Medicine recalls
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| Canada: BRAVELLE (75 IU urofollitropin for injection, purified) - Recalled lots due to reduced therapeutic effect |
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Ferring Inc. Canada, in consultation with Health Canada, would like to inform health care professionals of a voluntary recall of four (4) lots of BRAVELLE (lot no.: H15940B, H15940C, K16990B and K16990C). The recall is due to reduced potency of the product detected during routine stability testing.
BRAVELLE in conjunction with human chorionic gonadotropin (hCG) is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression including patients participating in an Assisted Reproductive Technology (ART) program.
During routine stability testing, out of specification analytical results (reduced potency) were obtained for follicle stimulating hormone (FSH) potency on certain lots of BRAVELLE. The out of specification results occurred between 12 to 24 months. Approved shelf-life in Canada is 24 months when stored between 15°C and 25°C and protected from light. As a result, the described quality issue concerns "reduced therapeutic effect" and it is evaluated that the medical consequences for a female patient exposed could be lack of/decreased follicle stimulation (ovulation) with decreased or lack of clinical effect. This is not likely to cause adverse health consequences to the female patients exposed. However, there is the potential for unnecessary over-exposure of patients in establishing an effective dose.
Ferring Inc. Canada is recalling the affected lots and a projected re-stocking date has not yet been determined. The company is investigating the issue to further determine the root cause and will implement necessary corrective and preventive actions.
If there is a shortage of BRAVELLE, the treating fertility physician should use their discretion and should weigh the benefits and risks of using another product or defer therapy until the supply resumes. For patients who have not yet started on BRAVELLE there are other options for treatment with FSH. FSH products available on the market are not deemed interchangeable.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/55560a-eng.php
In Hong Kong, Bravelle Powder and Solvent for Inj 75IU (HK-58374) is a pharmaceutical product registered by Ferring Pharmaceuticals Ltd (Ferring), and is a prescription-only medicine. Related news has been issued by the MHRA, and was posted on the Drug Office website on 23 October 2015. So far, the Department of Health (DH) has not received any adverse drug reaction case on the product. As confirmed with Ferring, the affected batches in Canada have not been imported into Hong Kong. As previously reported, Ferring has quarantined the remaining products on hand as a precautionary measure, while awaiting the company's investigation result. DH will remain vigilant on the progress of the incident and safety updates by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Monday, October 26, 2015
Issued at HKT 15:00
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