Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

Adverse drug events

Hepatitis C drugs hit by incompatibility warnings

Gilead hepatitis C drugs Harvoni and Sovaldi and Bristol-Myers Squibb’s Daklinza warning drug regulators incompatibility with amiodarone.

Source: Shutterstock

Gilead’s hepatitis C drugs Harvoni and Sovaldi and Bristol-Myers Squibb’s Daklinza have been hit by warnings from US and European regulators regarding their incompatibility with the antiarrhythmic amiodarone.

The European Medicines Agency (EMA) confirmed on 24 April 2015 that Harvoni (sofosbuvir and ledipasvir) or a combination of Sovaldi (sofosbuvir) and Daklinza (daclatasvir) pose a risk of severe bradycardia or heart block in patients treated with amiodarone.

Concerns around the drug combinations have arisen since their approval in 2014 in the United States and the EU. Among eight cases of potential adverse drug events reviewed up to April 2015, one resulted in a fatal cardiac arrest and two required pacemaker intervention.

After considering the evidence at its 20–23 April 2015 meeting, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended that amiodarone should only be used in patients receiving these hepatitis C treatment combinations if other antiarrhythmics cannot be given. Such patients must be monitored closely, as should patients who begin these treatments within a few months of stopping amiodarone, given its lasting effect.

The US Food and Drug Administration (FDA) made similar recommendations in a communication dated 24 March 2015, in response to a warning letter issued by Gilead four days earlier.

Both the FDA and EMA echo Gilead’s statement that the “mechanism of potential interaction between amiodarone and Harvoni, or Sovaldi in combination with any other direct-acting antiviral is unknown”. Gilead also notes that it is “not possible to estimate the incidence of these events”, since the number of patients taking these drug combinations is unknown. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068454

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Handbook of Drug Administration via Enteral Feeding Tubes

    Handbook of Drug Administration via Enteral Feeding Tubes

    All you need to know about prescribing or administering drugs via enteral feeding tubes. Over 400 drug monographs as well as facts to inform clinical decision making.

    £54.00Buy now
  • Prescribing Medicines for Children

    Prescribing Medicines for Children

    Prescribing Medicines for Children is designed to improve understanding on all aspects of paediatric prescribing, from the development of suitable drugs through to their practical administration.

    £60.00Buy now
  • Drugs in Use

    Drugs in Use

    Optimise drug therapy for your patients. These case studies help you bridge the gap between theoretical medicines knowledge and practical applications.

    £43.00Buy now
  • Palliative Care Formulary (PCF6)

    Palliative Care Formulary (PCF6)

    Palliative Care Formulary is a comprehensive combination of independent information about drugs used in palliative care.

    £55.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.