Category Archives: Gilenya

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Zadroga Act Cancer Decision Expected This Week

The federal official tasked with determining what ailments should be covered by the federal Zadroga Act is expected to decide by Saturday if certain cancers will be eligible for compensation. The decision is being eagerly awaited by thousands of first responders who believe they developed cancer due to exposure ...

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Exploding Tanks Kill Jeep Drivers 18 months after Recall

Exploding Gas Tanks Continue to Kill Jeep Drivers 18 months after Recall

Chrysler recalled Jeeps with exploding gas tanks more than 18 months ago, but 1 million+ of these vehicles have not been fixed as the death toll continues to rise.

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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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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Sleep Aids Can Increase Alzheimer’s Risk

A new study has found that over-the-counter sleeping aids and anti-allergy medicines can increase the risk of Alzheimer’s disease.

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Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Birth Control Shot Depo-Provera may Increase HIV Risk

Birth Control Shot Depo-Provera may Increase HIV Risk, Study Suggests

A new study has linked the use of Depo-Provera (medroxyprogesterone acetate), an injectable type of birth control, to an increased risk of HIV infection.

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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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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