ADR that result in revision of patient information
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| The United Kingdom: Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and men |
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The MHRA advises that mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.
Mycophenolate mofetil (CellCept, a prodrug of mycophenolic acid) is an immunosuppressive agent used in combination with ciclosporin and corticosteroids for the prevention of acute transplant rejection in patients who have received kidney, heart, or liver transplants.
Mycophenolate mofetil is a known teratogen; the most frequently reported congenital malformation is that of the ear. A review of worldwide cases of congenital malformations after exposure during pregnancy has confirmed mycophenolate mofetil as a powerful human teratogen, and showed evidence of an increased rate of congenital malformations and spontaneous abortions compared with other immunosuppressants. Details of the review can be found at the MHRA website.
Key updated safety advice for healthcare professionals is as follows:
• Mycophenolate mofetil or mycophenolic acid should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
• Physicians should ensure that women and men taking mycophenolate mofetil and mycophenolic acid understand: the risk of harm to a baby; the need for effective contraception; the need to plan for pregnancy and change treatment as necessary; and the need to immediately consult a physician if there is a possibility of pregnancy.
• Mycophenolate mofetil or mycophenolic acid treatment should only be initiated in women of child bearing potential when there is a negative pregnancy test result to rule out unintended use in pregnancy.
• Two serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL are recommended. The second test should be done 8–10 days after the first one and immediately before starting mycophenolate mofetil. Pregnancy tests should be repeated as clinically required (eg, after any gap in contraception is reported). Results of all pregnancy tests should be discussed with the patient.
• Mycophenolate mofetil or mycophenolic acid should only be given to women of childbearing potential who are using highly effective contraception.
• Women should use 2 forms of effective contraception during treatment and for 6 weeks after stopping treatment.
• Men (including those who have had a vasectomy) should use condoms during treatment and for at least 90 days after stopping treatment. This advice is a precautionary measure due to the genotoxicity of these products.
• Female partners of male patients treated with mycophenolate mofetil or mycophenolic acid should use highly effective contraception during treatment and for 90 days after the last dose.
Please refer to the following website in MHRA for details:http://www.gov.uk/drug-safety-update/mycophenolate-mofetil-mycophenolic-acid-new-pregnancy-prevention-advice-for-women-and-men
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, and was posted on the Drug Office website on 24 October 2015. 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 has 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. DH will maintain close contact with Roche to monitor any action deemed necessary.
So far, DH has received four adverse drug reaction cases related to the drug, 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/ Tuesday, December 15, 2015
Issued at HKT 15:00
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