High-Dose Folic Acid During Pregnancy May Increase Cancer Risk for Children, When Mother Also Takes Epilepsy Drugs
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Depakote Birth Defect Risks Lead to Pregnancy Prevention Requirements in UK April 30, 2018 Irvin Jackson Add Your Comments 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.” Learn More About Depakote Lawsuits Side effects of Depakote use during pregnancy may cause birth defects, delays. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Depakote Lawsuits Side effects of Depakote use during pregnancy may cause birth defects, delays. Learn More SEE IF YOU QUALIFY FOR COMPENSATION 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. Tags: Birth Defects, Children, Depakote, Epilepsy, Epilepsy Drug, Pregnancy, Valproate More Depakote Lawsuit Stories Both Epilepsy and Anti-Seizure Drugs Increase Osteoporosis Risk, Study Warns June 15, 2023 Depakote Use During Pregnancy Linked to Psychiatric Problems in Childhood, Study Warns April 20, 2023 High-Dose Folic Acid During Pregnancy May Increase Cancer Risk for Children, When Mother Also Takes Epilepsy Drugs October 4, 2022 0 Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA TermEmailThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES New Bard Hernia Mesh Lawsuits Continue To Be Filed Following Global Settlement (Posted: today) In the six months since a Bard hernia mesh settlement agreement was reached, at least two dozen new lawsuits have been brought, as the implants continue to fail and require revision surgery. 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Depakote Use During Pregnancy Linked to Psychiatric Problems in Childhood, Study Warns April 20, 2023
High-Dose Folic Acid During Pregnancy May Increase Cancer Risk for Children, When Mother Also Takes Epilepsy Drugs October 4, 2022
New Bard Hernia Mesh Lawsuits Continue To Be Filed Following Global Settlement (Posted: today) In the six months since a Bard hernia mesh settlement agreement was reached, at least two dozen new lawsuits have been brought, as the implants continue to fail and require revision surgery. MORE ABOUT: HERNIA MESH LAWSUITHernia Surgery Malpractice Lawsuit Cleared To Move Forward Over Botched Procedure (03/21/2025)Mediation To Discuss Settling Covidien Hernia Mesh Lawsuits Set for March 31 Through April 4 (03/14/2025)Covidien Hernia Mesh Settlement Talks To Get Underway After Parties Select Mediator Next Week (02/19/2025)
Four BioZorb Breast Tissue Marker Lawsuits Selected for Bellwether Trials (Posted: yesterday) As new BioZorb lawsuits continue to be filed over complications with the recalled breast tissue markers, lawyers indicate they are on track for the first of four test cases to go before a jury in September 2025. MORE ABOUT: BIOZORB LAWSUITCourt Clears BioZorb Lawsuit Design Defect Claims Over Recalled Breast Tissue Marker (03/26/2025)Group of 7 BioZorb Injury Lawyers Appointed to Leadership Positions in Lawsuits Over Recalled Breast Tissue Marker (03/19/2025)Breast Cancer Survivors File Lawsuit Over Recalled BioZorb Tissue Marker (03/12/2025)
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