Lawyers Seek FDA Zelnorm Documents through Freedom of Information Act

Philadelphia PA 2/20/2007 (PRLeap) — The law firm of Anapol Schwartz Weiss Cohan Feldman & Smalley has filed a request 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.

In its letter to the FDA Division of Freed of Information, the lawyers seek:
· Documents concerning epidemiology of Zelnorm and its side effects
· Correspondence with Novartis Pharmaceuticals Corporation concerning approval of Zelnorm
· Documents concerning epidemiology that led FDA to request Novartis Pharmaceuticals Corporation cease marketing of Zelnorm
· Correspondence with Novartis Pharmaceuticals Corporation concerning cessation of marketing of Zelnorm
· Hearing Transcripts related to or that formed the basis of approval of and subsequent request to remove Zelnorm from the market
· Safety and effectiveness data submitted to the Food and Drug Administration (FDA) for Zelnorm
· Study protocols and adverse reaction reports concerning Zelnorm
· Documents related to the testing of Zelnorm
· Documents about the marketing of Zelnorm

“We believe that the FDA documents contain information critical to the protection of the rights our clients who have taken Zelnorm and thereafter suffered a heart attack. Our clients want to know what the FDA was told about the dangers of Zelnorm and why this drug was not pulled from the market sooner,” said Tracy Finken, Esq., an attorney at the Philadelphia based Anapol firm, who is preparing to file Zelnorm lawsuits.

Zelnorm (tegaserod) is a GI drug that had been approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation. The FDA originally approved Zelnorm in July 2002 for the short-term treatment, four to six weeks, of women, only, with constipation-predominant irritable bowel syndrome (IBS). In August 2004, men and women under age 65 could also use the drug in the United States as Zelnorm was approved at that time by the Food and Drug Administration.

Zelnorm was not the only option available to patients with IBS. It is also not the first to be associated with heart problems. In 2000, digestive-system drugs Propulsid and Lotronex were also taken off the market. Propulsid was likewise found to cause heart problems.

Zelnorm was not immediately approved by the FDA. In 2001, the FDA said that Zelnorm was “not approvable” and requested more data regarding patient side effects. It was not until 2002 that Novartis gained approval of Zelnorm for the short-term treatment of irritable bowel syndrome in women.

The FDA was not alone in keeping Zelnorm off the market. Twice in 2005 the European Medicines Agency rejected Zelnorm for IBS. Even after the FDA allowed Zelnorm onto the market, stricter labels were later required. In both 2004 and 2005, the FDA required stricter labeling to warn of the risk of diarrhea and ischemic colitis. According to the FDA, several Zelnorm deaths were reported among patients with these conditions.

In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of tegaserod for treatment of a variety of gastrointestinal tract conditions. The data from all the studies were combined to assess the chance of side effects on the heart and blood vessels. In each study, patients were assigned at random to either Tegaserod or a sugar pill they thought was Tegaserod.

Attorney Finken, who reviewed the FDA announcement (P07-55) said that “the risk of heart attack was 10-times that of placebo. According the FDA analysis ‘the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment. Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.’”

Source: Anapol Schwartz, Weiss, Cohan, Feldman and Smalley, P.C. Contact: Anapol Schwartz, Tracy Finken, Esq., (215) 735-0773, 215-735-1130

About Anapol Schwartz P.C.
Since 1977 the http://www.anapolschwartz.com [Philadelphia law firm of Anapol Schwartz] has been of the nation's preeminent law firms known for landmark verdicts and settlements and for providing clients with the highest level of personalized legal services. Eleven of Anapol Schwartz's lawyers have received jury verdicts in excess of $1 million. The firm specializes in maintaining its tradition of excellence in personal injury, medical malpractice, pharmaceutical, toxic tort, class actions, construction site accidents, products liability, automobile litigation, security/investment fraud, and employment litigation.

Tracy Finken, Esquire
Tracy A. Finken, Esq. is an attorney at Anapol Schwartz who concentrates her practice on class actions, pharmaceutical liability, medical and other professional malpractice, products liability and other complex civil litigation.

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