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29-10-2003 à 08:01:00
SOLVAY presses ahead with cilansetron registrations following favorable phase III clinical findings
SOLVAY announces today that headline results from the first two large placebo-controlled phase III efficacy studies show convincing evidence for the patient benefits of cilansetron, a novel drug developed by the Group's PHARMACEUTICALS subsidiaries for the treatment of Irritable Bowel Syndrome with predominantly diarrhea (IBS-D). In view of favorable clinical findings, SOLVAY will expedite compilation of registration dossiers for major territories, beginning with submissions in Europe and the United States in the first quarter of 2004. Registration submissions in other territories will follow.
SOLVAY is running a full phase III clinical program with cilansetron, a 5HT3 antagonist for the treatment of Irritable Bowel Syndrome with predominantly diarrhea. Together with our preferred-provider QUINTILES, more than 4,000 patients have been entered into phase III clinical studies. Cilansetron was created by SOLVAY's own in-house drug-discovery efforts. In two Phase II placebo controlled clinical studies and two Phase III placebo controlled clinical studies conducted in the US, Europe and other countries, cilansetron has shown clinical benefits in both males and females.
IBS is a frequently encountered troublesome condition, characterized by abdominal pain, bloating and altered bowel habits. IBS has a significantly negative impact on quality-of-life for the large populations of men and women suffering from it.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 30,000 people in 50 countries and had consolidated sales in 2002 of EUR 7.9 billion, generated by four sectors of activity: Pharmaceuticals, Chemicals, Plastics and Processing. The Group's pharmaceuticals subsidiaries employ 7500 people and have a good research and development pipeline, with several projects alongside cilansetron currently in phase III/II testing; bifeprunox for schizophrenia (together with Lundbeck), tedisamil for atrial fibrillation and cetrorelix for endometriosis, myoma and benign prostatic hypertrophy just to mention a few. SOLVAY is listed in the Euronext 100 index of top European companies. For further information please consult: www.solvay.com
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Pharmacological Options
Pharmacological options aim to control irritable bowel syndrome symptoms, bowel alterations and abdominal pain with drugs mainly targeted to the gastrointestinal tract or the central nervous system.
The majority of the available drugs have been tested and are used in the management of individual symptoms, and not to control the whole range of symptoms inherent in the complex irritable bowel syndrome. Loperamide has been shown to be effective in the control of functional diarrhoea, and osmotic and contact laxatives and polyethylene solution in the control of functional constipation. These agents, however, have no effect on, or may even aggravate, other symptoms, such as pain and bloating.[49,50] In addition, their use is indicated only as a symptomatic, on-demand treatment in selected patients, as their effect may be unpredictable or even undesirable in the majority of irritable bowel syndrome patients who present with an alternating bowel pattern.
The smooth muscle relaxants, cimetropium bromide, pinaverium bromide, octilonium bromide, trimebutine and mebeverine, have been shown to be more effective than placebo in three meta-analyses.[41,51,52] On average, the global symptom improvement with myorelaxants exceeded that of placebo by 22%. However, the benefit was due essentially to their effect on abdominal pain and abdominal distension (18% and 14% over placebo, respectively) with no effect on bowel alterations.[52]
Besides being of limited value, the therapeutic benefit of myorelaxants was demonstrated in clinical trials that were hampered by methodological problems. The trials were performed in non-homogeneous groups of patients who presented with different types of functional bowel alterations and were not selected on the basis of standardized irritable bowel syndrome symptom-based criteria.
Psychotropic drugs, mainly low-dosage tricyclic antidepressants, have been used in non-constipated irritable bowel syndrome patients with abdominal pain as the chief complaint. A meta-analysis based on a few uncontrolled trials indicated that they were useful in about one-third of patients.[53] However, their efficacy has not been assessed in randomized, double-blind, placebo-controlled trials.*
*After submission of this article, a randomised, double-blind, placebo-controlled trial has been published showing that the tricyclic antidepressant desipramine may be effective in clinical subgroups of patients with functional bowel disorders (Drossman DA, Toner BB, Whitehead WE, et al. Gastroenterology 2003; 125: 19-31.
http://www.medscape.com/viewarticle/463164_5
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UEGW: Renzapride Improves Symptoms in Constipation-Predominant Irritable Bowel Syndrome
By Adrian Burton
MADRID, SPAIN -- November 4, 2003 -- Renzapride, a new 5-HT4 agonist/5-HT3 antagonist, relieves the symptoms of constipation-predominant irritable bowel syndrome (C-IBS), increasing bowel movement frequency and softening stools.
Dr. Nicholas Meyers, Development Manager for Alizyme Therapeutics Ltd, Cambridgeshire, United Kingdom, reported the results here November 3rd at the 11th United European Gastroenterology Week.
Irritable bowel syndrome is a common disease, the symptoms of which may include constipation, diarrhoea or both. "There really are no suitable treatments for irritable bowel syndrome [in Europe]," explained Dr. Meyers. "By and large, the sort of treatments people can buy over the counter such as peppermint oil don't really work. So we need more active drugs."
In this large, placebo controlled, double blind Phase IIb trial that enrolled 510 patients with C-IBS, 125 received 1 mg of renzapride, 125 other patients received 2 mg of the drug, and 135 received 4 mg of renzapride, while 125 received placebo. Treatment was dosed every day for 12 weeks.
Patients kept diaries to record their perceived response to treatment in terms of pain or discomfort relief, and recorded their frequency of bowel movements and the consistency of their stools.
The 4-mg/day dose significantly increased the frequency of bowel movements from a mean of 0.9 to 1.7 in Week 1, decreasing after that time, but remaining significant during Weeks 1 through 4 (P < .0001) and through to the end of the study (P < .0046). The same dose also improved stool softness (from a baseline of 0.2 on an arbitrary softness scale to over 0.5 in Weeks 1 through 4 (P < .0048), and to just under 0.5 during weeks 5-12 (P < .016).
When analysed alone, the female population showed slightly better results.
Adverse events at the effective 4-mg/day dose were diarrhoea in 25.2% of patients and headache in 17.8%. The rate of serious adverse events was 1.6% for all patients taking renzapride compared to 2.4% for those taking placebo.
"We hope to be reporting the effects of renzapride in mixed-symptom patients in May [2004]," explained Dr. Meyers. "But the main message here is that [renzapride] 4 mg/day seems to work very well for C-IBS patients."
[Study title: Efficacy and Safety of Renzapride in Patients With Constipation-Predominant IBS: A Phase IIb Study in the UK Primary Healthcare Setting. Abstract Mon-G-161]
http://www.docguide.com/news/content.nsf/news/8525697700573E1885256DD4004D8FD7
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Zelnorm Warning Issued by FDA
On April 28, 2004, the Food and Drug Administration (FDA) announced the addition of serious new risk information to the health professional labeling for Zelnorm. The specific revisions include:
a new warning about the serious consequences of diarrhea associated with the medication
a new precaution about ischemic colitis and other forms of intestinal ischemia (reduced blood flow to the intestines)
changes to the adverse reactions section describing post-marketing reports
new information in the "Information for the Patient" leaflet
The new warning states: "Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea."
"The FDA currently has 21 reports of diarrhea so severe that it caused such complications as low blood pressure and fainting. Sixteen patients required hospitalization," said the FDA's Dr. Robert Justice.
The new precaution on ischemic colitis states: "Ischemic colitis, and other forms of intestinal ischemia, have been reported in patients receiving Zelnorm during marketed use of the drug. A causal relationship between Zelnorm use and these events has not been established. Placebo-controlled clinical trials of 7,000 patients for 3-month duration showed no cases of these events, and would suggest the rate of these events is low. Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis."
"Since Zelnorm went on sale in 2002, the FDA has received 20 reports of ischemic colitis, plus three reports of a similar intestinal problem," Justice said. "Fourteen patients were hospitalized. Four died, although they had numerous other serious medical conditions."
Consumer watchdog Sidney Wolfe said Zelnorm is too dangerous to stay on the market and only slightly more effective than a placebo. He had urged the FDA not to approve the drug in the first place.
"If a drug is actually more dangerous than a placebo and not much more effective, it is a very bad trade-off," Wolfe, head of Public Citizen's Health Research Group, said in an interview.
Under the post marketing experience heading in the adverse reactions section, the labeling now states: "Voluntary reports of adverse events occurring with the use of Zelnorm include the following: ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope, suspected sphincter of Oddi spasm, bile duct stone, and cholecystitis with elevated transaminases. Because these cases are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. No causal relationship between these events and Zelnorm use has been established. Hypokalemia secondary to diarrhea has also been reported."
The new patient information advises patients who get new or increased stomach pain or blood in their stools to stop taking Zelnorm right away and to immediately contact their doctor to determine if they may have a serious problem. In addition, the new labeling advises patients to stop taking Zelnorm and to call a doctor right away if they experience diarrhea that leads to lightheadedness, dizziness or fainting. In conjunction with today's FDA announcement, the manufacturer of Zelnorm, Novartis Pharmaceuticals Corporation of East Hanover, N.J., has issued a letter to health professionals to highlight the labeling changes.
http://www.helpforibs.com/footer/zelnorm.asp#warning
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Glaxo seeks fewer barriers to Lotronex
By Lisa Richwine
ROCKVILLE, Md., May 5 (Reuters) - Limits put in place to minimize potentially deadly risks from an irritable bowel drug may be discouraging too many seriously ill patients from using it, maker GlaxoSmithKline Plc <GSK.L> said on Wednesday.
Glaxo pulled Lotronex off the market in November 2000, eight months after its debut, because of dozens of reports of users suffering severe constipation or ischemic colitis, inflammation of the large bowel caused by reduced blood flow. At least five patients died from those complications.
The medicine was re-introduced in November 2002, with restrictions, in order to provide access to patients with severe forms of the disease and few options.
Doctors are encouraged to report side effects and sign a form saying they have told a patient about risks. Patients also are asked to sign a consent form.
The program may have frightened away some patients and burdened doctors, said Craig Metz, GlaxoSmithKline vice president for U.S. regulatory affairs.
"We are going to look for ways to make this less onerous" while maintaining safeguards, Metz told a Food and Drug Administration advisory committee.
About 10,000 patients, a far lower number than expected, received at least one Lotronex prescription from November 2002 through December 2003, Metz said. Only between 10 percent and 20 percent of patients got refills.
At least 111,000 patients may have severe cases of irritable bowel syndrome and could benefit from the drug, GSK officials said.
Some FDA panel members said the program was working by discouraging many patients from using the medicine.
"That is what the point is," said Robyn Shapiro, professor of bioethics at the Medical College of Wisconsin.
The FDA believes the risk reduction program has been successful but will work with the manufacturer to identify overly restrictive barriers to drug access, said Dr. Robert Justice, head of the FDA's gastrointestinal drugs division.
No drug-related deaths were reported between November 2002 and February 2004, GlaxoSmithKline said. Eight cases of ischemic colitis, a potentially fatal reduction of blood flow to the colon, were recorded, as well as 5 cases of severe complications from constipation.
Consumer watchdog Dr. Sidney Wolfe said the restrictions had failed to adequately protect patients. He said the drug should once again be withdrawn, and a tightly controlled research program set up for seriously ill patients, he said.
GlaxoSmithKline has said it does not expect Lotronex to significantly impact the giant London-based drug maker's finances.
Irritable bowel syndrome, or IBS, causes alternating bouts of constipation and diarrhea as well as abdominal pain and sometimes incontinence. Severe cases can be debilitating.
Lotronex is the only prescription drug approved for treating women with IBS whose main symptom is diarrhea.
Copyright 2004, Reuters News Service
http://www.forbes.com/business/healthcare/newswire/2004/05/05/rtr1360714.html
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Irritable bowel syndrome helped by Paroxetine, a drug for depression
08 May 2004
Paroxetine, a drug commonly used to treat depression, can improve symptoms in people with irritable bowel syndrome (IBS), according to a study in the May issue of the American Journal of Gastroenterology. In a randomized double-blind, placebo-controlled study, researchers at the University of Pittsburgh School of Medicine found that the drug relieved some symptoms of IBS and improved the well-being of people with IBS.
"This study points out the benefits of this drug as a potential new and improved treatment for IBS, a disease that is very difficult for physicians to manage," said George Arnold, M.D., F.A.C.P., clinical professor of medicine at the University of Pittsburgh School of Medicine and principal investigator in the study.
IBS is a chronic gastrointestinal disorder that affects 14-24 percent of women and 5-19 percent of men in western populations and is characterized by abdominal pain, altered bowel habits and abdominal bloating. It generally has been treated with high-fiber diet, drugs or both.
The study found that the percentage of participants experiencing an improvement in overall well-being was significantly greater (63.3 percent) in the paroxetine group than the placebo group (26.3 percent). The percentage of participants experiencing an improvement in bowel movements was significantly greater in the paroxetine recipients (58.6 percent) than the placebo recipients (32.4 percent). There was a significant improvement in food avoidance and work function for those on paroxetine. There was no significant improvement in abdominal pain or bloating between the paroxetine and placebo groups.
"This study showed that in absence of depression, paroxetine helped irritable bowel syndrome," said Dr. Arnold. "This is a medicine that has been in use for some years and is safe with no long term side effects, which is a problem with current medications for IBS."
The effectiveness of paroxetine, a selective serotonin reuptake inhibitor (SSRI), has been reported in case reports but not in controlled studies. SSRIs are considered first line treatments in psychiatric illnesses such as major depression and generalized anxiety disorder, which are found in 50 to 90 percent of patients with IBS, according to Dr. Arnold, who is a gastroenterologist at the University of Pittsburgh Medical Center's (UPMC) Shadyside Hospital.
The two-part clinical study enrolled a total of 110 participants with IBS. Group one consisted of 98 participants who at enrollment were consuming a low-fiber or average-fiber diet, who were then put on a high-fiber diet. In this group, 26 percent reported an overall improvement in well-being. Abdominal pain and bloating decreased in 22 percent and 26 percent of participants respectively.
Group two consisted of 12 participants who at enrollment were already consuming a high-fiber diet plus the 69 participants from group one who reported an inadequate response to the high-fiber diet. Group two participants continued to consume their high-fiber diet throughout the study and were randomized to receive a 12-week course of either paroxetine or a placebo.
All participants began with a dosage of paroxetine of 10 mg/day. Participants who experienced improvement in their condition were instructed to continue at the same dosage while those who experienced no improvements were instructed to increase their dosage.
Because SSRIs have a well-recognized effect on depression, the researchers also performed a separate analysis of participants and showed that the improvement in well-being held true for non-depressed patients taking paroxetine.
Also participating in the study were Gary Tabas, M.D., Mary Beaves, R.N., Jiping Wang, M.D., Paul Friday, Ph.D. and Houssam Mardini, M.D.
The study was funded by the Competitive Research Fund of the Shadyside Hospital Foundation of Pittsburgh.
ADDITIONAL CONTACT:
Jocelyn Uhl
PHONE: 412-647-3555
FAX: 412-624-3184
E-MAIL:
UhlJH@upmc.edu
Contact: Frank Raczkiewicz
RaczkiewiczFA@upmc.edu
412-647-3555
University of Pittsburgh Medical Center
http://www.medicalnewstoday.com/index.php?newsid=8065
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Researchers at The University of Nottingham, England have picked up almost £1 million in funding for a number of studies into a painful and distressing bowel condition that will affect up to one in 10 of the population at some time or another.
The team in the Division of Gastroenterology at the University, led by Professor Robin Spiller, are looking at various aspects of Irritable Bowel Syndrome (IBS) in a bid to increase our understanding of the mechanisms that underpin the condition and to develop new treatments for patients.
They have received £434,563 in funding from the drug company GlaxoSmithKline for a study examining evidence for inflammation of the gut in IBS patients. It is believed that some IBS patients may have a genetic predisposition to this kind of inflammation, which is usually associated with other bowel disorders such as Crohn's disease and ulcerative colitis. Often these patients have to undergo many tests that turn out to be unnecessary before being correctly diagnosed with IBS.
Another aspect of the study is examining why as many as one in 10 people who suffer from severe Campylobacter food poisoning may go on to develop IBS. The study will be comparing people who have had a Campylobacter infection and developed IBS with those who have made a complete recovery to get a clearer idea of why some patients are at a greater risk.
Further research into inflammation in the gut in IBS may lead to new methods of identifying patients who would respond well to drugs not traditionally used for the treatment of bowel conditions but which are successfully used in the treatment of asthma.
The researchers have also received £172,914 from NovartisPharma and £360,000 from the Biotechnology and Biological Sciences Research Council to look at the role of serotonin in IBS. Serotonin is a ubiquitous signalling molecule used throughout the brain and gut to transmit impulses. The over-production of serotonin can cause vomiting and diarrhoea and part of the study is looking at whether serotonin levels can be altered by introducing different molecules into the system.
The researchers are seeking patients with IBS to take part in the study and anyone interested should contact Marguerite Richards on 0115 924 9924 ext 36804 or ext 44970 or by e-mail at marguerite.richards@nottingham.ac.uk
http://www.news-medical.net/view_article.asp?id=1439
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Neuroendocrinol Lett. 2004 Feb-Apr;25(1-2):31-9.
Clinical endocannabinoid deficiency (CECD): can this concept explain therapeutic benefits of cannabis in migraine, fibromyalgia, irritable bowel syndrome and other treatment-resistant conditions?
Russo EB.
GW Pharmaceuticals, 2235 Wylie Avenue, Missoula, MT 59802, USA. erusso@montanadsl.net
OBJECTIVES: This study examines the concept of clinical endocannabinoid deficiency (CECD), and the prospect that it could underlie the pathophysiology of migraine, fibromyalgia, irritable bowel syndrome, and other functional conditions alleviated by clinical cannabis. METHODS: Available literature was reviewed, and literature searches pursued via the National Library of Medicine database and other resources. RESULTS: Migraine has numerous relationships to endocannabinoid function. Anandamide (AEA) potentiates 5-HT1A and inhibits 5-HT2A receptors supporting therapeutic efficacy in acute and preventive migraine treatment. Cannabinoids also demonstrate dopamine-blocking and anti-inflammatory effects. AEA is tonically active in the periaqueductal gray matter, a migraine generator. THC modulates glutamatergic neurotransmission via NMDA receptors. Fibromyalgia is now conceived as a central sensitization state with secondary hyperalgesia. Cannabinoids have similarly demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms that promote pain in headache, fibromyalgia, IBS and related disorders. The past and potential clinical utility of cannabis-based medicines in their treatment is discussed, as are further suggestions for experimental investigation of CECD via CSF examination and neuro-imaging. CONCLUSION: Migraine, fibromyalgia, IBS and related conditions display common clinical, biochemical and pathophysiological patterns that suggest an underlying clinical endocannabinoid deficiency that may be suitably treated with cannabinoid medicines.
PMID: 15159679 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15159679
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By Greg Arnold, June 3, 2004, Abstracted from "The Relationship among Previous Antimicrobial Use, Antimicrobial Resistance, and Treatment Outcomes for Helicobacter pylori Infections" in The Annals of Internal
Medicine 2003, Volume 139, pp. 463-469
The use of antibiotics has resulted in an "arms race" between man and Nature. With Nature adapting to antibiotics by mutating and becoming antibiotic-resistant, formation of "superbugs" is now commonplace, so much so that many experts are even discouraging the use of antibacterial soaps for they are ineffective at preventing bacterial infections(2) and may contribute to the "superbug" explosion.
A chronic bacterial infection in people is Helicobacter pylori, the cause of peptic ulcers. It is estimated that one in ten Americans develop a peptic ulcer at some time in his or her life. H. pylori weakens the protective mucous coating of the stomach and duodenum, which allows acid to get through to the sensitive lining beneath, irritating the lining and causing the ulcer. H. pylori is able to survive in stomach acid because it secretes enzymes that neutralize the acid. This mechanism allows H. pylori to make its way to the "safe" area--the protective mucous lining. Once there, the bacterium's spiral shape helps it burrow through the lining.(1)
Now it appears that antibiotic use makes it harder to get rid of peptic ulcers, according to a new study in the Annals of Internal Medicine. Not knowing the relationship between previous antimicrobial treatments and infection with drug-resistant H. Pylori, researchers sought to determine whether previous antibiotic use causes antibiotic
resistance of H. Pylori.
Conducting a retrospective cohort analysis of adults recruited sequentially from a clinical practice, researchers studied 125 adults with an H. Pylori infection in a referral hospital in Anchorage, Alaska. They reviewed antibiotic use in the 10 years before H. Pylori infections occurred and found that 120 of the 125 patients (96%) had
H. Pylori that was resistant to two of the more common antibiotics, clarithromycin and metronidazole.
The researchers concluded, "previous use of macrolides and
metronidazole is associated with H. Pylori resistant to these antimicrobial agents. Clarithromycin resistance is associated with a greater risk for failure with larithromycin-based treatments."
Instead of using antibiotics, a much more viable option for peptic ulcer sufferers is through probiotic supplementation, recently reviewed to be effective as an adjunctive treatment for H. Pylori infection.(3)
References:
1 National Digestive Diseases Information Clearninghouse (NDDIC)
Website: "H. Pylori and Peptic Ulcer"
<http://digestive.niddk.nih.gov/ddiseases/pubs/hpylori/>
2 Larson EL. Effect of antibacterial home cleaning and handwashing
products on infectious disease symptoms: a randomized, double-blind
trial. Annals of Internal Medicine 2004; 140(5): 321-9
3 Hamilton-Miller JM. The role of probiotics in the treatment and
prevention of Helicobacter pylori infection.
Internationals Journal
of Antimicrobial Agents 2003; 22(4): 360-366
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New Risk Information on Zelnorm for IBS for Women
11 Jul 2004
New risk information will now appear in the labeling for the drug Zelnorm, or tegaserod maleate. This medication is used for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.
The new labeling will contain a warning about the serious consequences of diarrhea in these patients, including hypovolemia, hypotension and syncope. The labeling also warns that patients on Zelnorm who develop hypotension or syncope should stop taking the drug. And patients who have or frequently experience diarrhea should not be started on Zelnorm.
The labeling will also contain a new precaution on ischemic colitis in patients receiving Zelnorm. Although a causal relationship has not been established, the drug should be discontinued immediately if the patient develops symptoms of ischemic colitis. These include rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.
The new information will also be incorporated in a revised leaflet for patients.
Additional Information:
All about Zelnorm for IBS: http://www.helpforibs.com/footer/zelnorm.asp
MedWatch Safety Alerts – Zelnorm (tegaserod maleate)
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#zelnorm
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