ADR that result in revision of patient information
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| European Union: EMA recommends additional measures to prevent use of mycophenolate in pregnancy |
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The European Medicines Agency (EMA) has warned that the transplant medicine mycophenolate (authorised centrally as CellCept and nationally under various names) must not be used in pregnancy unless no suitable alternative is available to prevent transplant rejection. This follows a routine re-assessment of the benefits and safety of these medicines, which provided updated evidence on the risk of birth defects and spontaneous abortions when pregnant women were exposed to the medicine.
Mycophenolate (mycophenolate mofetil or mycophenolic acid) is an immunosuppressant (a medicine that suppresses the action of the immune system, the body’s natural defences). It is approved for use with other medicines to prevent rejection of the transplanted organ in patients given a kidney, heart or liver transplant. In the EU, mycophenolate mofetil has been authorised centrally as CellCept and other names since 1996, and mycophenolate has also been authorised through various national procedures.
Although the product information for these medicines already contains warnings against use in pregnancy, these will now be significantly strengthened by the addition of new contraindications, advice and information. Updated product information will emphasise that women and men using the medicine should use effective contraception and that pregnancy tests should be used before and during treatment as needed to rule out unintended pregnancy. In addition, doctors should properly explain the risks to patients and their partners, and educational material will be produced for patients and healthcare professionals to assist with this.
Detail information for patients and healthcare professionals can be found in the EMA's website.
EMA’s recommendations are based on the assessment of updated evidence on the teratogenic risks.
• A cumulative review found that around 45 to 49% of pregnancies in women exposed to mycophenolate resulted in spontaneous abortion, compared with reported frequencies of 12 to 33% in solid organ transplant patients treated with other immunosuppressants.
• The reported incidence of malformation in the offspring of mothers exposed to mycophenolate during pregnancy is 23 to 27% compared with 4 to 5% in transplant patients treated with other immunosuppressants, and 2 to 3% in the overall population. Malformations associated with mycophenolate have included abnormalities of the ear, eye and face, congenital heart disease including septal defects, polydactyly or syndactyly, tracheo-oesophageal malformations such as oesophageal atresia, effects on the nervous system such as spina bifida, and renal abnormalities.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002418.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 17 registered pharmaceutical products containing mycophenolate mofetil or mycophenolic acid. All products are prescription-only medicines. So far, the Department of Health (DH) has received three cases of adverse drug reaction on the drug, and one of them was related to missed abortion after taking the drug. In view of the EMA's announcement, letters to inform local healthcare professionals of the risk will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board. The DH will remain vigilant on any safety updates of the drug by other overseas drug regulatory authorities.
Ends/ Saturday, October 24, 2015
Issued at HKT 12:00
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). Roche notified DH that the company is going to issue a "Dear Healthcare Professional Letter" today 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. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Content last updated: Monday, December 07, 2015
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