ADR that result in revision of patient information
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| Canada: Association of lithium with hypercalcemia and hyperparathyroidism |
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Health Canada is informing health professionals and patients of new safety information and treatment recommendations regarding the drug lithium and the risks of high blood calcium (hypercalcemia) sometimes associated with a hormone disorder known as hyperparathyroidism.
Lithium is used widely to treat mania, a psychiatric condition that is part of bipolar disorder (manic-depressive illness). It has been available in Canada for over 60 years. It is used to treat acute manic episodes, and as a long-term therapy to reduce their frequency and severity.
There is evidence that lithium affects the metabolism of calcium, which is already noted in the product labelling for lithium drugs. Lithium therapy may cause high levels of calcium in the bloodstream which may or may not be accompanied by an increased level of parathormone (also known as hyperparathyroidism). While in many cases the effects of high blood calcium and/or parathormone are unnoticeable or mild, in severe cases they can be life threatening. Severe hypercalcemia can be a medical emergency as coma and cardiac arrest can occur.
Health Canada is currently working with the companies to update the product labels for lithium drugs to include new warnings with respect to the risk of hypercalcemia and hyperparathyroidism, and the need to consider calcium monitoring before and during lithium therapy. The benefits of this drug in the treatment of bipolar disorder, a serious mental illness, continue to outweigh the known risks of this drug.
Patients are advised to talk to a healthcare professional regarding any questions or concerns they may have about their lithium treatment. Healthcare professionals are advised to consider calcium blood level before starting a patient on lithium treatment, again after six months, and on an annual basis after that, in long-term treatment. If necessary, consider measuring parathormone blood level to identify or rule out hyperparathyroidism.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../37903a-eng.php
In Hong Kong, there are eight registered pharmaceutical products containing lithium. They are prescription only medicines indicated for the treatment and prophylaxis of mania and manic-depression. So far, the Department of Health (DH) has not received any adverse reaction report in relation to the drug. In view of Health Canada’s latest announcement, a letter to inform healthcare professionals will be issued. DH will keep vigilant on any safety updates of the drug.
Ends/ Thursday, February 06, 2014
Issued at HKT 14:30
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