Summary Safety Review - Desloratadine - Assessing the potential risk of abnormal heart rhythm (QT interval prolongation)

August 10, 2017

Product

Desloratadine (Aerius and generics)

Potential Safety Issue

Abnormal heart rhythm (QT interval prolongation)

Key Messages

  • Desloratadine is available as an ingredient in some over-the-counter (OTC) products (marketed as Aerius and generics) used for the relief of allergy symptoms.
  • Health Canada carried out a safety review following international cases of abnormal heart rhythm (QT interval prolongation) suspected of being associated with the use of desloratadine.
  • Health Canada's review of the available information did not establish a link between the use of desloratadine and abnormal heart rhythm. Health Canada will continue to monitor the safety of desloratadine-containing products.

Overview

Health Canada carried out a safety review to look at the potential risk of abnormal heart rhythm (QT interval prolongation) with the use of over-the-counter (OTC) desloratadine-containing products. This safety review was triggered by a publication, in the World Health Organization (WHO) Pharmaceuticals NewsletterFootnote 1 , describing cases of abnormal heart rhythm suspected to be associated with the use of loratadine and desloratadine. Health Canada already carried out a safety review for loratadine in 2016. This safety review focused on desloratadine.

Use in Canada

  • In Canada, desloratadine is an ingredient found in some OTC products that relieve symptoms of seasonal allergy or allergy caused by pollen or dust (hay fever) such as sneezing, runny or itchy nose, itchy watery burning eyes, as well as allergic skin conditions.
  • Desloratadine has been marketed in Canada since 2001 under the brand name Aerius. Generic versions are also available. It is available in tablets or syrup.

Safety Review Findings

  • At the time of the review, Health Canada had received 10 Canadian reports of abnormal heart rhythm suspected to be associated with desloratadine use. Of these, 1 case was further assessed. The review of this case found a possible link between desloratadine and abnormal heart rhythm. However, other factors such as drugs used at the same time may have played a role. The remaining 9 reports were excluded from further review because the test results to confirm the abnormal heart rhythm were not reported.
  • In addition, Health Canada reviewed 13 international reports of abnormal heart rhythm suspected to be associated with the use of desloratadine that were provided by the manufacturer. Of these, 4 reports were further assessed as the test results to confirm the abnormal heart rhythm were reported. A link between these 4 reports and the abnormal heart rhythm could not be established due to other factors that may have played a role such as other drugs used at the same time, other underlying heart conditions or taking greater than the recommended dose of desloratadine. The remaining 9 reports were excluded from further review because the test results to confirm the abnormal heart rhythm were not reported.
  • A search in the World Health Organization's Adverse Drug Reaction Database found 35 cases of abnormal heart rhythm suspected to be associated with desloratadine use. A link between the use of desloratadine and the abnormal heart rhythm could not be established, because there was not enough information in the reports to draw conclusions.
  • Published scientific studies have shown that desloratadine is not associated with abnormal heart rhythm in humans.

Conclusions and Actions

  • Health Canada's review of the available information did not establish a link between the use of desloratadine and abnormal heart rhythm.
  • Health Canada will continue to monitor safety information involving desloratadine, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this health product in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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