Other safety alerts
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| The United Kingdom: Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic. The available clinical evidence does not indicate an increased risk of malformations or miscarriage in pregnancies where the father was taking mycophenolate medicines, but there is insufficient evidence to rule out any risk. As a precautionary measure for male patients, it is now recommended that either the patient or their female partner use reliable contraception during treatment with mycophenolate medicines and for at least 90 days after stopping. Female patients of childbearing potential receiving mycophenolate should always use contraception.
Mycophenolate (mycophenolate mofetil and mycophenolic acid), authorised to prevent transplant rejection, is a major human teratogen known to cause miscarriages and congenital malformation in pregnant women. Between 45% and 49% of cases of exposure to mycophenolate in pregnancy result in miscarriage, and between 23% and 27% result in malformations (see below for reminder of pregnancy-prevention advice for female patients). Mycophenolate medicines are also genotoxic. Mycophenolate medicines are excreted in the semen, raising concerns regarding pregnancies exposed via the father. In Dec 2015, based on a review of evidence at the time, MHRA advised that men receiving treatment and their female partners should both use contraception to prevent pregnancy.
Following an in-depth routine review in Europe of all the available non-clinical and clinical data for men fathering children while receiving mycophenolate mofetil and mycophenolic acid, recommendations to prevent pregnancy have been updated.
Although the amount of mycophenolate present in semen has not been determined precisely, calculations based on animal data show that the maximum amount of mycophenolate that could be transferred to a woman is low and is unlikely to have any teratogenic effect. However, mycophenolate has also been shown to be genotoxic in animal studies, albeit at concentrations higher than the human therapeutic exposure levels, and the risk of genotoxic effects on sperm cells cannot be completely excluded. The available clinical evidence, while reassuring, is currently insufficient to rule out any risk in humans.
It is therefore recommended that, as a precautionary measure, either male patients or their female partners use reliable contraception and that men planning to have children discuss this with their doctor. The previous recommendation for men receiving treatment, specifying both the male patient and their partner use contraception, is no longer considered necessary. The clinical situation is continually monitored and, as more data becomes available, advice may be updated.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/mycophenolate-mofetil-mycophenolic-acid-updated-contraception-advice-for-male-patients
In Hong Kong, there are 28 registered pharmaceutical products containing mycophenolate mofetil or mycophenolic acid. All products are prescription-only medicines. Related news was previously issued by various overseas drug regulatory authorities since 24 Oct 2015, with the latest update posted on 16 Dec 2017. So far, the Department of Health (DH) has received 25 cases of adverse drug reactions in connection with mycophenolic acid, and one of them was related to missed abortion after taking the drug.
In Dec 2016, the Registration Committee of the Pharmacy and Poisons Board discussed the teratogenic risk of mycophenolic acid and related drugs, and decided that the sales pack and/or package insert of the products should be updated to include the relevant safety information on teratogenic risk and pregnancy prevention advice endorsed by other overseas drug regulatory authorities. DH will continue to remain vigilant on any new safety update by other overseas drug regulatory authorities regarding mycophenolic acid and related drugs.
Ends/Wednesday, Feb 7, 2018
Issued at HKT 16:00
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