FDA Okays Plan to Allow Restricted Use of Tegaserod (Zelnorm)

ROCKVILLE, Md., July 27 -- Tegaserod (Zelnorm), the irritable bowel syndrome and constipation drug pulled from the market last spring, will make a limited return under an FDA plan that permits its use in certain symptomatic women younger than 55.
The FDA said today it will permit use of the drug under an investigational new drug (IND) protocol to treat IBS with predominant constipation and chronic idiopathic constipation in women in "critical need" whose physicians "decide the drug is medically necessary."
Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of tegaserod.
The announcement does not, however, signal a return to the aggressive direct-to-consumer "talking tummy" campaign that fueled $560 million in tegaserod sales in 2006.
Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, said the drug "will remain off the market for general use."
Tegaserod can only be prescribed for patients who meet "strict criteria and have no known or pre-existing heart problems," Dr. Galson said.
Last March 30, the FDA said that tegaserod's maker, Novartis, agreed to withdraw tegaserod after a meta-analysis revealed an apparent increase in ischemic events in those taking the drug.
Heart Risk Prompts FDA to Pull IBS Agent Tegaserod (Zelnorm)
The pooled analysis of data from 29 placebo-controlled trials identified 13 ischemic events among 11,614 patients treated with tegaserod compared with a single case among 7,013 placebo-treated patients. The rate of ischemic events was 0.11% in the tegaserod patients versus 0.01% in the placebo group, a difference that Novartis said was not statistically significant.
One of the 13 events was fatal versus no ischemic deaths in the placebo patients.
Tegaserod was the only FDA-approved treatment for IBS with predominant constipation, and when the FDA announced the withdrawal it said it recognized that the action would cause clinical management problems for patients who used the drug for that indication.

China halts production of Novartis drug

Fri Jun 8, 11:09 AM ET
China's drug watchdog on Friday ordered domestic companies to stop producing and selling Novartis AG's Zelnorm for irritable bowel syndrome and warned patients to stop taking it.
"The risks of Zelnorm outweigh the possible benefits for some patients based on analyses from home and abroad," China's State Food and Drug Administration said in a statement posted to agency's Web site.
The agency said China's National Center for Adverse Drug Reaction Monitoring has received 98 reports of adverse reactions concerning Zelnorm since it was introduced to the Chinese market in 2003. Most involved diarrhea and nausea, with one reported case of abnormally fast heartbeat and another of low blood pressure.
Two drug companies in southern city of Chongqing and one Beijing drug manufacturer were ordered to stop production of the drug, the agency said. A third company in Chongqing was told to halt plans to start producing it.
The official Xinhua News Agency said that hundreds of thousands of Chinese patients use the drug.
"We have announced this morning that we are complying with a request from the local authority to suspend the marketing and sales activity of (Zelnorm) in China," Novartis spokeswoman Corinne Hoff said.
"More than 85 percent of our sales were in the U.S," she said.
"I cannot give you the sales figures for China, but it's not significant," Hoff said.
Novartis agreed in March to stop selling Zelnorm in the United States, the name under which it was sold there, at the request of the Food and Drug Administration after it was linked to a higher chance of heart attack, stroke and worsening chest pain that can become a heart attack.

Swiss ask Novartis to withdraw drug

The Swiss pharmaceuticals regulator said Thursday it ordered the withdrawal of Novartis AG's Zelmac for irritable bowel syndrome, saying the risks of the treatment are greater than the benefit.
Swissmedic, the regulatory agency, said a new analysis of the data from clinical studies revealed an increased risk of cardiovascular issues, such as angina and heart attack, with the medicine when compared to a placebo.
Novartis agreed in March to stop selling Zelnorm in the United States, the name under which it was sold there, at the request of the Food and Drug Administration after it was linked to a higher chance of heart attack, stroke and worsening chest pain that can become a heart attack.
Novartis reacted to the Swissmedic decision with "surprise and disappointment," according to a statement.
The company said it would comply with the request, but is still convinced that Zelmac offers important benefits to patients. Novartis said Swissmedic had rejected a compromise to partially allow the restricted and controlled sale of the medicine.
Zelmac, or Tegaserod, has been licensed in Switzerland since the end of October 2001 for the treatment of irritable bowel syndrome, including stomach pain and constipation, in women.