Advisors Recommend Zelnorm for Constipation
But Expert Panel Would Limit Drug to Women Under Age 65
"The role of [Zelnorm] cannot be ruled out," says Gary Della'Zanna, DO, a safety reviewer with FDA's division of drug risk evaluation.
Doctors have written more than 2 million Zelnorm prescriptions since its initial approval. But the cases prompted the FDA to send out millions of letters alerting of the risks of ischemic colitis and a side effect of severe diarrhea in some patients.
In a 12-week study of 1,265 patients submitted by Novartis, 43% of those taking 6 milligrams of Zelnorm per day experienced an improvement in constipation vs. 31% who experienced similar improvement with placebo. Another study showed similar responses.
Experts expressed concern, however, that both men and adults aged 65 and over were underrepresented in the studies.
Panelists were unanimous in rejecting a recommendation that Novartis had shown the drug to be safe or effective in elderly persons. They voted 8 to 5 to reject the drug's safety for men, citing insufficient data.
"This is not what we expected," one Novartis official said following the vote.
Bo Joelsson, MD, head of gastroenterology for Novartis, says that despite the panel's recommended restrictions, the company is still optimistic. "This is not really an elderly problem. This is a problem in all age groups. There's still a lot of patients that need this drug," he tells WebMD.
Advisors Recommend Zelnorm for Constipation
But Expert Panel Would Limit Drug to Women Under Age 65
Safety Concerns continued...
"The role of [Zelnorm] cannot be ruled out," says Gary Della'Zanna, DO, a safety reviewer with FDA's division of drug risk evaluation.
Doctors have written more than 2 million Zelnorm prescriptions since its initial approval. But the cases prompted the FDA to send out millions of letters alerting of the risks of ischemic colitis and a side effect of severe diarrhea in some patients.
In a 12-week study of 1,265 patients submitted by Novartis, 43% of those taking 6 milligrams of Zelnorm per day experienced an improvement in constipation vs. 31% who experienced similar improvement with placebo. Another study showed similar responses.
Men and Elderly Understudied
Experts expressed concern, however, that both men and adults aged 65 and over were underrepresented in the studies.
Panelists were unanimous in rejecting a recommendation that Novartis had shown the drug to be safe or effective in elderly persons. They voted 8 to 5 to reject the drug's safety for men, citing insufficient data.
"This is not what we expected," one Novartis official said following the vote.
Bo Joelsson, MD, head of gastroenterology for Novartis, says that despite the panel's recommended restrictions, the company is still optimistic. "This is not really an elderly problem. This is a problem in all age groups. There's still a lot of patients that need this drug," he tells WebMD.