PARIS (Reuters) - More than three decades after links emerged between Sanofi’s epilepsy drug valproate and birth defects, many pregnant women remain unaware of the risks, patients, doctors and researchers said on Tuesday.
Prescribed globally for epilepsy and bipolar disorders - and in some cases migraines - valproate is included in the World’s Health Organisation list of essential medicines.
But the drug is also known to have caused birth malfunctions and slow neurological development after being taken during pregnancy.
“Measures have been taken ... but these have largely been tick-box exercises with little regard for delivering real change,” Karen Keely, from Irish patient support group Fetal Anti-Convulsant Syndrome, told a public hearing in London hosted by the European Medicines Agency (EMA).
Tuesday’s hearing was the first time the EMA has held such an event, inviting EU citizens to share their experience with a particular medication.
Sanofi, which told the hearing there was clear data showing an increased risk of malformation when taking valproate during pregnancy, said it had always provided up-to-date advice.
But parents of those affected have repeatedly said health authorities worldwide as well as the French drugmaker were too slow to warn of the drug’s side effects. It is sold under brands such as Depakote and Epilim.
At the hearing, patients, medics and researchers said there were shortcomings all along the chain from the pharmaceutical provider to the patient, including healthcare authorities.
Valproate is also at the center of a health scandal in France, where parliament voted last year to create a compensation fund for claims relating to Depakine, the brand under which valproate was first approved in 1967.
Restrictions and warnings about valproate have been strengthened across Europe during the last three years after a first review. But recent surveys in the United Kingdom showed almost 70 percent of women taking the drug had not received adequate advice.
Clare Pelham, speaking on behalf of Britain’s Epilepsy Society, said warnings on medicine packages and leaflets were insufficient and that patients needed “tailored conversations” with healthcare professionals.
Others called for public information campaigns as well as a Europe-wide census of patients on valproate.
Eric Teo, who is in charge of drug safety at Sanofi, said his company had always provided the most up-to-date scientific information with the approval of the authorities.
“Valproate is an important treatment that many women continue to rely on ... It should be acknowledged that there is a real dilemma faced by doctors and women who have no other alternatives to control their seizures.”
The EMA launched a new review of valproate safety in March at the request of the French medicines regulator ANSM.
The process, which will incorporate the input of Tuesday’s hearing, is being conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). A final recommendation is expected in December.
National authorities typically follow the advice of the EMA but the agency has no legal power to enforce particular actions on authorized medications. Valproate medicines, for which Sanofi lost its patent in 1998, are prescribed in over 100 countries.
Editing by Richard Lough and David Clarke