BP drug withdrawn over liver damage fears

Pulmonary arterial hypertension (PAH) drug Thelin (sitaxentan) will be withdrawn from the market following new information on two cases of fatal liver injury.

Ankle brachial pressure check (Photograph: SPL)
Ankle brachial pressure check (Photograph: SPL)

Manufacturer Pfizer decided to withdraw the drug after cases of unpredictable serious liver injury were reported. Clinical trials involving the drug will also be halted.

Thelin has been authorised in the EU for the treatment of OAH since 2006.

The European Medicines Agency (EMA) advised all patients taking Thelin or participating in Thelin studies not to stop treatment and to consult their treating physician to review their treatment at their next scheduled appointment.

Thelin was contraindicated in patients with mild to severe hepatic impairment and elevated aminotransferases prior to initiation of treatment since its authorisation.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) will examine the issue during their next meeting on 13-16 December 2010 and will provide detailed advice for patients and prescribers.

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