Tag Archives: Warning
FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say
The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.
Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures
In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...
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.
Scientist Calls for Federal Regulations for Fracking Pollution
Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.
Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds
A newly published metal-on-metal hip replacement study is reporting that the majority of failures occur early, within two years of surgery. The study, published in the journal Orthopedics, is just the latest to indicate that close follow-up of metal-on-metal hip implant patients is warranted.
Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries
Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...
Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise
Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...
Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices
Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...
Soda Consumption Causes Early Puberty and Increases Girls’ Cancer Risk
Drinking just one-and-a-half cans of sugar-sweetened soda a day can bring on early puberty in girls and increase their breast cancer risk.
Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds
Another lawsuit has been filed over adverse Plavix side effects. The lawsuit, filed by national law firm Parker Waichman LLP, alleges that the blood thinner, Plavix (clopidogrel), caused an Oklahoma man to suffer from multiple stomach bleeds.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
