Briefs

Novartis Suspends Zelnorm® Sales After FDA Request

EAST HANOVER, N.J. — In April, Novartis complied with a request from the Food and Drug Administration (FDA) to suspend U.S. marketing and sales of Zelnorm® (tegaserod maleate), a treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation.

This action was taken after Novartis notified the FDA about a retrospective analysis of data from more than 18,000 patients in the clinical trial database. This was the result of an ongoing review involving a number of health authorities including the FDA. The review revealed a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking Zelnorm compared to those taking placebo.

Events occurred in 13 out of 11,614 patients treated with Zelnorm (0.11 percent), compared to one case in 7,031 placebo-treated patients (0.01 percent). All patients affected had pre-existing cardiovascular disease and/or cardiovascular (CV) risk factors. The rate of cardiovascular ischemic events seen in Zelnorm-treated patients in controlled trials corresponds approximately with the expected rates for such events in the general population.

Novartis and the FDA are discussing the best way to continue to make Zelnorm available to appropriate patients.

Source: Novartis Pharmaceuticals Corporation

CBSPD to Offer Credential for Endoscope Reprocessing Staff

ALPHA, N.J. -- The board of directors of The Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) announced a new credential for assessing competency of those individuals processing flexible GI endoscopes and bronchoscopes.

The board identified that a credential was needed due to the increasing frequency of use and sophistication of these devices.

To validate the knowledge and skills needed for competent performance in this practice setting, a job analysis survey (role delineation) was developed by subject matter experts in March 2007 and then evaluated by a peer review group. This survey will be posted on the CBSPD webpage beginning on May 22, 2007, for a three-week period of participation. (The end date will be June 12, 2007). To access the survey, visit the CBSPD Web page at www.sterileprocessing.org and click on the link for the “Flexible Scope Job Analysis Survey”.

Anyone who is currently responsible for processing flexible GI endoscopes and bronchoscopes is encouraged to access and participate in this survey. Widespread participation will enhance the content of the job analysis and ensure that it is comprehensive and representative of endoscopy practices nationally. The resulting data will become the blueprint for the flexible endoscope processing certification examination. The inaugural exam is proposed for November 2007.

By offering this credential, the CBSPD will be the only sterile processing certification board accredited by the National Commission for Certifying Agencies. The GI Endoscope certification examination will join the technician, supervisor, manager, surgical instrument processor and ambulatory surgery sterile processing technician certification examinations.

Source: CBSPD

Small Magnets Cause GI Injuries in Children

WASHINGTON —As the number of toys with magnets increases, so too does the number of related serious injuries to children. The U.S. Consumer Product Safety Commission (CPSC) is aware of hundreds of complaints that magnets have fallen out of various toys and at least 33 cases in which children swallowed loose magnets and required emergency surgery. In addition, a 20-month-old boy from Seattle died.

Of the 33 cases, the children ranged in age from 10 months to 11 years, the majority were older than three, and male. All of the injuries led to hospital stays, which ranged from three to 19 days. In nearly all cases reviewed by CPSC, children had suffered intestinal perforations.

In addition to the intestinal injuries from swallowing loose magnets, the CPSC is aware of one case of intestinal perforation after a child swallowed magnetic jewelry that was being worn on the child’s tongue, two cases of intestinal perforations after children swallowed complete components of building sets containing magnets, one aspiration of a loose magnet, and one perforation of the nasal wall from nose jewelry.

If two or more magnets, two or more magnet components, or a magnet and another metal object are swallowed separately, they can attract to one another through intestinal walls. Parents and physicians may think that the materials will pass through the child. But this is often not the case. The magnets become trapped in the body and can twist or pinch the intestine, causing holes, blockage and infection in the intestine, or blood poisoning.

To help prevent serious magnet ingestion injuries the CPSC recommends:

• Look for non-specific abdominal symptoms: abdominal pains, nausea, vomiting and diarrhea.
• Note that objects in X-rays may appear as a single object that could actually be multiple magnetic pieces separated by trapped intestinal walls.
• Keep small magnets and small pieces containing magnets away from young children who might mistakenly or intentionally swallow them.

Source: U.S. Consumer Product Safety Commission

New Study Links H. Pylori to Asthma Prevention

The stomach bacterium Helicobacter pylori, which causes stomach cancer and peptic ulcers, may not be all bad. According to a new study, it may help protect children from asthma.

The study, based on an analysis of a health survey of 7,663 adults, showed that a virulent strain of H. pylori was especially associated with being asthma-free before the age of 15. People who carry the strain were 40 percent less likely to have had asthma at an early age than those who didn’t carry the strain. The study also found that the microbe was associated with protection against ragweed and other allergies due to pollens and molds particularly among younger adults. The study was published in the April 23, 2007, issue of Archives of Internal Medicine.

“These properties point toward a much more complex view of the organism — not just as ulcer-pathogen or cancer-pathogen, but as an organism that has its costs and benefits to us,” says Martin J. Blaser, MD, the Frederick H. King professor of internal medicine, chairman of the department of medicine, and professor of microbiology at NYU School of Medicine, who has been studying H. pylori for more than 20 years. “The relative costs and benefits clearly differ among individuals.”

Blaser’s previous studies have confirmed the bacterium’s link to stomach cancer and elucidated genes associated with its virulence, particularly a gene called cagA. In recent years, he began to suspect that the organism may play a role in human health as well as disease, consistent with the hygiene hypothesis, suggesting that exposure to infections in early childhood prevents the development of allergies and asthma.

Blaser has proposed that H. pylori may protect against diseases such as gastroesophageal reflux disease (GERD) and adenocarcinoma of the esophagus. These conditions have become more common in developed countries as H. pylori has become far less common due to improved sanitation and widespread use of antibiotics, and the incidence of peptic ulcers and gastric cancer has declined in developed countries.

Today, less than 10 percent of children carry the organism in industrialized countries, while 90 percent of children are infected usually by age five in developing countries. “This bacterium has been the dominant organism in our stomach for tens of thousands of years, and it can’t disappear from us without consequences,” says Blaser. He says that a substantial body of work now shows that H. pylori helps protect against GERD and the conditions it leads to in the esophagus.

If the relationship between H. pylori and asthma is confirmed in other studies, then it raises the question about whether “we should be trying to eliminate Helicobacter from children,” says Blaser.

Source: New York University Medical Center

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