Category Archives: Gadolinium

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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Boston Scientific Transvaginal Mesh

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.

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Study Links Liquid in E-Cigarette to Viral Infections

Study Links Liquid in Electronic Cigarette to Increased Risk of Viral Infections

The National Jewish Health study, links the liquid used in e-cigarettes to a higher risk of respiratory viral infections, whether the liquid contains nicotine or not.

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Medtronic Settles Charges Over Kickbacks To Doctors

Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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Death in Those Taking Bactrim with ACE Inhibitors or ARBs

Sudden Death in Those Taking Bactrim Along with ACE Inhibitors or ARBs

Association between sudden death in those given Bactrim while already taking renin-angiotensin system blockers angiotensin receptor blockers (ARBs), heart medications.

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Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Some heart doctors are raising concerns about a new class of heart drugs that include Pradaxa. Recently, a number of doctors interviewed by Reuters said they were hesitant to prescribe Pradaxa, as well as another blood thinner called Xarelto, because of concerns regarding the risk of stroke, serious bleeding ...

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

Three people, including a train engineer, were injured on Wednesday when a Long Island Rail Road train hit a livery cab on the tracks west of Wyandanch station, LIRR officials said. LIRR spokesman Salvatore Arena said the driver of the Lincoln Town Car was taken to Good Samaritan Hospital Medical Center ...

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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FDA Advisors Meet on Gadolinium Dyes; Find Omniscan, OptiMark and Magnevist are Most Dangerous

A panel of medical experts has found that several gadolinium contrast dyes – < "">OptiMark, Omniscan and Magnevist – appear to carry more risk of nephrogenic systemic fibrosis (NSF) than others currently on the market. The advisory panel met yesterday … Continue reading

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Restrict Some Gadolinium Contrast Dyes, FDA Panel Says

The use of some gadolinium contrast dyes should be restricted because of their association with nephrogenic systemic fibrosis (NSF), according to a recommendation just made by a Food & Drug Administration (FDA) advisory panel. Reuters is reporting that the panel … Continue reading

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Gadolinium Contrast Dyes Face FDA Advisory Panel Review Next Week

U.S. health regulators are set to review gadolinium contrast dyes this month. The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet on December 8 to review data … Continue reading

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NSF Lawsuit Claims Hospital Negligent For Using Gadolinium Contrast Dyes

St. Luke’s Hospital in Chesterfield, Mo. faces a lawsuit filed by a victim of < "">nephrogenic systemic fibrosis (NSF). The plaintiff was administered a gadolinium based contrast dye at St. Luke’s several times starting in 2005, and was diagnosed with … Continue reading

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Dialysis, Kidney Transplant Patients Face Higher Risk of NSF from Gadolinium Agents

A study of patients exposed to gadolinium contrast dyes at the Mayo Clinic has revealed that hemodialysis patients had a 77-fold higher risk of developing nephrogenic systemic fibrosis (NSF), while kidney transplant patients had a 69-fold higher risk of the … Continue reading

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OptiMARK Gadolinium Contrast Agent Label Changed Over NSF Risk

The maker of OptiMARK gadolinium contrast agent is modifying the product’s label to contraindicate its use in patients with severe kidney impairment because of its association with nephrogenic systemic fibrosis (NSF). Mallinckrodt Inc., a Covidien company, has submitted this label … Continue reading

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Magnevist, Omniscan and OptiMARK Have Highest Risk of NSF, FDA Says

Three gadolinium contrast dyes – Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan, and Covidien ‘s OptiMARK -carry a higher risk of < "">nephrogenic systemic fibrosis (NSF) than other agents on the market, according to the U.S. Food & Drug Administration (FDA). … Continue reading

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FDA Decision to Treat Omniscan, Other Gadolinium Contrast Dyes Equally Questioned

A ProPublica investigation has found that a disproportionate number of Nephrogenic Systemic Fibrosis (NSF) cases have been associated with the use of General Electric’s (GE) < "">Omniscan gadolinium contrast dye. Yet, according to the investigation, published in Business Week, the … Continue reading

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Bayer Settles Some Magnevist Gadolinium Contrast Dye Lawsuits

Bayer AG has settled some lawsuits involving its < "">gadolinium contrast dye, Magnevist. Plaintiffs in the lawsuits claimed that Magnevist had caused Nephrogenic Systemic Fibrosis (NSF), a potentially fatal condition that develops in people with pre-existing kidney disease. Gadolinium contrast … Continue reading

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Study Suggests "Potent" Link Between NSF, Gadolinium Contrast Dyes

Another study has found a strong link between the use of gadolinium contrast dyes and the development of Nephrogenic Systemic Fibrosis (NSF). According to researchers at the University of Pennsylvania in Philadelphia, patients with advanced chronic kidney disease were 27 … Continue reading

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