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FDA Orders Novartis To Pull Zelnorm Ads       10/07/03 11:25 PM Edit Reply Quote Heather Reged: 12/09/02 Posts: 7799 Loc: Seattle, WA FDA Orders Novartis To Pull Zelnorm Ads June 30, 2003 WASHINGTON (AP) -- The government says an ad campaign implies a drug for irritable bowel syndrome works far better than it really does, and ordered Zelnorm's maker to stop the advertising. The Food and Drug Administration cited ads by Novartis Pharmaceuticals that pictured a smiling woman and said, "Novartis and Gloria ended 30 years of debilitating abdominal pain, bloating and constipation in just three days." While the ad doesn't mention Zelnorm's name, it discussed a "treatment from Novartis" that is "beating IBS." The ad implies Zelnorm cured Gloria and could help millions of women when in fact it's not a cure, doesn't work in just three days, and helps only a very small proportion of patients, FDA officials wrote Novartis on Friday in ordering such ads to immediately cease. "The ads are messages of hope based on true patient experiences," that let people know they should ask doctors about new treatments, said Novartis spokesman Greg Baird. The ads run periodically and aren't running now, but Novartis will discuss FDA's concerns with agency officials, he said. Zelnorm was approved last summer to treat women with one form of irritable bowel syndrome, the type associated with constipation. In studies FDA stressed at the time, patients fared only a little better -- 5 percent to 10 percent better -- when taking Zelnorm than when taking dummy pills. web page -------------------- Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook! Print     Remind Me     Notify Moderator

Entire thread Pharmaceutical Heather 07/14/03 01:50 PM Medical Marijuana Significant for Migraines, Fibromyalgia, and IBS Heather 02/16/21 01:21 PM Heartburn drugs that are proton pump inhibitors could trigger IBS and SIBO Heather 12/07/20 01:28 PM For IBS Patients, Cannabis Linked to Fewer Rehospitalizations Heather 05/05/20 02:14 PM Cannabis could help a person defecate Heather 04/14/20 12:17 PM FDA OKs Reintroduction of Tegaserod (Zelnorm) for IBS-C in Women Under 65 Heather 04/04/19 02:45 PM Long-term cannabis use increases risk for IBS Heather 10/19/17 04:04 PM FDA approves new drug for chronic constipation Heather 01/26/17 03:05 PM Mixed Opioid Agent Adds to Growing List of Therapies for IBS-D Heather 01/27/16 02:48 PM Low-dose naltreoxone for the treatment of irritable bowel syndrome Heather 01/26/16 01:20 PM Amitiza benefited patients with chronic idiopathic constipation Heather 02/10/15 04:15 PM Medical Marijuana for Digestive Disorders: High Time to Prescribe? Heather 09/17/14 02:08 PM Antibiotics Early in Life May Boost Obesity Risk Heather 08/18/14 03:13 PM Antidepressants, psychological therapies effectively treated IBS Heather 07/15/14 02:49 PM Proton pump inhibitor (acid reflux drugs) may cause heart disease Heather 09/23/13 03:22 PM Older drugs are better than new ones Heather 06/13/13 02:00 PM On Anti-Depressants? Some Raise Risk of C. Diff Infection Heather 05/13/13 05:51 PM Heartburn drugs, NSAID painkillers use linked to IBS symptoms Heather 03/18/13 01:24 PM FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation Heather 08/31/12 11:25 AM 3-month FDA delay for potential IBS drug linaclotide Heather 04/23/12 01:45 PM Latest FDA watch list includes GI drugs Heather 04/23/12 01:42 PM Antibiotics that reduce gut bacteria linked to obesity Heather 05/06/11 12:25 PM Rifaximin: a unique gastrointestinal-selective antibiotic for enteric diseases Heather 02/10/11 10:23 AM Antacids increase risk of pneumonia Heather 01/14/11 04:35 PM Editorial - Antibiotic Rifaximin (Xifaxan) Therapy for the Irritable Bowel Syndrome Heather 01/07/11 03:01 PM Antiobiotic Rifaximin (Xifaxan) for Patients with Irritable Bowel Syndrome without Constipation Heather 01/07/11 02:59 PM Proton Pump Inhibitor Drugs Tied to 80% Increase in Clostridium difficile Risk Heather 11/10/10 11:29 AM Phase 3 clinical trials of linaclotide for IBS constipation Heather 10/13/10 02:44 PM An over-the-counter drug for constipation offers superior symptom relief compared with a commonly used prescription agent Heather 07/16/10 03:17 PM Benefit/risk ratio of Renzapride not sufficient to warrant further study in IBS-C Heather 04/07/10 01:32 PM Adverse effects of drugs on small intestine and colon Heather 03/16/10 11:23 AM Children's Belly Aches Don't Disappear With Antidepressant Heather 03/11/10 01:14 PM Survey: Marijuana Use In Patients With IBS Heather 01/12/10 03:17 PM FDA Approves Amitiza for IBS-C Heather 05/23/08 10:59 AM Zelnorm no longer available except for emergency use Heather 04/11/08 12:05 PM Clinical trial: phase 2 trial of lubiprostone for irritable bowel syndrome with constipation. Heather 02/15/08 11:20 AM Role of Antibiotics vs Conventional Pharmacotherapy in Treating Symptoms of Irritable Bowel Syndrome Heather 01/03/08 04:45 PM FDA permits the restricted use of Zelnorm Heather 08/09/07 11:41 AM Antidepressant Therapy (Imipramine and Citalopram) for Irritable Bowel Syndrome Heather 06/20/07 01:56 PM Neuromuscular Dysfunction and IBS: Clinical Implications for Drug Use Heather 02/04/07 04:30 PM Enteric Bacteria and IBS Heather 11/26/06 02:51 PM Rifaximin vs Placebo in Reducing Symptoms in Adults With IBS Heather 11/26/06 02:39 PM Antibiotic Rifaximin Appears Safe and Effective for Irritable Bowel Syndrome Heather 10/26/06 10:29 AM Citalopram (Celexa) Improves Symptoms of Irritable Bowel Syndrome Heather 10/14/06 12:57 PM Marijuana eases chronic pain Heather 07/17/06 11:49 AM Doctors group launches war on drug ads Heather 07/17/06 11:17 AM New IBS drug in development in Japan Heather 07/05/06 05:13 PM Marijuana and the gastrointestinal tract Heather 06/12/06 03:38 PM Zelnorm Rejected Again in Europe Heather 04/02/06 03:25 PM Antidepressants for IBS Heather 03/16/06 12:31 PM Takeda Laxative Wins U.S. Approval for Adults Heather 02/18/06 01:36 PM Cilansetron: ; Solvay Pharmaceuticals suspends registration activites in the U.S., Heather 01/18/06 04:15 PM Hearburn Drugs Cause Diarrhea Heather 01/08/06 05:10 PM Zelnorm fails to win EU panel backing Heather 12/21/05 11:25 AM Non-steroidal anti-inflammatory drugs and gastrointestinal damage Heather 12/08/05 12:51 PM Octreotide May Be Effective in Treatment of Nonconstipated IBS Heather 12/08/05 12:31 PM Lack of Lasting Effectiveness of Miralax Laxative Treatment of Constipation. Heather 08/07/05 04:18 PM Acute Hepatitis Associated With Lotronex Heather 07/24/05 02:37 PM FDA revisions to safety labeling for Lotronex (alosetron ) Heather 05/22/05 06:46 PM Clinical pharmacology of new motility promoting agents Heather 05/22/05 06:33 PM Rationale for Using Serotonergic Agents to Treat Irritable Bowel Syndrome Heather 05/08/05 06:21 PM Zelnorm Associated With Rare Cases of Severe Diarrhea, Ischemic Colitis Heather 04/24/05 03:48 PM Clinical Response to Tricyclic Antidepressants in Functional Bowel Disorders not Related to Dosage Heather 03/28/05 01:32 PM Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS Heather 02/19/05 05:56 PM Irritable Bowel Syndrome Medications Side Effects Survey Heather 11/09/04 02:04 PM On the Relationship Between Colon Ischemia, Irritable Bowel Syndrome, and Serotonergic Therapy of Irritable Bowel Syndrome Heather 10/24/04 07:10 PM New Risk Information on Zelnorm for IBS for Women Heather 07/11/04 02:18 PM The Relationship among Previous Antimicrobial Use and H. Pylori Infections Heather 06/27/04 01:33 PM Therapeutic benefits of cannabis in migraine, fibromyalgia, irritable bowel syndrome Heather 06/04/04 03:54 PM Pharmaceutical companies funding a number of studies into IBS in the UK Heather 05/25/04 12:00 PM Irritable bowel syndrome helped by Paroxetine, a drug for depression Heather 05/10/04 02:15 PM Fears cause low sales of Lotronex Heather 05/10/04 01:46 PM Zelnorm Warning Issued by FDA Heather 05/10/04 01:01 PM Renzapride Improves Symptoms in Constipation-Predominant Irritable Bowel Syndrome Heather 12/01/03 06:14 PM Clinical Trial Guidelines for Pharmacological Treatment of IBS - Pharmacological Options Heather 12/01/03 05:55 PM SOLVAY presses ahead with cilansetron, a new IBS drug Heather 11/18/03 03:43 PM Measuring Treatment Effects in IBS Trials Heather 10/20/03 03:30 PM FDA Orders Novartis To Pull Zelnorm Ads Heather 10/07/03 11:25 PM Step-down dosage of PPI drugs for hearburn Heather 09/30/03 01:26 PM Evaluation of drug treatment in irritable bowel syndrome Heather 09/30/03 12:52 PM Pain Relievers and Intestinal Disorders Heather 09/16/03 04:20 PM Hypersensitivity and hyperreactivity in IBS: opportunity for drug discovery Heather 07/18/03 12:39 PM Antidepressants in the Treatment of IBS and Other Functional GI Disorders Heather 07/18/03 12:20 PM Use of Antidepressants in the Treatment of IBS? Heather 07/14/03 03:58 PM Combined use of SSRIs and NSAIDs increases the risk of GI adverse effects Heather 07/14/03 03:15 PM

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