EMA warns against use of riociguat in PH-IIP type pulmonary hypertension

EMA warns against use of riociguat in PH-IIP type pulmonary hypertension

June 29 2016 Adempas (riociguat) should not be used in patients with symptomatic pulmonary...

2015-16 flu vaccine effectiveness assessed in PHE report

2015-16 flu vaccine effectiveness assessed in PHE report

June 27 2016 The 2015-16 influenza vaccine effectiveness has been calculated at 57.6% in children...

Only fluoxetene considered of value in childhood major depressive disorder

Only fluoxetene considered of value in childhood major depressive disorder

June 15 2016 The bulk of commonly used antidepressants appear to have little value in the acute...

Weigh up risk of initiating antiepileptic therapy after an initial seizure, suggests Cochrane

Weigh up risk of initiating antiepileptic therapy after an initial seizure, suggests Cochrane

May 11 2016 Initiating antiepileptic drug therapy in someone who has had a first unprovoked...

  • EMA warns against use of riociguat in PH-IIP type pulmonary hypertension

    EMA warns against use of riociguat in PH-IIP type pulmonary hypertension

    Wednesday, 29 June 2016 10:44
  • 2015-16 flu vaccine effectiveness assessed in PHE report

    2015-16 flu vaccine effectiveness assessed in PHE report

    Tuesday, 28 June 2016 13:29
  • Only fluoxetene considered of value in childhood major depressive disorder

    Only fluoxetene considered of value in childhood major depressive disorder

    Wednesday, 15 June 2016 10:50
  • Final results from FLAME study confirms superiority of Ultibro Breezhaler over Seretide Accuhaler for reducing COPD exacerbations

    Final results from FLAME study confirms superiority of Ultibro Breezhaler over Seretide Accuhaler...

    Tuesday, 17 May 2016 12:01
  • Weigh up risk of initiating antiepileptic therapy after an initial seizure, suggests Cochrane

    Weigh up risk of initiating antiepileptic therapy after an initial seizure, suggests Cochrane

    Wednesday, 11 May 2016 11:32

drugalertJune 29 2016

Adempas (riociguat) should not be used in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia or PH-IIP, the European Medicines Agency has warned.

Although the drug is not authorised for use in PH-IIP patients, the EMA has issued the recommendation following the early termination of a phase II clinical trial, RISE-IIP, investigating the effects of Adempas in this patient population.

“Preliminary results showed an increased number of deaths and serious adverse events, including breathing problems and lung infections, with Adempas compared with placebo. The available data do not indicate a clinically significant benefit from Adempas treatment in these patients,” said the EMA’s announcement, published on June 24.

The trial had been assessing the medicine in 145 PH-IIP patients, with the primary endpoint being the change in the 6-minute walking distance test after 6 months of treatment. “At the time of the interim assessment leading to the termination of the trial, 21 deaths had been observed, 17 patients taking Adempas and 4 patients taking placebo. Serious adverse events, which were mostly respiratory disease or lung infections, were also higher among patients taking Adempas.”

EMA is advising health professionals that “if any patients with PH-IIP are being treated with Adempas, this treatment should be discontinued and the patient’s clinical status carefully monitored.” A contraindication will also be included in prescribing information, and EMA will be issuing a letter to health professionals. 

It has also stated that Adempas continues to have a positive benefit-risk balance for its authorised uses.

The product’s indications in the UK are:

  • treating adults with WHO Functional Class (FC) II to III with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity
  • as monotherapy or in combination with endothelin receptor antagonists for adults with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.

Links:

EMA announcement

Adempas SPC on eMC

Clinical News

June 29 2016 New guidance for healthcare professionals to support pregnant women experiencing nausea and vomiting and hyperemesis gravidum have been published.
December 10 2015 A doctor may find themselves the subject of an investigation at any time in their career, from medical students to trainee doctors, GPs or consultants. Whether it’s an issue...