Novartis Pharmaceuticals Pty Ltd—Zelmac tegaserod 6mg tablet blister pack

PRA number

2007/9181

Published date

Product description

All batches.
Identifying features
ARTG No. 77325.

Other identifying numbers

ARTG No. 77325.

What are the defects?

A recent retrospective analysis of pooled clinical trial data showed that the incidence of cardiovascular ischemic events in patients taking Zelmac was higher than in those taking placebo.

What are the hazards?

Potentially life-threatening or a serious risk to health (Class I).

What should consumers do?

Letters were dispatched to doctors, pharmacies, and hospital pharmacies commencing 4 April 2007.

Supplier

Novartis Pharmaceuticals Pty Ltd

Where the product was sold

Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category