Category Archives: Gilenya

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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New York City Council Calls for Zadroga Act to be Renewed

New York City Council Calls for Zadroga Act to be Renewed

New York City Council members are calling for the Zadroga Act, which provides compensation and medical treatment to 9/11 victims, to be renewed. According to press release issued Jan. 7, a resolution was introduced by Council Member Margaret Chin, Council Speaker Melissa Mark-Viverito and Council Members Paul Vallone and I. ...

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability

A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.

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64 More Plavix Patients File Suit Over Bleeding Side Effects

Another Plavix lawsuit has been filed on behalf of 64 Plavix patients who allege bleeding side effects. Plavix (clopidogrel) is a blood thinner prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, such as the heart attacks and strokes it is ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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DeflateGate’s Effects Impact Legal Gambling & the Economy

DeflateGate’s-Effects-Impact-Legal-Gambling-and-the-Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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Health Canada Strengthens Safety Warnings for Multiple Sclerosis Drug Gilenya

Health Canada Strengthens Safety Warnings for Drug Gilenya

Health Canada, Canada’s health regulatory agency, has updated the label information for the multiple sclerosis drug Gilenya (fingolimod) to include stronger safety warnings on the risk of skin cancer and the rare brain infection progressive multifocal leukoencephalopathy (PML), which can … Continue reading

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FDA Updates Gilenya Label to Include Cases of Rare Brain Infection

FDA Updates Gilenya Label to Include Cases of Brain Infection

In a Drug Safety Communication issued Tuesday, the U.S. Food and Drug Administration warned that the multiple sclerosis drug Gilenya was linked to two cases of rare brain infection. One definite case of progressive multifocal leukoencephalopathy (PML) and one probable … Continue reading

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U.K. Regulator Warns Against Gilenya For Heart Patients

U.K. regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), just issued a warning against Gilenya (fingolimod) use in heart patients. The MHRA also called for extended early monitoring for patients diagnosed with significant bradycardia or heart block after the … Continue reading

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FDA Announces New Gilenya Restrictions for Heart Patients

U.S. health regulators have issued new restrictions for Gilenya, Novartis AG’s’ pill for treating multiple sclerosis. According to a Drug Safety Communication issued by the Food & Drug Administration (FDA) yesterday, Gilenya is now contraindicated (FDA advises against its use) … Continue reading

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Gilenya to Bear New Label Warnings Following Patient Deaths, Safety Reviews

Novartis has announced that it is modifying the label for Gilenya, its oral multiple sclerosis medication, following safety reviews in the U.S. and Europe. Both the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) launched Gilenya … Continue reading

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Gilenya Patient Stricken with PML Brain Infection

Novartis AG announced on Friday that a patient taking its Gilenya pill for multiple sclerosis had developed a serious, life-threatening brain infection called progressive multifocal leukoencephalopathy, or PML. According The Wall Street Journal, the report will likely raise more questions … Continue reading

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Doctors Back Off Gilenya Amid Safety Woes

Doctors are backing off prescribing multiple sclerosis (MS) medication, Gilenya (gingolimod) amid a number of safety woes. Gilenya is manufactured by Novartis AG and received U.S. regulatory approval September 2010. As we reported previously, Gilenya, the first approved MS pill, … Continue reading

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MS Drug Gilenya Under Review in Europe, but Still Deemed Safe by FDA

US medical professionals are continuing to back Novartis’ Gilenya (fingolimod) despite the growing concern following several cases of patient death in the past few months. To investigate the effects of Gilenya on one’s cardiovascular health, the European Medicines Agency (EMA) … Continue reading

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