BP drug withdrawn over liver damage fears

Pulmonary arterial hypertension (PAH) drug Thelin (sitaxentan) will be withdrawn from the market following new information on two cases of fatal liver injury.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

Renewable energy

GP practices can be 'more ambitious' on tackling climate change

GP practices can be more ambitious in taking steps to tackle climate change than...

GP surgery sign

Risks of being a partner have outstripped benefits, GPs told

The risks of being a partner have become greater that the benefits, the RCGP conference...

Image of Dr Farzana Hussain

GPs urged to use their voices to improve the lives of patients in deprived areas

The can-do attitude and independence of GPs offers a unique opportunity to help reverse...

Professor Sir Michael Marmot

Unequal impact of COVID-19 'utterly predictable' amid rising inequality, says Marmot

The disproportionate impact of COVID-19 on people in the most deprived parts of England...

Consulting room door

NHS on course for shortfall of 11,000 GPs within a decade

One in four GP and practice nurse posts will be vacant within a decade without a...

Dr Iona Heath

Lessons from the COVID-19 pandemic can help GPs tackle health inequalities

GPs can use evidence from the COVID-19 pandemic to put pressure on the government...