Zelnorm Production Halted in China
June 14, 2007 14:30

Following the example of the United States, health regulators in China have issued an order to withdraw Novartis' irritable bowel syndrome drug Zelmac from the market.

The country's State Food and Drug Administration said it had made the decision because the risks of Zelnorm outweigh the possible benefits for some patients based on analyses from home and abroad. China's move comes in the wake of similar decisions taken in the USA and more recently in Switzerland where sales of the drug have been suspended amid fears of cardiovascular risk.

Zelnorm has been available in China since 2003 and the country's National Centre for Adverse Drug Reaction Monitoring has received 98 reports of adverse reactions, notably diarrhea and nausea. One case of tachycardia was reported, as were two concerning heart palpitations and one case of low blood pressure.

Source: http://www.pharmatimes.com/WorldNews/Articles/11038-china-zelnorm.aspx?src=PTArchive

Mother Demands Zelnorm: Will Take the Risk
May 1, 2007 09:48

http://www.myfoxwghp.com/myfox/pages/News/Detail?contentId=3038242&version=3&locale=EN-US&layoutCode=TSTY&pageId=3.2.1

What's a mother to do when Zelnorm is recalled? The North Carolina woman says that Zelnorm is the only drug that has helped her 22-year-old son with his rare gastrointestinal problems or weight loss and vomiting.

The mother called Novartis to ask for a special prescription waiver but they said it would take months to pass through the FDA bureaucracy and the mother feels her son cannot wait.

Alternative Drug to Zelnorm
April 30, 2007 09:45

Alternative Drug to Zelnorm - http://www.pharmalive.com/News/index.cfm?articleid=435237&categoryid=10

Kristalose is a prescription laxative product that treats acute and chronic constipation. Constipation is a common disorder affecting approximately 20 percent of the U.S. population.

Kristalose may be an effective alternative for some patients previously treated with Zelnorm. Marketing of Zelnorm was suspended recently after new data showed that a statistically significant number of cardiovascular problems occurred in patients taking Zelnorm since it was approved in 2004.

Kristalose Oral Solution is a proprietary prescription laxative and the brand name for a unique crystalline form of lactulose. Available in pre-dosed packets, the drug dissolves quickly in four ounces of water, offering patients a virtually tasteless and grit-free alternative to other liquid lactulose treatments. Initial dosing may produce flatulence and intestinal cramps, which usually go away.

Lawyers Seek FDA Zelnorm Documents through Freedom of Information Act
April 20, 2007 06:13

The law firm of Anapol Schwartz has filed a request (FOIA request to FDA.pdf) with the Food and Drug Administration (FDA) under the Freedom of Information Act (FOIA, 5. U.S.C. 552) seeking documents and records as they pertain to the Novartis Pharmaceuticals Corporation’s drug Zelnorm (tegaserod maleate). In particular the request seeks those documents that lead the FDA to request that Novartis cease marketing Zelnorm.

FDA Announces Discontinued Marketing of IBS-Constipation Drug Zelnorm
April 11, 2007 12:12

http://www.medicalnewstoday.com reports that The Food and Drug Administration (FDA) has requested that the New Jersey pharmaceutical company, Novartis, voluntarily discontinue marketing Zelnorm. Recent findings discovered an increased risk of serious heart... (Read Article)