Thelin withdrawn following liver safety review

Thelin (sitaxentan) has been withdrawn from markets worldwide following a reassessment of its liver safety profile by the Committee for Medicinal Products for Human Use (CHMP).

Thelin was approved in 2006 for the treatment of pulmonary arterial hypertension. The safety reassessment was prompted by three cases of fatal liver injury, two of which were causally related to use of the endothelin A receptor antagonist. The cases were not associated with identifiable risk factors and were not detected by frequent monitoring, indicating that serious liver damage cannot be prevented in all patients.

The CHMP is initiating a cumulative review of all endothelin receptor antagonists to determine whether hepatic toxicity is a class effect.

Alternative treatments for patients currently receiving Thelin include the endothelin antagonists Tracleer (bosentan) and Volibris (ambrisentan). Thelin will be withdrawn using a phased approach to enable a safe switch to alternative treatment.

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

MIMS Product Slides

Product overviews prepared by the MIMS team, in a handy slide format.

Click here

Slides are initiated, funded & reviewed by the companies specified.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases