Other safety alerts
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| Singapore: CellCept® (mycophenolate mofetil): teratogenic risk – important new pregnancy prevention advice for women and men |
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The Singapore Health Sciences Authority (HSA) announced that Roche would like to inform healthcare professionals of important new pregnancy prevention advice for women and men taking CellCept® (mycophenolate mofetil).
This recommendation follows cumulative review of birth defects which provided evidence of an increased rate of congenital malformations and spontaneous abortions associated with mycophenolate in comparison with other medicines. CellCept® is now contraindicated during pregnancy due to its mutagenic and teratogenic potential, in women of childbearing potential not using highly effective contraceptive methods and in women who are breastfeeding.
Physicians are advised to ensure that women and men taking CellCept® understood the risk of harm to baby, the need for effective contraception and the need to immediately consult a physician if there is a possibility of pregnancy. Before starting CellCept® therapy, women of childbearing potential must have two negative serum or urine pregnancy tests where the second test should be performed 8 to 10 days after the first one and immediately before starting CellCept®. The Singapore package insert for CellCept® has been strengthened on the above warnings and contraindications.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../cellcept-mycophenolatemofetilteratogenicriskimportantnewpregnanc.html
In Hong Kong, there are 17 registered pharmaceutical products containing mycophenolate mofetil or mycophenolic acid. All products are prescription only medicines. Related news was issued by the EMA, MHRA TGA and Health Canada, and was posted on the Drug Office website on 24 October 2015, 15 December 2015, 22 December 2015 and 19 January 2016 respectively. Letters to inform local healthcare professionals of the new advice to prevent pregnancy when using the products were issued on 26 October 2015.
Roche Hong Kong Limited (Roche) is the registration certificate holder of four branded pharmaceutical products containing mycophenolate mofetil, namely CellCept Cap 250mg (HK-41757), CellCept Tab 500mg (HK-44333), CellCept Powder for Infusion 500mg (HK-45089) and CellCept Powder for Oral Suspension 1g/5ml (HK-62451). On 7 December 2015, Roche notified the Department of Health (DH) that the company had issued a "Dear Healthcare Professional Letter" to inform local healthcare professionals about the teratogenic risk of the products, with important new pregnancy advice for women and men.
So far, DH has received six adverse drug reaction cases related to mycophenolic acid, and one of them was related to missed abortion after taking the drug. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, March 16, 2016
Issued at HKT 17:00
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