Other safety alerts
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| Canada: Summary Safety Review - Gilenya (fingolimod) - Assessing the potential risk of worsening multiple sclerosis symptoms after product withdrawal (rebound effect) |
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Health Canada announces that it reviewed the potential risk of worsening multiple sclerosis (MS) symptoms (rebound effect) after Gilenya withdrawal. The safety review was triggered by reports of severe MS symptoms following the withdrawal of Gilenya. Severe worsening of MS symptoms were mostly reported within 12 weeks (with rare cases reported up to 24 weeks) following withdrawal of Gilenya.
At the time of the review, Health Canada identified 29 international reports of severe worsening of MS disease progression after Gilenya withdrawal. Most patients (27/29) required treatment for the symptoms they experienced and, at the time of reporting, the majority of patients partially recovered following treatment with other agents (18/27). Twelve of these 29 patients required hospitalization. This safety review also looked at information from the manufacturer and the scientific literature about the risk of rebound effect after Gilenya withdrawal. The information from the manufacturer and the scientific literature supported the potential risk of worsening MS symptoms after Gilenya withdrawal.
Product information for Gilenya now includes information about the risk of worsening MS symptoms after Gilenya withdrawal. It also recommends monitoring patients for development of severe worsening of MS symptoms after withdrawal of Gilenya and beginning appropriate treatment as needed. This information can be found in the Warnings and Precautions section of the product information for Gilenya.
Health Canada’s safety review concluded that there may be a link between the withdrawal of Gilenya and the worsening of MS symptoms (rebound effect). The product safety information for Gilenya has been updated to inform Canadians and healthcare professionals about this potential safety issue.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00219
In Hong Kong, Gilenya Hard Capsules 0.5mg (HK-61192) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to fingolimod, but these cases are not related to worsening of multiple sclerosis after stopping the drug. Related news was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 21 Nov 2018. Letters to inform local healthcare professionals were issued by DH on the same day. In Feb 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of the product should include the safety information on severe worsening of multiple sclerosis after stopping the drug. DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Mar 1, 2019
Issued at HKT 16:00
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