BP drug withdrawn over liver damage fears

Pulmonary arterial hypertension (PAH) drug Thelin (sitaxentan) will be withdrawn from the market following new information on two cases of fatal liver injury.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

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register

Already registered?

Sign in

Follow Us:

Just published

Proportion of NHS GPs trained in EEA stabilises despite Brexit uncertainty

Proportion of NHS GPs trained in EEA stabilises despite Brexit uncertainty

The proportion of NHS GPs trained in the EEA has stabilised after a steady decline...

GPs split on calls to suspend appraisal for duration of pandemic

GPs split on calls to suspend appraisal for duration of pandemic

Senior GPs are divided over calls for appraisal to be halted for the rest of the...

GP fears rising over covert recording of consultations in pandemic

GP fears rising over covert recording of consultations in pandemic

Fears over patients covertly recording consultations have increased among GPs since...

Coronavirus: Key guidance GPs need to know about COVID-19

Coronavirus: Key guidance GPs need to know about COVID-19

GPonline provides an overview of the key guidance relating to coronavirus, including...

Care home vaccination to begin as Scottish minister says Pfizer vaccine packs can be split up

Care home vaccination to begin as Scottish minister says Pfizer vaccine packs can be split up

Vaccination of care home residents against COVID-19 will start on 14 December in...

How will the COVID-19 vaccination programme get underway?

How will the COVID-19 vaccination programme get underway?

Following the MHRA's approval of Pfizer/BioNTech's COVID-19 jab the government has...