Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Dronedarone linked to liver injury

The manufacturer of dronedarone (Multaq®) has written to healthcare professionals warning of severe liver injury associated with use of the drug. The Medicines and Healthcare products Regulatory Agency (MHRA) have also issued a warning (PDF).

Dronedarone is licensed for use in clinically stable patients with a history of or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or lower ventricular rate.

Cases of liver injury have been reported with 2 cases requiring transplantation. Liver function tests are advised before starting treatment, on a monthly basis for 6 months, at 9 and 12 months after initiation and periodically thereafter. Patients who are already on treatment should also undergo liver function testing based on this advised frequency of testing.

If alanine transferase (ALT) is elevated to greater than three times the upper limit of normal the level should be rechecked within 48-72 hours and if confirmed treatment should be withdrawn.

Action: Clinicians should be aware of this warning and the new monitoring requirements. The manufacturer will be updating the prescribing information shortly.

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7 Comments to “Dronedarone linked to liver injury”

  1. Been on Dronedarone for last 2.5 yrs and all's fine. On Sotalol previously and in and out of A.F., but Dronedarone has improved my quality of life tremendously, despite minor suspected side-effects.

    Comment by Alun RhysJones — February 7, 2013 #
    Reply

  2. That decreases your heart's power to pump blood accurately all over one's human body. Consequently, the center muscle turns into enlarged and is also also further weakened.

    Comment by Spencergagee — September 9, 2011 #
    Reply

  3. Dronedarone: Uses and Side Effect

    Dronedarone is a medication used to treat two kinds of heart disorders: atrial fibrillation or the fast and irregular beating of the heart and atrial flutter or the fast but regular beating of the heart. These two occur in the upper atria or upper chambers of the heart.

    http://heart-consult.com/articles/dronedarone-uses-and-side-effects

    Comment by Manu — April 16, 2011 #
    Reply

  4. Dronedarone has been mentioned as having a harmful effect on liver but the use of the drug also has some other side effects too
    itching,redness,Some serious side effects which require medical attention include
    shortness of breath,wheezing,chest tightness,coughing up frothy mucus
    http://heart-consult.com/articles/dronedarone-uses-and-side-effects

    Comment by Josgreg — February 19, 2011 #
    Reply

  5. [...] anti-arrhythmic dronadarone has been linked with liver toxicity and increased monitoring has been recommended. It is also associated with an increased risk of new onset heart failure and worsening of symptoms [...]

    Pingback by Prescribing Advice For GPs » Drug Safety Update – February 2011 — February 14, 2011 #
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  6. […] anti-arrhythmic dronadarone has been linked with liver toxicity and increased monitoring has been recommended. It is also associated with an increased risk of new onset heart failure and worsening of symptoms […]

    Pingback by Drug Safety Update – February 2011 | Prescribing Advice For GPs — February 14, 2011 #
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  7. Hi
    This is what Prescrire wrote about dronedarone in August 2010:
    http://english.prescrire.org/en/81/168/46453/0/NewsDetails.aspx

    Dronedarone in atrial fibrillation: too many questions about long-term adverse effects

    FEATURED REVIEW In patients with atrial fibrillation, dronedarone has less antiarrhythmic efficacy than amiodarone but fewer short-term adverse effects. Little is known of potential long-term adverse effects, but dronedarone has been linked to increased mortality in patients with heart failure. When antiarrhythmic drug therapy is needed, it is better to continue to use a beta blocker or, as a last resort, amiodarone, a drug with better-documented adverse effects, especially during long-term treatment.
    Full review (4p) available for download by subscribers.

    Abstract

    * In patients with atrial fibrillation, a beta blocker is generally used initially to prevent recurrence or to slow the heart rate. Amiodarone is a last resort, mainly because of its numerous adverse effects.

    * Dronedarone, chemically similar to amiodarone, was recently authorised for this indication in the European Union.

    * In a double-blind trial versus amiodarone in 504 patients, the failure rate was significantly higher with drone darone (75.1% versus 58.8%).

    * Two placebo-controlled trials in heart failure patients yielded conflicting results. Dronedarone was associated with a statistically significant increase in mortality in a trial in 627 symptomatic patients free of arrhythmias. However, there was no statistically significant difference in a trial including 4630 patients with atrial fibrillation and a lower risk of cardiovascular events.

    * There are no comparative trials versus other antiarrhythmic drugs or heart-rate-lowering agents, including betablockers and calcium channel blockers.

    * Like other antiarrhythmic drugs, dronedarone also has arrhythmogenic effects, including bradycardia and QT prolongation. Other adverse effects include diarrhoea, nausea and vomiting, and cutaneous disorders. Transient elevation of creatinine levels is also frequent, and cases of renal failure have been reported.

    * In the trial versus amiodarone, dronedarone had a different pattern of short-term adverse effects, including more gastrointestinal disorders but less frequent thyroid disorders, neurological disorders, hypersensitivity reactions, hypertension, and QT prolongation. Little is known of potential long-term adverse effects, especially pulmonary fibrosis.

    * In practice, dronedarone is better tolerated but less effective than amiodarone in the short term. When antiarrhythmic drug therapy is needed, it is better to continue to use a beta blocker or, as a last resort, amiodarone, a drug with better-documented adverse effects, especially during long-term treatment.

    ©Prescrire August 2010

    "Dronedarone in atrial fibrillation: too many questions about long-term adverse effects" Prescrire Int 2010; 19 (108): 149-452 (pdf, subscribers only).

    Comment by Christophe Kopp — January 25, 2011 #
    Reply

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