Category Archives: Gilenya
Crash Involving MTA Bus and Two Cars Injures 23
Police are investigating an accident in Brooklyn on Wednesday afternoon that injured 23 people, 3 of them critically, when a car was knocked into the path of an MTA bus.
Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit
A Louisiana man has become the latest to claim that his taking the type 2 diabetes drug Actos resulted in developing bladder cancer. He has filed a lawsuit against the Japanese manufacturer of the drug and the marketer of it in the U.S., claiming they failed to warn about this ...
Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch
Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.
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 ...
Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR
Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.
Metal-on-Metal Hip Replacement Concerns Grow in Canada
Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...
Tentative Ohio Fracking Regulations Criticized as too Lax
Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.
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.
Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries
More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.
Whistleblower Wins Retaliation Lawsuit
A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports.Health Canada Strengthens Safety Warnings for Multiple Sclerosis 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
FDA Updates Gilenya Label to Include Cases of Rare 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
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
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
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
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
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
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
