Regulator warns epilepsy drug poses risks to pregnant women
Regulatory authority has banned medicines containing sodium valproate during pregnancy unless no other treatment is available
SA’s medicines regulator has banned the use of medicines containing sodium valproate during pregnancy unless no other treatment is available, as they significantly increase the risk of severe birth defects and developmental problems.
Valproate is used for treating epilepsy and bipolar disorder, as well as migraines.
The SA Health Products Regulatory Authority (Sahpra) issued a statement on Friday saying women of child-bearing age should not be started on valproate unless no other effective treatment is available, and those already taking the drug should be made aware of the risks and take precautions to avoid falling pregnant.
The move follows similar steps taken by other regulators, such as the UK’s Medicines and Health Products Regulatory Agency, which restricted the use of sodium valpropate in April.
Sahpra said an estimated one in 10 babies exposed to valproate in utero were likely to develop serious birth defects, such as spina bifida, facial and skull deformities, and heart, kidney and limb defects. Up to 40% of babies whose mothers took valproate during pregnancy could develop developmental problems, such as delayed speech and walking. They were also at greater risk of having autism spectrum disorder and attention deficit hyperactivity disorder, said the regulator.
Medicines containing valproate sold in SA include Epilim, Epilizine, Navalpro, Eprolep, Adco Sodium Valproate, Valeptic, Sandoz Sodium Valproate, Cerepiv and Convulex.
Sahpra will from now on require women who are prescribed valproate to sign an acknowledgement of risk form indicating they are aware of the risks and the need to avoid falling pregnant. Their prescribing doctor will also have to sign the form, indicating that the patient has been properly informed of the dangers posed by valproate.