引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Canada: Association of Relistor (methylnaltrexone bromide) subcutaneous injection with gastrointestinal (GI) perforation (English only) |
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Wyeth Canada (a Pfizer Company) inform healthcare professionals of important new safety information added to the Product Monograph for Relistor (methylnaltrexone bromide) Subcutaneous Injection. Relistor is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care. Patients with advanced illness being treated with Relistor may be at increased risk of GI perforation if they have conditions associated with localized or diffused reduction of structural integrity in the GI wall, these include conditions such as cancer, GI malignancy, GI ulcer, Ogilvie’s syndrome, and concomitant medications (e.g. bevacizumab, nonsteroidal anti-inflammatory drugs and steroids). The risks and benefits of Relistor treatment should be weighed for each patient. Relistor should be used with caution in patients with known or suspected GI lesions.
Please refer to the following website in the Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/relistor_hpc-cps-eng.php
In Hong Kong, Relistor is registered by Wyeth (HK) Ltd. The company confirms that Relistor has not been imported into Hong Kong since its registration in July last year; and the company has been instructed to update its package insert with the above safety information before Relistor is marketed in Hong Kong.
Ends/Wednesday, August 4, 2010
Issued at HKT 12:30
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