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Health regulators in the United Kingdom have placed new restrictions on the use of Depakote and similar epilepsy drugs, declaring that valproate-based medications can only be prescribed to women of child-bearing age if they are part of a pregnancy prevention program.
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release on April 24, announcing new rules on how a class of medications that use the active ingredient valproate must be prescribed, due to the risk of birth defects with Depakote use by pregnant women.
“Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP),” the agency announced. “Healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the PPP. This includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.”
Depakote (valproate) and its generic equivalents are prescribed for treatment of seizures and bipolar disorder, as well as migrain headaches, but the medications have been linked to a number of serious health concerns for unborn children when used during pregnancy.
According to the MHRA, up to 40% of babies born to mothers who take Depakote are at risk of developmental disorders, and 10% are at risk of birth defects.
In addition to restricting prescriptions to women in the pregnancy prevention program, the MHRA also says that additional regulatory changes are coming that will include smaller package sizes to encourage monthly prescribing and a pictogram, or warning image, on the drugs’ labels.
The MHRA is sending out a letter to healthcare professionals in coming weeks to outline and explain the new requirements, and the National Institute for Health and Care Excellence (NICE), the U.K.’s main healthcare agency, is also changing its guidelines on the use of Depakote to mirror those by the MHRA.
In the United States, the FDA added a “black box” warning about the potential Depakote pregnancy side effects in 2006, after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.
In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women using it to treat epilepsy. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.
Abbott Laboratories and AbbVie, a subsidiary it spun off, have faced hundreds of Depakote birth defect lawsuits in state and federal courts nationwide, involving claims by families of children facing life-lifelong health complications. Plaintiffs allege that the company should be held liable for failing to warn women and the medical community about the risks associated with using the medication during pregnancy.
Before the drug’s patent expired in 2007, Depakote was a blockbuster drug generating about $1.5 billion in annual sales for AbbVie’s predecessor.