Other safety alerts
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| Canada: Alesse 21 and Alesse 28: Packages containing broken or split tablets |
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Further to the public advisory that was issued on 1 Dec 2017, Health Canada would like to provide further information to assist healthcare professionals in advising their patients who use Alesse.
Health Canada and Pfizer Canada Inc. have received reports for packages of Alesse 21 and Alesse 28 where the blister packages contained a single active (pink) tablet that was broken. This could reduce the dose of hormones and potentially result in an unintended pregnancy due to insufficient action of the contraceptive hormones levonorgestrel and ethinyl estradiol. The Alesse 21 consists of 21 pink tablets containing active ingredients. Alesse 28 consists of 21 pink tablets containing active ingredients, followed by 7 days of white tablets containing placebo.
During manufacturing, it is possible for tablets to break or split. However, as the manufacturing process is well controlled, these problems rarely occur and Pfizer considers these cases to be isolated incidents. The overall quality of the intact tablets is not affected.
Healthcare professionals are advised to remind the patients to:
- check tablets before taking them and not consume tablets that are broken or split;
- return blister packages containing broken or split tablets to the pharmacy to get a replacement package; and
- seek counsel on the proper use of oral contraceptives, and on what to do if they miss a dose.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../65368a-eng.php
In Hong Kong, Loette Tab (HK-53602) is a pharmaceutical product registered by Pfizer Corporation Hong Kong Limited (Pfizer) containing the same active ingredients as Alesse 21, and is a prescription-only medicine. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 4 Dec 2017. As confirmed with Pfizer, the manufacturer of Loette Tab is different from Alesse, therefore, there is no impact on the products marketed in Hong Kong.
Ends/Tuesday, Dec 12, 2017
Issued at HKT 15:00
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