Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury

Last Updated on December 13, 2010 by Joseph Gut – thasso

December 13, 2010 – We learn today that the European Medicines Agency (EMEA) has been informed of Pfizer’s decision to voluntarily withdraw Sitaxentan [Thelin] from the market worldwide further to new information on two cases of fatal liver injury. Pfizer has also decided to discontinue all ongoing clinical trials.

Sitaxentan [Thelin], has been authorised in the European Union (EU) since 2006 for the treatment of pulmonary arterial hypertension (PAH). Sitaxentan [Thelin] was marketed in 16 European Union (EU) Member States, in Australia and in Canada.

Sitaxentan [Thelin] has been known to be associated with liver toxicity and since its initial marketing authorisation has been contra-indicated in patients with mild to severe hepatic impairment (Child-Pugh Class A-C) and elevated aminotransferases prior to initiation of treatment.

At this stage, patients taking Sitaxentan [Thelin] or participating in Sitaxentan [Thelin] studies are advised not to stop treatment and to consult their treating physician to review their treatment at their next scheduled appointment.

The Agency’s scientific Committee for Medicinal Products for Human Use (CHMP) will look at this issue during their plenary meeting on 13–16 December 2010 and will provide detailed advice for patients and prescribers.

There exist alternatives for the therapy of pulmonary arterial hypertension (PAH), among them, and depending on their availability in the different markets worldwide, Bosentan (Tracleer), Sildenafil [Revatio], Ambrisentan [Letairis, EU trade name Volibris], and Tadalafil [Adcirca].

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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.