其 他 安 全 警 示
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| The United Kingdom: Amiodarone (Cordarone X): Reminder of risks of treatment and need for patient monitoring and supervision (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. MHRA reminds healthcare professionals that patients should be supervised and reviewed regularly during treatment.
Amiodarone is associated with serious adverse effects in several organ systems including the eyes, gastrointestinal tract, nerves, skin, thyroid, lungs, heart, and liver. Amiodarone interacts with many medications, and advice in the relevant section of the Summary of Product Characteristics (SmPC) should be strictly followed. Amiodarone has a long plasma half-life of around 50 days, meaning that any adverse effects may persist for a month (or more) after treatment has stopped. The SmPC for amiodarone contains extensive warnings and precautions. Patients must be monitored closely during treatment.
Amiodarone can commonly cause lung inflammation (pneumonitis). In some cases, this inflammation can progress to more serious thickening or scarring (fibrosis), which can be life-threatening. Patients should be carefully evaluated clinically, and consideration given to chest X-rays before starting therapy. Symptoms of pulmonary toxicity can include shortness of breath (which may be severe and unexplained by the current cardiac status), non-productive cough, and general health deterioration (fatigue, weight loss, and fever). Pulmonary toxicity is usually (but not always) reversible following early withdrawal of amiodarone therapy, with or without corticosteroid therapy.
MHRA has received a report from a Coroner following the death by multi-organ failure of a woman who had been treated with amiodarone for approximately 5 years and who developed pneumonia during treatment. The Coroner raised a concern that there is no requirement for lung imaging to be undertaken when patients are prescribed amiodarone on a long-term basis. MHRA has conducted a review of this issue and sought independent expert advice from the Pharmacovigilance and Cardiovascular, Diabetes, Renal, Respiratory and Allergy Expert Advisory Groups of the Commission on Human Medicines. Experts involved in the review advised that regular lung imaging during treatment may expose patients to excessive radiation, be alarming for patients, and was unnecessary given that patient-reported worsening of respiratory function is usually a good first indicator of pulmonary toxicity. For this reason, it is important that patients know the symptoms of pulmonary toxicity of which to be aware and the fact this can be serious and may happen at any time during treatment (or in the month after stopping treatment). The Patient Information Leaflet is being updated to emphasise that respiratory symptoms may get progressively worse and can happen at any time after starting treatment. Additionally, the SmPC for healthcare professionals is being updated to emphasise that computerised tomography (CT) scans are more specific than X-rays and may be therefore more helpful in confirming a suspected diagnosis of lung toxicity.
Amiodarone treatment can commonly lead to hypothyroidism or hyperthyroidism, particularly in patients with a personal history of thyroid disorders in whom treatment is contraindicated. Thyroid-test levels should be checked before starting treatment, at 6-monthly intervals, and for several months following treatment discontinuation. Regular assessment is recommended in patients whose medical history indicates an increased risk of thyroid dysfunction.
Advice for healthcare professionals:
- 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 CT scans if pulmonary toxicity is suspected.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/amiodarone-cordarone-x-reminder-of-risks-of-treatment-and-need-for-patient-monitoring-and-supervision
In Hong Kong, there are 9 registered pharmaceutical products containing amiodarone. All products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to amiodarone, of which one case was related to hypothyroidism. The risk of serious adverse reactions associated with the use of amiodarone (including pulmonary toxicity, effects on the liver, hypothyroidism/hyperthyroidism) and precautions on regular patient monitoring (including pulmonary, liver and thyroid function) is documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Mar 16, 2022
Issued at HKT 15:00
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