Doxycycline should not normally be used for STI post-exposure prophylaxis

Doxycycline should not normally be used for STI post-exposure prophylaxis

November 10 2017 Doxycycline should not be used for post-exposure prophylaxis (PEP) for sexually...

MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

October 31 2017 The medicines regulator has issued four drug safety updates (DRU) relating to...

Pneumococcal polysaccharide vaccine shortage prompts advice about prioritisation

Pneumococcal polysaccharide vaccine shortage prompts advice about prioritisation

October 23 2017 A shortage of the pneumococcal polysaccharide vaccine has promoted a Chief...

PHE issues guide on sepsis in children for health visitors and school nurses

PHE issues guide on sepsis in children for health visitors and school nurses

October 10 2017 A new guide setting out information around sepsis in children has been published...

MHRA issues Drug Safety Updates for loperamide and miconazole

MHRA issues Drug Safety Updates for loperamide and miconazole

October 4 2017 The medicines regulator, the MHRA, has issued Drug Safety Updates on two...

  • Doxycycline should not normally be used for STI post-exposure prophylaxis

    Doxycycline should not normally be used for STI post-exposure prophylaxis

    Friday, 10 November 2017 17:31
  • MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

    MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

    Tuesday, 31 October 2017 20:27
  • Pneumococcal polysaccharide vaccine shortage prompts advice about prioritisation

    Pneumococcal polysaccharide vaccine shortage prompts advice about prioritisation

    Monday, 23 October 2017 09:39
  • PHE issues guide on sepsis in children for health visitors and school nurses

    PHE issues guide on sepsis in children for health visitors and school nurses

    Tuesday, 10 October 2017 13:34
  • MHRA issues Drug Safety Updates for loperamide and miconazole

    MHRA issues Drug Safety Updates for loperamide and miconazole

    Wednesday, 04 October 2017 17:04

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

November 22 2017 The public and health professionals are being asked to consider reporting side effects from over the counter medicines via the Yellow Card scheme.
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...