Tag Archives: loophole

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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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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 ...

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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.

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MTA Bus Crash and Two Cars Injures 23 at Utica Ave. & Clarendon Rd

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.

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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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 Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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Metal-on-Metal Hip Replacement Device

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 ...

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Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.

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64 More Plavix Patients File Suit Over Bleeding Side Effects

Another Plavix lawsuit has been filed on behalf of 64 Plavix patients who allege bleeding side effects. Plavix (clopidogrel) is a blood thinner prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, such as the heart attacks and strokes it is ...

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Regulatory Loophole Can Allow Unsafe Devices Onto Market

Data from the U.S. Food and Drug Administration (FDA) shows that there are over 100,000 medical devices on the market. Unfortunately, not all of them are safe. In fact, agency data indicates that between 13 and 75 devices are recalled … Continue reading

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