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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

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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Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

A newly published metal-on-metal hip replacement study is reporting that the majority of failures occur early, within two years of surgery. The study, published in the journal Orthopedics, is just the latest to indicate that close follow-up of metal-on-metal hip implant patients is warranted.

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Actos, Avandia May Up Risk for Diabetic Macular Edema

Actos, Avandia May Up Risk for Diabetic Macular Edema

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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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

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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Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent

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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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

81-year-old Port Jefferson Station man was killed in a crash at 4:57 a.m.. He lost control of the vehicle traveling west on Northern State Pkwy, on exit 42, Dix Hills.

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Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Brain Tumor


A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

Hormonal contraceptives, which contain female sex hormones, are commonly prescribed in pill form. “The Pill” first became widely available in the 1960s and gave women all over the world control over childbearing. The new study, which appeared in the British Journal of Clinical Pharmacology, reports that taking a hormonal contraceptive for at least five years is associated with a possible increase in the woman’s risk of developing a rare tumor, glioma of the brain, Science 2.0 reports.   Continue reading

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

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate


The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulatory agency, has issued a statement urging healthcare professionals to give women better information on the risk of birth defects when Depakote and other valproate medicines are used during pregnancy. These medications are used to treat epilepsy and bipolar disorder.

Following a European review last year, which found that up to 40 percent of children born to women who take valproate during pregnancy may have developmental disorders and other birth defects, MHRA moved to strengthen product information. The agency is making informational booklets available to healthcare professionals and patients and the leaflet in the drug packing is being updated with stronger warnings about the risk of developmental disorders in children exposed to valproate during pregnancy. The review found that of 35,000 women prescribed valproate, 375 become pregnant per year while taking it. Continue reading

Posted in Birth Defects, Depakote, Health Concerns, Pharmaceuticals | Tagged , , , , , |

Whistleblower Wins Retaliation Lawsuit

Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation – Canaveral National Seashore


A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports. The former employee filed a suit in 2011 alleging misconduct, including contracting violations and nepotism. Continue reading

Posted in Legal News | Tagged , , , , |

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System


The British Medicines and Healthcare Products Regulatory Agency (MHRA) has announced the recall of Smith & Nephew Renasys negative pressure wound care devices because of the risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds if there is a blockage in the vacuum system of the affected devices.

A negative pressure wound therapy (NPWT) device is an electric pump system that applies a vacuum to chronic, deep cavity wounds. The systems use disposable components such as foam or gauze dressings and tubing. If a blockage in the system is not detected, fluid from the wound can build up and leak from the dressing, according to the MHRA. The affected devices may not detect blockages and the alarm will not sound even if the dressing has visibly lifted from the wound. Continue reading

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

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA Warning for Bone Graft Products in Patients Under 18

FDA Warning – Bone Graft Products/Patients Under 18


The Food and Drug Administration has issued a safety alert to healthcare providers, patients, and parents and guardians that bone graft devices containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18.

Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to a carrier and then surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone. The FDA has approved devices such as Medtronic Infuse for orthopedic and dental use only in patients over the age of 18 who are done growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated their safety and effectiveness in patients under age 18, who are considered skeletally immature. Any product that affects bone growth has the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates. Continue reading

Posted in Defective Medical Devices, Medtonic Infuse | Tagged , , , , |

What Action Will the FDA Take on E-cigarettes?

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.

E-cigarettes, battery-powered devices that heat nicotine liquid into an inhalable vapor, have been touted as a means to wean smokers from traditional cigarettes. They do not produce smoke, and there is no carcinogenic tar produced in burning tobacco in traditional cigarettes. But smokers are not adopting the devices in the numbers expected, The New York Times reports, and some experts argue that e-cigarette manufacturers see them not as a cessation device but as a way to introduce nonsmokers, in particular young people, to smoking. Continue reading

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

Two Leading Cancer Groups Issue Call for Regulation of E-cigarettes and Research on Health Risks

Cancer Groups Call for E-cigarettes Regulation/Research

Cancer Groups Call for E-cigarettes Regulation/Research


In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects.

These leading research and treatment organizations asked the Food and Drug Administration (FDA) to make final proposed regulations for “electronic nicotine delivery systems.” Peter Paul Yu, president of the 35,000-member oncology society, said the groups’ members “are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop nicotine addiction,” the journal Science reports. The cancer research society, with 33,000 members, expressed the need for research into the health effects of e-cigarettes. Manufacturers claim that e-cigarettes help reduce smoking rates and are safe, but, Yu said, “we will not know for sure until these products are researched and regulated.” Continue reading

Posted in Arcadia Ohio Norfolk Southern Train Derailment, Health Concerns, Toxic Substances | Tagged , , , , |

Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud


Two former executives of the health technology firm NantHealth claim in a recently filed lawsuit that the company made fraudulent claims about the reliability of its system, which links patient information gathered by medical devices.

The executives also allege that NantHealth, which is owned by a billionaire doctor, may have used donations to attract federal funds so a hospital could buy its products. The wrongful termination lawsuit was filed in federal court in Panama City, Florida, last week, The New York Times reports. NantHealth counters that the former employees had demanded $2 million to prevent them from spreading false information about the company. Continue reading

Posted in Legal News | Tagged , , , , , |

Dozens Receive Nonsterile Simulated Saline Solution

Dozens Receive Nonsterile Simulated Saline Solution

Dozens Receive Nonsterile Simulated Saline Solution


The U.S. Food and Drug Administration  (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.

Some patients were hospitalized and at least one death has been linked to use of  the product, made by Wallcur LLC, Law360 reports. Wallcur began shipping the simulated saline IV bags in May 2014, the company said. Patients who received the simulated IV saline almost immediately experienced symptoms such as fever and headache, which were recognized and treated promptly in most cases, according to the FDA. Continue reading

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

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups for Regulation of E-cigarettes


The American Society of Clinical Oncology and the American Association for Cancer Research are calling on the government to regulate “electronic nicotine delivery systems” – e-cigarettes – and step up research on their health effects.

In a joint statement, the organizations expressed the urgent need for new research into the health effects of e-cigarettes, the journal Science reports. Peter Paul Yu, president of the 35,000-member oncology society, said, “While e-cigarettes may reduce smoking rates and attendant adverse health risks, we will not know for sure until these products are researched and regulated.” Yu said the researchers and health professionals are “concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop nicotine addiction.” Continue reading

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

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