Two of the five Zelnorm patients had known gallstone disease before taking the drug.
Now it is up to the company's U.S. sales force to make Zelnorm deliver on its promise.
Lotronex was for preventing diarrhea, not constipation, but the doctors still may be shy about prescribing Zelnorm.
Approval for Zelnorm, a treatment for painful constipation known as irritable bowel syndrome, was delayed on safety concerns.
Novartis had high hopes for Zelnorm, a new drug it put up for FDA approval two years ago.
Graves has compared Zelnorm prescriptions to other drugs where drugmakers had to convince doctors to treat heretofore unrecognized diseases.
Carter won't mention Zelnorm by name and Novartis is funding the relatively inexpensive campaign through the nonprofit Society for Women's Health Research.
Zelnorm "is a loss, but we will overcome it, " says Vasella, who hopes to get the drug back on the market eventually.
But Zelnorm is the only treatment approved for IBS marked by constipation.
Eli Lilly's Zyprexa, Glaxo's Zantac and Novartis' Zelnorm are all GPCR-related drugs.
The long saga of Novartis' Zelnorm underscores the frustrations of drug firms.
Big, headline-grabbing drug withdrawals that affect millions of patients, like those of Baycol, Vioxx, and Zelnorm, could become a thing of the past.
But Vasella is considerably less kind to consumer interest groups like Sidney Wolfe's Public Citizen, which jumped on Zelnorm as a potentially dangerous drug.
Zelnorm, a Novartis drug for painful bowel symptoms, was pulled from the market because of another meta-analysis that showed an increased risk of heart attacks.
On Friday, the Food and Drug Administration asked Novartis to pull its heavily advertised constipation drug, Zelnorm, after finding a potential link to heart problems.
Zelnorm's approval was delayed because, although the drug seemed to work, regulators noticed a few cases where patients reported gallbladder problems, some of which required surgery.
"This study provides further evidence that Zelnorm is a safe and effective treatment for IBS patients, who suffer with abdominal pain, bloating and constipation, " said John F.
But in order to make Zelnorm a blockbuster, Novartis needs to get patients to go to the doctor and ask for help for their irritable bowel disorder.
In the past three months the FDA has slapped cautionary labels on sleeping pills and yanked Novartis' constipation drug Zelnorm after that company's analysis showed heart problems.
In June, the FDA had sent the company a "not approvable" letter regarding Zelnorm, saying that further studies would need to be conducted before it could be approved.
The message: If a woman has abdominal pain, bloating and constipation ("the ABC's of IBS"), she should go see a doctor because a new treatment (Zelnorm) is available.
Kurt Graves , Novartis' general manager of U.S. commercial operations, says he expects the campaign to help get women into doctors' offices--and that will help drive Zelnorm sales.
Zelnorm, formerly known as Zelmac, treats irritable bowel disorder (IBS)--a combination of constipation, stomach pain and other severe symptoms that affects up to 15% of the population, mostly women.
Eli Lilly (nyse: LLY - news - people )'s Zyprexa, Glaxo's Zantac and Novartis (nyse: NVS - news - people )' Zelnorm are all GPCR-related drugs.
But Novartis was able to get the drug approved by carefully going back over the data with the FDA and demonstrating that the gallbladder surgeries did not appear to be caused by Zelnorm.
In the past two days, Novartis (nyse: NVS - news - people) has quietly released new information about both medications, set a new timetable for getting Xolair approved and published new data on Zelnorm.
In the past three months the FDA has slapped cautionary labels on sleeping pills and yanked Novartis (nyse: NVS - news - people )' constipation drug Zelnorm after that company's analysis showed heart problems.
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