PRA number
2004/7266
Published date
Product description
(TGA R2004/1226-9). Vioxx (Rofecoxib)tablets 12.5mg, (AUST R 69872). Vioxx (Rofecoxib) tablets 25mg (AUST R 69871). Vioxx (Rofecoxib) oral suspension 12.5mg/5mL (AUST R 69870). Vioxx (Rofecoxib) oral suspension 25mg/5mL (AUST R 69869). All batches.
Reasons the product is recalled
The company has decided to recall Vioxx based on new information from a recent clinical study which showed that there was an increased risk of cardiovascular events such as heart attack and stroke beginning after 18 months of treatment.
The hazards to consumers
Increased risk of cardiovascular and cerebrovascular disease. (Heart Attack and Stroke).
What consumers should do
Consumers to call the Merck Sharp & Dohme Customer Service Line on 1800 066 426.
Supplier
Merck Sharp & Dohme Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.