Tag Archives: no FDA approval

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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FDA Gives 7 Companies Go Ahead To Market Generic Plavix

The U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix. Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to ...

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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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Hip Replacement, Knee Implant Patients with Diabetes, Other Health Problems May Face Difficult Recoveries

Patients receiving hip replacement devices or knee implants may face a more complicated recovery if they are obese, or suffer from diabetes or other health woes. According to a new study published online in the journal Anesthesiology, at least 3% of all total hip or knee replacement patients will ...

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Two Men Found Dead of Carbon Monoxide Poisoning

Two Men Found Dead of Carbon Monoxide Poisoning at Long Island, New York Auto Shop

Two men were found dead of apparent carbon monoxide poisoning in a Holbrook, New York, auto-detailing shop Thursday night, Suffolk County police say.

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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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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation Lawsuit

A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports.

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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.

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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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FDA Warns About Difficulty of Effectively Disinfecting Duodenoscopes

FDA Warns About Difficulty of Effectively Disinfecting Duodenoscopes

The Food and Drug Administration (FDA) has issued a safety communication to raise awareness that the design of ERCP endoscopes (also called duodenoscopes) may impede effective disinfection of the reusable devices. The FDA says recent reports associate multidrug-resistant bacterial infections … Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , , , , |

FDA Never Approved Scopes Implicated in Superbug Outbreak

FDA Never Approved Scopes Implicated in Superbug Outbreak

The U.S. Food and Drug Administration (FDA) never approved the model of duodenoscope implicated in the recent superbug outbreak at Ronald Reagan UCLA Medical Center, CNN reports. Between October to January, the scopes spread the superbug carbapenem-resistant Enterobacteriaceae (CRE) to … Continue reading

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