MHRA issues guidance on contraception for women taking medicines that might increase risk of birth defects

The Faculty of Sexual and Reproductive Healthcare (FSRH) has worked with the Medicines and Healthcare products Regulatory Agency (MHRA) to produce guidance on the necessary steps to avoid an unplanned pregnancy while women are taking potential teratogens that might severely affect the foetus. Guidance includes recommendations from FSRH's guidance on contraception for women using known teratogenic drugs or drugs with potential teratogenic effects published in February 2018.

Some medicines are known or suspected to have the potential to increase the risk of birth defects and development disorders (teratogenic potential) when taken during pregnancy, especially during the first trimester (up to week 12 of pregnancy), when a woman may not know she is pregnant.

The new MHRA guidance recommends that, when using any medicine with teratogenic potential, a woman should be advised of the risks and encouraged to use the most effective contraceptive method, taking into account her personal circumstances.

 Dr Diana Mansour, Vice President of the Faculty of Sexual and Reproductive Healthcare (FSRH) for Clinical Quality, said:

“Highly effective contraceptive methods include the copper intrauterine device, the levonorgestrel-releasing intrauterine system and the progestogen implant (as long as the woman is not taking a medication that may reduce the effectiveness of the implant).

"If a combined hormonal method, progestogen only pill or injection is chosen, then, due to the typical failure rates of these methods, the additional use of a barrier method such as the male condom is advised. 

"Pharmacists, General Practitioners, practice nurses and clinicians working in this field welcome this clarification which supports patient safety.”

The MHRA guidance can be found here.

The FSRH guidance on contraception for women using known teratogenic drugs or drugs with potential teratogenic effects 2018 can be found here.