Tag Archives: unapproved

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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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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Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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Exploding Tanks Kill Jeep Drivers 18 months after Recall

Exploding Gas Tanks Continue to Kill Jeep Drivers 18 months after Recall

Chrysler recalled Jeeps with exploding gas tanks more than 18 months ago, but 1 million+ of these vehicles have not been fixed as the death toll continues to rise.

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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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.

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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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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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FDA Takes Action Against Eardrops with Unapproved Ingredients

FDA Takes Action Against Unapproved Eardrops

The Food and Drug Administration (FDA) has issued a warning to parents about prescription eardrops that contain unapproved ingredients that can lead to dangerous side effects. The unapproved prescription eardrops contain active ingredients such as benzocaine and hydrocortisone, and have … Continue reading

Posted in Benzocaine, Health Concerns, Pharmaceuticals | Tagged , , , , |

Manufacturers Must Stop Selling Unapproved Prescription Ear Drops, FDA Says

Manufacturers Must Stop Selling Unapproved Ear Drops

In a July 1st press release, the U.S. Food and Drug Administration (FDA) announced that it plans “to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve … Continue reading

Posted in Health Concerns, Legal News, Pharmaceuticals | Tagged , , , |

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