Worldwide withdrawal of Thelin (sitaxentan) by Pfizer
The Therapeutic Goods Administration (TGA) has advised that the supply of the prescription medicine Thelin (sitaxentan), used to treat pulmonary hypertension, has been withdrawn in Australia following overseas evidence of safety concerns.
Pfizer, the company that supplies the medicine, has announced that it will withdraw Thelin from the market globally.
This action has been taken in response to a review of safety data in clinical trials being undertaken overseas that showed patients were at risk of acute liver failure that in some cases was not reversible.
It is estimated that approximately 200 patients are currently taking this medicine in Australia. All the specialist clinical units prescribing Thelin have been contacted by the TGA and advised of this action.
The TGA has received 10 adverse event reports of abnormal liver function in Australian patients receiving Thelin.
