← Back

UK Drug Safety Update · UK · 15 Mar 2022 · Guidance

Amiodarone: reminder of risks of treatment and need for patient monitoring and supervision

AI-generated summary

The UK MHRA reminds healthcare professionals that amiodarone, used to treat abnormal heart rhythms, carries serious risks affecting multiple organ systems and requires close patient monitoring. Patients must have liver and thyroid function checked before treatment and every 6 months, with thyroid monitoring continuing for months after stopping. Patients should be aware of symptoms of lung, thyroid, and other toxicities and seek immediate medical attention if they occur. A patient card is available summarizing serious side effects and drug interactions.

From UK Drug Safety Update

Post-publication note: May 2022

A patient card is available for all patients that take amiodarone. This card includes important information on the most serious and potentially life-threatening side-effects (and their symptoms) that may occur during treatment with amiodarone and also reminds patients of the potential for drug to drug interactions.

- amiodarone can cause serious adverse reactions affecting the eyes, heart, lung, liver, thyroid gland, skin, and peripheral nervous system

- review regularly patients on long-term amiodarone treatment – some of these reactions may be life-threatening but onset can be delayed

- check liver and thyroid function before treatment, and at 6-monthly intervals; thyroid function should also be monitored for several months after discontinuation

- although routine lung imaging is not necessary in patients taking amiodarone long-term, make patients aware of the need to seek advice if they have new or worsening respiratory symptoms and consider using computerised tomography (CT) scans if pulmonary toxicity is suspected

- report suspected adverse drug reactions associated with amiodarone on a Yellow Card

Advice for healthcare professionals to give to patients and carers:

- amiodarone is used to treat serious heart conditions in which your heart beats unevenly or too fast

- always read the Patient Information Leaflet provided with your medicines and follow the advice on other medicines to avoid and what to do if you have a side effect

- your doctor may perform tests of your blood, lungs, heartbeat, and eyes before and during treatment – it’s important to have these tests because they can identify if there’s a problem

- stop taking amiodarone and see a doctor or go to a hospital straight away if you experience any of the following during treatment or in the period after stopping amiodarone:

- new or worsening shortness of breath or coughing that will not go away

- yellowing of the skin or eyes (jaundice), feeling tired or sick, loss of appetite, stomach pain, or high temperature

- weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in menstrual periods, swelling of the neck (goitre), nervousness, irritability, restlessness, or decreased concentration

- your heartbeat becomes even more uneven or erratic, or becomes very slow

- any loss of eyesight

Amiodarone and risk of toxicity

Amiodarone is used to treat certain types of abnormal heart rhythm, including atrial fibrillation and tachyarrhythmias. Amiodarone is generally reserved for situations when other treatments cannot be used or have failed. Treatment should be initiated and monitored under hospital or specialist supervision and in accordance with clinical guidance.

Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗