Tag Archives: Food and Drug Administration

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Warning for Medtronic InterStim Neurostimulation Devices

Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices

Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.

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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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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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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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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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Research Study Confirms Fracking Cause of Ohio Earthquakes

Research Study Confirms Fracking as Cause of Ohio Earthquakes

Fracking operation near Poland Township, Ohio, activated a previously unknown fault in the, causing 77 earthquakes with magnitudes ranging from 1.0 to 3.0 in March 2014.

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Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent

Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer. This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Fracking Should be Kept 600m From Aquifers, Study Says

New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...

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FDA Investigation Finds Underreporting of Medical Device Problems

FDA Finds Underreporting of Medical Device Problems

Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA), but an FDA investigation has revealed that many hospitals are likely underreporting these events. This reporting helps the FDA identify … Continue reading

Posted in Defective Medical Devices, Duodenoscope | Tagged , , , , |

Teleflex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Use

Teleflex Medical Recalls Tracheostomy Tube Set

Teleflex Medical has issued a recall for the Willy Rusch Tracheostomy Tube Set because the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, the … Continue reading

Posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices | Tagged , , , , |

Federal Regulators Issue Warning Letter to Teva Pharmaceuticals

Federal Regulators Issue Warning to Teva Pharmaceuticals

Teva Pharmaceuticals just received a “Warning Letter” from the U.S. Food and Drug Administration (FDA) due to the agency’s Current Good Manufacturing Practices (CGMP) inspection of Teva’s Gödöllő, Hungary’s manufacturing facility. Teva was also placed on Import Alert 66-40 on … Continue reading

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

Premature Battery Depletion of Defibrillator Caused Two Deaths

Premature Battery Depletion of Defibrillator Caused 2 Deaths

On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D … Continue reading

Posted in Defective Medical Devices, Health Concerns, St. Jude Defibrillators | Tagged , , , , |

Fresh Express American Salad Voluntarily Recalled

Fresh Express American Salad Voluntarily Recalled

A voluntary precautionary recall has been issued by Fresh Express Incorporated of 480 cases of 11-oz. Fresh Express American Salad with a Product Code of G264A12A and a Use-by-Date of October 5, 2016. The reason for the removal of the … Continue reading

Posted in Food Products, Health Concerns, Product Recalls, Recalled Food Products | Tagged , , , , |

Hepatitis B Reactivation in Certain Patients Taking Hepatitis C Drugs

epatitis B Reactivation in Patients Using Hepatitis C Drugs

The U.S. Food and Drug Administration (FDA) has mandated that its most serious warning, the so-called “black box,” be placed on nine brand name hepatitis C virus (HCV) drugs. The call for the black box followed 24 reported cases of … Continue reading

Posted in Pharmaceuticals | Tagged , , , , |

GAO Says FDA Information Systems Riddled with Cybersecurity Flaws

GAO Says FDA Info. Systems Riddled with Cybersecurity Flaws

The Government Accountability Office (GAO) has found that the U.S. Food and Drug Administration’s (FDA) online information system has a number of weaknesses that make it vulnerable to cyberattacks. After conducting a review, GAO said it found over 80 weaknesses … Continue reading

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

DePuy Pinnacle MDL Status Update: Jury Selected, Motion to Quash Denied

DePuy Pinnacle Update: Jury Selected, Motion to Quash Denied

A jury was selected last week in a case in the DePuy Pinnacle multidistrict litigation (MDL). The MDL—IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation—(MDL 2244) is being heard in the Northern District Court, Northern District of … Continue reading

Posted in Defective Medical Devices, Depuy | Tagged , , , , |

Final Rule for Antibacterial Soap Efficacy and Safety Released by Federal Regulators

Final Rule for Antibacterial Soap Efficacy and Safety

Officials with the U.S. Food and Drug Administration (FDA) just released the agency’s final rule concerning over-the-counter (OTC) consumer antiseptic hand soap products that are made with specific active ingredients, including triclocarban and triclosan. These soaps are no longer marketable … Continue reading

Posted in Health Concerns, Toxic Substances | Tagged , , , , , , , |

In Xarelto MDL, Judge Extends Deadline to File Complaints

In Xarelto MDL, Judge Extends Deadline to File Complaints

Certain groups of plaintiffs in the Xarelto multidistrict litigation (MDL) have more time to file a lawsuit against manufacturers Janssen Pharmaceuticals and Bayer Healthcare. According to a recent order issued by Judge Eldon Fallon, who is overseeing the MDL in … Continue reading

Posted in Pharmaceuticals | Tagged , , , , , , , |

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