FDA Rejects New Drug for Irritable Bowel Syndrome
Last November, the FDA forced the IBS drug Lotronex to be taken off the market. Lotronex, which was made by Glaxo Wellcome, appeared to be a promising treatment for IBS when it was approved in February, 2000, but the FDA decided to remove it from the market after receiving complaints of serious gastrointestinal problems, including five deaths, possibly associated with the drug.
Novartis feels that the FDA may be taking a cautious approach to Zelnorm because of Lotronex, Pozarek says. Public Citizen's Health Research Group, a consumer advocacy organization, could be another factor. In March, the watchdog group filed a petition with the FDA claiming that Zelnorm increases a woman's risk for developing ovarian cysts. The drugmaker disagrees and says Public Citizen's concerns were based on incomplete information.
At a meeting last year, the FDA's own gastrointestinal drugs advisory committee said Zelnorm was effective and "did not voice any safety concerns," the agency's Jason Brodsky tells WebMD.
In addition, the FDA issued an "approvable" letter to Novartis in August, which stated that the drug could be approved, provided the company conducted one additional trial to confirm that the drug was safe and effective. Novartis conducted this trial and thought it had satisfied the FDA's concerns, Pozarek says.
"It is unusual" for the FDA not to follow the recommendation of its advisory committees, which consist of independent experts, Brodsky says, but he declined to offer further insight on why the FDA rejected Zelnorm.
Pozarek says Novartis has not decided if it will appeal the FDA's decision.