Category Archives: Depakote

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

A newly published metal-on-metal hip replacement study is reporting that the majority of failures occur early, within two years of surgery. The study, published in the journal Orthopedics, is just the latest to indicate that close follow-up of metal-on-metal hip implant patients is warranted.

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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...

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Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Some heart doctors are raising concerns about a new class of heart drugs that include Pradaxa. Recently, a number of doctors interviewed by Reuters said they were hesitant to prescribe Pradaxa, as well as another blood thinner called Xarelto, because of concerns regarding the risk of stroke, serious bleeding ...

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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Warning for Medtronic InterStim Neurostimulation Devices

Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices

Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.

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Depakote Anti-Epilepsy Medication Linked to Birth Defects

Depakote Anti-Epilepsy Medication Linked to Birth Defects

The family of a 12-year-old child has filed a lawsuit on behalf of the young girl who underwent an extremely difficult operation, along with her mother, while she was still in the womb. The highly complicated open fetal surgery took … Continue reading

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$15 Million in Damages Awarded to Child for Birth Defects Linked to Depakote

$15M Awarded to Child for Defects Linked to Depakote

This week a St. Louis jury found that a Minnesota girl’s birth defects were caused by the epilepsy medication Depakote her mother took during pregnancy and the jury awarded the child $15 million in damages. The jury returned the unanimous … Continue reading

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British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

British Health Agency Strengthens Warnings about Valproate

The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulatory agency, has issued a statement urging healthcare professionals to give women better information on the risk of birth defects when Depakote and other valproate medicines are used during pregnancy. … Continue reading

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Epilepsy Medications Tied to Additional Fetal Risks

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An emerging study has found that anti-epileptic drugs—AEDs—contain additional risks to developing fetuses to those on current drug product labeling. AEDs include the brands Tegretol, Carbatrol, Equetro, Epitol, Lomotrigine, and Depakote. The active ingredient in Depakote is valproate. The Danish … Continue reading

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Study: Reducing Valproate Dose Could Help Minimize Some, Not All, Birth Defects

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Valproate-containing epilepsy drugs have long been linked to serious adverse health effects, including risks of babies being born with birth defects. Depakote is a valproate-containing medication. For instance, while use of epilepsy medications during pregnancy has been associated with congenital … Continue reading

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Abbott Labs Accused of Racketeering in Depakote Marketing

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A federal court complaint filed in U.S. District Court in Chicago alleges that Abbott Laboratories engaged in racketeering when it marketed the epilepsy drug Depakote (divalproex) for unapproved uses. The plaintiffs—the Sidney Hillman Health Center of Rochester, New York; the … Continue reading

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Judge Rules Abbott Can be Sued for Off-label Depakote Sales

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U.S. District Judge Virginia Kendall recently upheld a shareholder derivative complaint against Abbott Laboratories for its off-label marketing of the drug Depakote. Physicians are allowed to prescribe drugs for off-label uses, but drug companies are not permitted to market drugs … Continue reading

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FDA: Migraine Medication, Depakote, May Lower IQ Scores in Children

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United States regulators are warning pregnant women who also suffer from migraine headaches that Depakote may lower a child’s IQ score by eight to 11 points. Depakote is being changed from a Category D to a Category X drug classification. … Continue reading

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FDA Warns Pregnant Women: Do Not Take Valproate Containing Migraine Prevention Drugs During Pregnancy

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The U.S. Food and Drug Administration (FDA) has issued a warning to pregnant women against using valproate sodium products, prescribed for migraine prevention, over risks to their unborn babies. Valproate products include Depacon (valproate sodium); Depakote, Depakote CP, and Depakote … Continue reading

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FDA: Seizure Drug, Potiga, Associated with Vision Loss, Blue Skin

Anti-seizure medication, Potiga, co-marketed by GlaxoSmithKline Plc and Valeant Pharmaceuticals, may lead to optical and skin problems, the U.S. Food and Drug Administration (FDA) has said. Potiga, which was developed by Valeant, may cause skin to turn blue around the … Continue reading

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