ic-network.com/aua-guide...tial-cystitis/

    I am not a medical authority nor do I offer medical advice. In all cases, I strongly encourage you to discuss your medical treatment with your personal medical care provider. Only they can, and should, give medical recommendations to you.
    [3MG]

    Anyone who says something is foolproof hasn't met a determined fool

    Comment


    • #3
      I'm with Donna, call your doctor pronto!
      Hugs,
      Tracey
      How do you eat an elephant? One bite at a time...

      Harry arrived 2/23/09!



      *IC Volunteers are not medical authorities nor do we offer medical advice. In all cases, we strongly encourage you to discuss your medical treatment with your personal medical care provider. Only they can, and should, give medical recommendations to you.

      IC Diet Cheat Sheet:
      http://www.ic-network.com/diet/2009icdietlist.pdf



      Dx's:
      IC dx'd Nov 2004
      Lymphocytic Colitis dx'd July 2005
      Possible IBS
      Current IC Meds
      Vistaril 25mg in the evening
      Previous IC Meds taken:
      Cystoprotek - 2 caps 2x's a day
      Elmiron, 100mg 3x's a day
      Ditropan, 5 mg 3x's a day
      Others:
      Wellbutrin 150mg 2x's a day for Anxiety/IBS
      Pepcid 40mg a day for GERD
      Zytrec for Nasal Allergies
      Align Probiotic daily for IBS

      Comment


      • #4
        Yes, it was recalled a few months back. That is too bad, since it did help alot of people. Maybe they will come up with something else to help with the IBS/constipation.
        Jen

        Comment


        • #5
          Have you tried Miralax? You could ask your doctor about it. It has been helping me with the constipation lately. I do not have IBS per say, just that my whole gut is slooooow.
          Jen

          Comment


          • #6
            It was recalled I believe for causing irregular heart beat and I think reading heart attacks in some patients. I too took it on occasion, about twice a month. My dr. told me to take stool softners if I had not gone in a couple days, that usually works. Good Luck.

            Comment


            • #7
              I agree, it's worth it to try the Miralax. I've got severe constipation problems even though I've got Crohn's disease which causes extreme pain and diarrhea. I can't win for losing. The miralax works with BOTH constipation and diarrhea by leveling out the amount of water in the large intestine. It's also sold over the counter now. It's about 10-15 dollars for a 14 day dose bottle, but its worth it. If you don't want to spend that, try good old Milk of Magnesia!
              *IC-- Summer 2004; PFD--October 2005
              *Fibro--Fall 2000; CFS-- Fall 2000
              *MPS--Fall 2000; Crohn's disease-- 1997*IBS,GERD, *Migraines, hypothyroidism, GYN problems *Degenerative Disc Disease/scoliosis

              Total Abdominal Hysterectomy--adenomyosis--9\08

              04/17/09 Crohn's disease almost killed me with a combo of extreme constipation from pain medications. My bowel ruptured, I almost died from peritonitis and spent several days in the ICU then more in a private room on the floor. If you have any questions about severe constipation from pain meds please don't hesitate to send me a message.

              Comment


              • #8
                I love Miralax! I used to take Zelnorm and it gave me cramps sometimes so Miralax works better for me. The only thing that bothers me is that the bottle says not to take longer than 7 days. My gyn told me to that it's safe to take longer than that but it still makes me wonder. Anyone have any thoughts on taking every day? I'm afraid to stop.
                3/06 IC symptoms began immediately after endometrial ablation procedure called NovaSure
                5/07 IC diagnosed by cystoscopy with hydrodistention finally after 14 months of doctor's appointments and pain

                Medications: Elmiron since 8/07, Atarax, Synthroid & Cytomel for low thyroid, Lisinopril for high blood pressure, Xanax for anxiety as needed, Vitamin D 50,000 units once a week

                Supplements: MSM/glucosamine, Quercetin, Desert Harvest Aloe Vera, Flora Biotic 16, Magnesium, Citracal, B-complex

                What's worked: IC diet, physical therapy for pelvic floor dysfunction, TENS, rescue instillations and acupuncture

                Comment


                • #9
                  I've taken it on and off for years, and my gastroenterologist gave me a years RX for it without requiring me to even get a followup appointment. It's safe, but if you have worries talk to the pharmacist at your drug store. It's like the prilosec OTC, it says don't take longer than 14 days, but I'm on the prescription dose of it, and I take it every day, 2x a day. It's just one of those things that's ultimately up to your doctor.
                  *IC-- Summer 2004; PFD--October 2005
                  *Fibro--Fall 2000; CFS-- Fall 2000
                  *MPS--Fall 2000; Crohn's disease-- 1997*IBS,GERD, *Migraines, hypothyroidism, GYN problems *Degenerative Disc Disease/scoliosis

                  Total Abdominal Hysterectomy--adenomyosis--9\08

                  04/17/09 Crohn's disease almost killed me with a combo of extreme constipation from pain medications. My bowel ruptured, I almost died from peritonitis and spent several days in the ICU then more in a private room on the floor. If you have any questions about severe constipation from pain meds please don't hesitate to send me a message.

                  Comment


                  • #10
                    Zelnorm to be Made Available to US Patients Under Restricted Access Program

                    Here is an article, I rec. in one of my medical subscriptions. Thought it might help someone who had to stop taking it, and couldn't find an alternative med. If I posted this in the wrong place, please let me know. Thank you.

                    ads


                    Zelnorm to be Made Available to US Patients Under Restricted Access Program

                    -- FDA approves limited treatment IND program for Zelnorm

                    http://pharmalive.com/news/index.cfm...&newsletter=1#

                    EAST HANOVER, N.J., July 27, 2007 /PRNewswire/ -- In cooperation with the US Food and Drug Administration (FDA), Novartis has established a restricted access program for Zelnorm(R) (tegaserod maleate) so that patients in need of this medicine can be considered for treatment.



                    The program, called a treatment IND, is designed to help women in the US under 55 years of age who suffer from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and for whom no other treatment has provided satisfactory relief and/or patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment for IBS-C or CIC. Novartis and the FDA are moving forward with this program because of requests from physicians and patients following the marketing suspension of Zelnorm in March 2007.

                    Treatment INDs are generally used to allow restricted access to medications for patients in need if no comparable alternative drug or therapy is available to treat the disease. Patients given access through a treatment IND must meet specific FDA-approved criteria for enrollment.

                    Through the program, appropriate female patients with IBS-C or CIC who are assessed by their physicians as being in critical need can have access to Zelnorm for relief of the often painful and disruptive symptoms associated with these conditions. The program protocol and consent materials are designed to ensure that patients and physicians are fully informed of the potential risks and benefits of Zelnorm.

                    To be considered for access to Zelnorm through the treatment IND, patients must have IBS-C or CIC and meet the specific criteria in the treatment IND protocol. To become part of the treatment IND, patients should contact their physicians to inquire about the protocol and evaluate if they meet the criteria. For further details of the program's protocol, physicians can call 866-248-1348 or 888-669-6682 or go to www.zelnorm.com.

                    For patients who do not meet the criteria of the treatment IND but have an urgent need for Zelnorm based on a life-threatening or severely debilitating condition, there may be an alternative option available through the FDA. Physicians may inquire about this potential access option by contacting Novartis at (888-NOW-NOVA) or the FDA CDER Division of Drug Information at 301-827-4570 or www.fda.gov/cder.

                    Novartis suspended US marketing and sales of Zelnorm as a result of an FDA request in order to permit further discussion of its benefit/risk profile. This decision was based on a review of a new retrospective analysis of pooled clinical trial data which showed that the incidence of cardiovascular ischemic events was higher in patients taking Zelnorm than in those taking placebo. However, no causal relationship between Zelnorm and cardiovascular ischemic events has been demonstrated.

                    Novartis has extensively studied Zelnorm and believes that this medicine provides important benefits for appropriate patients. Novartis is in discussions with the FDA to better understand the findings and to determine appropriate next steps.

                    IBS is a disorder characterized by abdominal pain or discomfort, bloating, and altered bowel function. An estimated 12 million Americans suffer from IBS with constipation. Many have symptoms for five to 10 years, which trigger missed work days and often prevent them from participating in everyday activities with their family and friends. Chronic constipation accounts for more than 5.7 million constipation-related outpatient visits each year, with more than 990,000 visits to emergency rooms and more than 580,000 to hospital outpatient facilities. It leads to more than 282,000 in-patient hospitalizations with constipation as the primary diagnosis.

                    Disclaimer

                    The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "to be," "continues," "can have," "may," "believes" or by express or implied discussions regarding potential future regulatory filings, approvals or future sales of Zelnorm. Such forward-looking statements reflect the current views of Novartis regarding future events and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any future regulatory filings will satisfy regulatory requirements regarding Zelnorm, that Zelnorm will be brought back to market in the US or any additional market or that Zelnorm will reach any particular level of sales. In particular, management's expectations regarding Zelnorm could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including additional analysis of clinical data, or unexpected new clinical data, as well as the additional risks and factors discussed in Novartis AG's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

                    About Novartis

                    Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

                    Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.pharma.us.novartis.com.

                    Novartis Media Contacts

                    Anna Frable
                    Novartis Pharmaceuticals Corporation
                    862-778-5388 (Office)
                    732-673-5262 (Cell)


                    Karen Sutherland
                    Novartis Pharmaceuticals Corporation
                    862-778-0323 (Office)
                    917-330-5981 (Cell)

                    [email protected] [email protected]

                    CONTACT: Anna Frable, +1-862-778-5388, or cell, +1-732-673-5262,, or Karen Sutherland, +1-862-778-0323, or cell,+1-917-330-5981, , both of NovartisPharmaceuticals Corporation [email protected] [email protected]

                    Web site: http://www.pharma.us.novartis.com/ht....fda.gov/cder/

                    Ticker Symbol: (NYSE:NVS)




                    Originally posted by mrsaridings View Post
                    I was taking Zelnorm for my IBS and I went to get it filled this week, and come to find out it has been recalled since March! I still don't know why. I wonder what it could do to me. Now I don't know what to do about my constipation issues.

                    Comment


                    • #11
                      Thank you everyone for the advice, I seem to be alright since I've been off of it. Knock on wood. I drink a hot cup of tea or have an herbal tea Guayaki, that seems to help when it does bother me.

                      Now if I could just get these bleapin migraines under control I'd be alright.
                      Mrs. Ridings


                      I was on...
                      Loestrin 24(to prevent period induced flares)
                      Elmiron since Feb.'07 for a year and half
                      Atenolol for Migraines(caused by elmiron) since June '07(Had to have the amount doubled)
                      Tried Prevacid didn't work.
                      Tried Axert for migraines didn't work.
                      Tried Frova for migraines made worse.
                      Atarax Feb.'07-Feb'08
                      Used to take IBS meds of all kinds, now I use Yerba Mate guayaki drinks, eating lots of fiber and flax seed, and taking probiotics and added magnesium. My probiotics help w/ flares too.


                      Now for the occasional flare related to stress, I take probiotic eleven and marshmallow root and it will make it stop and Im fine again. Otherwise I dont have many problems w/ my severe IC like I used to.Thank God!

                      Find the good in all things and then
                      anticipate the good so that you may enjoy it.


                      (KJV)Psalms 37:
                      3 Trust in the LORD, and do good; so shalt thou dwell in the land, and verily thou shalt be fed.
                      4 Delight thyself also in the LORD: and he shall give thee the desires of thine heart.
                      5 Commit thy way unto the LORD; trust also in him; and he shall bring it to pass.

                      Comment


                      • #12
                        How to get Zelnorm

                        You can still order Zelnorm online at www.medsmex.com

                        The name there is Zelmac. It is totally legit but takes about a month to arrive.

                        It is still packaged from Novartis, the maker of Zelnorm. I think it is about $45.00 for 30 pills.

                        You can still get them from Mexico because the FDA does not control drugs there. Zelmac is the same thing as Zelnorm, it just has a different name South of the Border!

                        Good Luck,
                        Hope that helps!

                        I could not live without my Zelnorm. I got a tip from the medical profession on how to get it when it was dicontinued. It has been a lifesaver for me with my IBS

                        Comment

                        Working...
                        X