Tag Archives: Warning
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 ...
Former Executives Accuse Health Technology Firm of Fraud
Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.
Pennsylvania Health System Proposes Comprehensive Fracking Study
A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.
FDA Urged to Ban Powdered Caffeine
Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.
New York Property Owners Challenge Binghamton Fracking Ban
According to a Reuters report, the landowners believe the Binghamton, N.Y., city council and Mayor acted against proper protocol when voting to ban fracking drilling the the city. Instead, they feel the city should have consulted with the Broome County Planning Commission before approving the ban.
FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety
An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...
Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting
An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...
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.
Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions
Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...
Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss
E. District of Missouri denied motion to dismiss conspiracy claims. Lawsuit alleges the defendants conspired to misrepresent true dangers with use of talcum powder.FDA Warns of Increased Bone Fracture Risk for Diabetes Patients Taking Invokana and Invokamet
Last week, the Food and Drug Administration (FDA) issued a safety communication providing information on bone fracture risk and decreased bone density in patients taking the diabetes drugs Invokana and Invokamet (canagliflozin). The FDA has strengthened the warning for the … Continue reading
FDA Issues Another Warning for Type 2 Diabetes Drug
Late last month, the U.S. Food and Drug Administration (FDA) warned that diabetes medications such as sitagliptin, saxagliptin, linagliptin and alogliptin could lead to “severe and disabling” joint pain. The agency said in a safety announcement that this risk would … Continue reading
FDA Warns of Diabetes Drugs that Can Cause Disabling Joint Pain
On Friday, the Food and Drug Administration (FDA) warned diabetes patients that an entire class of diabetes drugs can cause severe and disabling joint pain. The drugs include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). They are all … Continue reading
FDA Takes Action Against Three Tobacco Companies over “Additive-Free” and “Natural” Marketing Claims
Three tobacco companies—ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels. ITG Brands LLC makes … Continue reading
FDA Strengthens Heart Attack and Stoke Warnings for Nonsteroidal Anti-inflammatory Drugs
The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead … Continue reading
Cleveland Clinic Heart & Vascular Team Warns About Food Additive Consumption
Many Americans spend up to 90 percent of their food budget on processed foods, which are more convenient and can be less expensive than fresh foods, but health and nutrition experts say such foods may be less healthy than fresh … Continue reading
Medical Scope Makers Warned in the Wake of Superbug Outbreaks
Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.” The FDA says the companies failed to adequately report problems with the devices and, in … Continue reading
Gastrointestinal Scope Makers Receive FDA Warning Letters
The Food and Drug Administration (FDA) sent warning letters to the three makers of a specialized gastrointestinal scope that has been linked to outbreaks of superbug infections at U.S. hospitals. In the spring, the FDA conducted inspections of the manufacturing … Continue reading
Olympus Receives FDA Warning Letter for Failing to Notify Agency about Superbug Infections in Required Time
Gastrointestinal scope maker Olympus Corp. waited three years to alert federal regulators about 16 patient superbug infections the company learned about in 2012. The Food and Drug Administration (FDA) cited that lapse in reporting and other safety-related violations in warning … Continue reading
FDA Failed to Warn Public of Serious Side Effect Linked to Antibiotic Levaquin
The Food and Drug Administration (FDA) failed to disclose a serious side effect associated with the family of antibiotics known as fluoroquinolones identified in a 2013 agency report. In an investigation, Cleveland television station ABC5 obtained a 2013 FDA report … Continue reading
