Other safety alerts
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| European Union: Updated recommendations for contraception in men and women taking mycophenolate medicines |
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The European Medicines Agency (EMA) has updated recommendations for contraception in men and women taking mycophenolate medicines which are used to prevent rejection of transplanted organs.
Mycophenolate medicines are known to increase the risk of malformations and miscarriages during pregnancy if the fetus is exposed to them in the womb.
EMA has now concluded that current evidence does not indicate a risk of malformations or miscarriages when the father has taken mycophenolate, although the risk of genotoxicity cannot be completely ruled out.
For male patients, EMA now recommends that either the male patient or his female partner use reliable contraception during mycophenolate treatment and for at least 90 days after stopping treatment.
The previous recommendation that male patients should use condoms in addition to their female partners using a highly effective method of contraception has now been removed as this does not reflect the level of risk.
For female patients, the risk is unchanged. These medicines must not be used in pregnant women unless there are no suitable alternatives to prevent transplant rejection. In addition, female patients who can become pregnant must use at least one reliable form of contraception before, during and for 6 weeks after stopping treatment. Two forms of contraception are preferred but no longer mandatory.
The updated recommendations follow a periodic review of mycophenolate medicines by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which considered the available clinical and non-clinical data. The recommendations have now been adopted by the Committee for Medicinal Products for Human Use (CHMP).
Healthcare professionals and patients are advised of the followings:
- Recommendations to manage the risk of malformations or miscarriages following treatment with mycophenolate have been updated.
- Male patients or their untreated female partner must use reliable contraception during mycophenolate treatment and for at least 90 days after stopping treatment. (It is no longer required that they both use contraception.)
- Female patients who can get pregnant must use at least one reliable form of contraception before, during and for 6 weeks after stopping treatment. Two forms of contraception are preferred but no longer mandatory.
- Patients and healthcare professionals are reminded that mycophenolate medicines must never be used in pregnant women except in those instances where there are no suitable alternatives to prevent organ rejection.
- Patients who have any questions should speak to their doctor. Patients will also receive updated educational material with advice on contraception.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002871.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 27 registered pharmaceutical products containing mycophenolate mofetil or mycophenolic acid. All products are prescription only medicines. News on teratogenic risk of mycophenolic acid related drugs was previously issued by various overseas drug regulatory authorities since October 2015, with the latest update posted in March 2017. So far, the Department of Health (DH) has received 23 cases of adverse drug reactions in connection with mycophenolic acid, and one of them was related to missed abortion after taking the drug.
In December 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 including the EMA.
In view of the above EMA’s recommendations, DH will continue to remain vigilant on any new safety update by other overseas drug regulatory authorities regarding mycophenolic acid and related drugs.
Ends/ Saturday, December 16, 2017
Issued at HKT 15:15
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