Novartis withdraws Zelnorm under T-IND

Novartis, the firm that manufactures Zelnorm, which treats irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women under 55, has said it will no longer provide the drug under a treatment investigational new drug application protocol (T-IND), reports say.

According to PharmaLive, the drug, which was approved in 2002, was suspended by the company on March 30th 2007 after safety analysis discovered its use puts patients at a higher risk of heart attack, stroke and unstable angina.

Novartis has, however, agreed to make Zelnorm available for use in emergency situations, where life is immediately threatened or where a patient’s condition is severe enough to merit hospitalisation.

However, requests for use of the drug under these circumstances must still be approved by authorities before it can be shipped.

The site adds that the Food and Drug Administration may still refuse to sanction the drug’s use – even in life-threatening situations – if there is evidence indicating that its application may pose an “unreasonable or significant” risk to patients.

Novartis was formed in 1996 by a merger between Ciba-Geigy and Sandoz. Its worldwide headquarters is in Basel, Switzerland.