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MHRA announces new valproate licensing rules

In the coming months, valproate will be issued in smaller pack sizes to encourage monthly prescribing.

Valproate Alamy 2018

Source: Simon Evans / Alamy Stock Photo

The Medicines and Healthcare products Regulatory Agency has changed licensing rules for valproate medicines in an attempt to minimise birth defects. A warning symbol will be added to valproate packs by September 2018

Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on a pregnancy prevention programme (PPP), the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

The agency has changed the licence for valproate medicines, which include Epilim and Depakote as well as generic brands, in an effort to minimise the number of birth defects and persistent developmental disorders among children who were exposed to valproate in the uterus. According to the MHRA, up to 40% of babies born to mothers who used valproate are at risk of developmental disorders. Around 10% of babies are at risk of birth defects.

In the coming months, valproate will be issued in smaller pack sizes to encourage monthly prescribing.

By September 2018, a visual warning symbol will be added to valproate medicine packs. This will depict a pregnant woman in a red circle with a line through it, accompanied by warning text about the risks of valproate and information about the new regulatory measures. The MHRA is recommending that pharmacists dispense valproate in whole packs whenever possible, to ensure that patients see the warning symbol and receive the new information. If a pack is split, or if the carton does not have a symbol on it, warning labels should be added.

In the next few weeks, healthcare professionals will receive a letter detailing the new requirements, and a set of updated educational materials. The educational materials to be sent to pharmacists will include warning labels than can be stuck to packs where needed.  

Packs of valproate medicines with a detachable patient card will start to be available from December 2018.

The MHRA’s announcement, which comes into force on 24 April 2018,  follows the European Medicines Agency’s endorsement, on 23 March 2018, of enhanced regularity measures for valproate. The National Institute for Health and Care Excellence is also amending its valproate guidelines to reflect the new regulatory position.

The Royal Pharmaceutical Society (RPS) has worked with the MHRA to produce updated information leaflets for patients, which are available now from the RPS website. The Society will update its valproate guidance documentation as soon as the MHRA releases its new resources for health professionals.

“The RPS fully supports these new measures implemented today by the MHRA to ensure women understand the risks of taking sodium valproate during pregnancy,” Ash Soni, president of the RPS, said. “They must get the right information from health professionals in order to make informed choices about their health and parenting options.

“Valproate is an effective medicine and women should never suddenly stop taking it without talking to a health professional. Pharmacists are ideally placed to give information and support when providing sodium valproate and are committed to reducing harm from medicines, enabling women to make the choices that are right for them.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204721

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