The European Medicines Agency (EMA) has issued updated recommendations for contraception in men and women taking mycophenolate medicines to prevent rejection of transplanted organs.
The immunosuppressant mycophenolate is known to increase the risk for malformations and miscarriages during pregnancy if the fetus is exposed in utero.
However, the EMA has concluded that current available evidence does not indicate a risk for malformations or miscarriages during pregnancy when the father has taken mycophenolate medicines, although the risk for genotoxicity cannot be completely ruled out.
For a male patient, the EMA now recommends that either he or his female partner 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.
“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,” the EMA said in a statement.
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 EMA advised.
The updated recommendations follow a periodic review of mycophenolate medicines by the EMA Pharmacovigilance Risk Assessment Committee, which considered all available data. The recommendations have been adopted by the EMA Committee for Medicinal Products for Human Use.
The EMA said a letter will be sent to healthcare providers in the European Union to inform them of the outcome of the review and the updated recommendations.
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