Category Archives: Gilenya

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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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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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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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Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

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Two Men Found Dead of Carbon Monoxide Poisoning

Two Men Found Dead of Carbon Monoxide Poisoning at Long Island, New York Auto Shop

Two men were found dead of apparent carbon monoxide poisoning in a Holbrook, New York, auto-detailing shop Thursday night, Suffolk County police say.

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Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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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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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

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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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