Tag Archives: Warning
First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL
The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...
Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation
A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.
Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man
A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...
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 ...
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.
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, ...
Bisphosphonate Study Confirms Atypical Thigh Fracture Risk
New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...
$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial
An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...
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 ...
Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery
An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.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
