ADR that result in revision of patient information
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| Canada: Summary Safety Review - Oral prednisone and prednisolone (glucocorticoids) - Assessing the potential risk of a serious complication called scleroderma renal crisis in patients with systemic sclerosis |
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Health Canada announces that it reviewed the potential risk of scleroderma renal crisis (SRC) with the use of oral prednisone and prednisolone products in patients with systemic sclerosis. The review was triggered after the European Medicines Agency (EMA) updated the product safety information for oral and injectable prednisone and prednisolone products on 6 Jul 2017 to include this risk.
Systemic sclerosis (also known as scleroderma) is a rare disease involving an abnormal response from the body's immune system. The disease causes changes in the texture and appearance of the skin, and frequently involves the internal organs. Scleroderma renal crisis is a life-threatening complication of systemic sclerosis that frequently involves severe high blood pressure and declining function of the kidneys.
Prednisone and prednisolone are available in Canada in a variety of forms and combinations. The current review focused only on prednisone and prednisolone products for oral use since this route delivers higher doses of the product throughout the body. Injectable prednisone and prednisolone are not marketed in Canada.
At the time of the review, Health Canada had received 2 Canadian reports of SRC related to the use of prednisone (none for prednisolone). In both reports, there was a possible link found between SRC and the use of prednisone. No Canadian deaths were reported. This review also looked at 6 published international reports of SRC related to the use of prednisone (1 report) and prednisolone (5 reports). In all 6 reports, there was a possible link found between SRC and the use of prednisone or prednisolone, especially at higher doses. Of the 6 international reports, 3 involved death. A possible link between death and the use of prednisolone was found in 1 of these cases. The remaining 2 cases could not be assessed as there was not enough information. Seven out of 8 possible cases of prednisone and prednisolone associated with SRC had other factors present (i.e. medical conditions, other medications) that could have caused SRC. A review of the scientific literature found 6 published studies and 3 review articles that supported an increased risk of SRC in patients with systemic sclerosis treated with prednisone or prednisolone, especially at higher doses.
Health Canada's review of the available information has concluded that there may be a link between the use of oral prednisone and prednisolone products, especially at higher doses, and SRC in patients with systemic sclerosis. Health Canada will be working with the manufacturers to update the Canadian product safety information for oral prednisone and prednisolone products to inform about this risk.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00208
In Hong Kong, there are 4 registered pharmaceutical products containing prednisone, and all of them are oral products. There are also 45 registered oral products and 1 registered injectable product containing prednisolone. All products are prescription-only medicines. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction related to prednisone and 41 cases related to prednisolone, but these cases are not related to SRC. In light of the above Health Canada’s announcement, letters to inform local healthcare professionals to draw their attention on the potential risk will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Aug 8, 2018
Issued at HKT 16:00
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