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Swiss Ask Novartis to Withdraw Drug

Posted on: Thursday, 31 May 2007, 12:00 CDT

ZURICH, Switzerland - 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.

Novartis shares slipped 0.2 percent to 68.70 Swiss francs ($56.07) in Switzerland.

Source: Associated Press/AP Online

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