Monthly Archives: April 2015

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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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British Recall of Smith & Nephew Renasys Wound Care System

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

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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J.J. Fuds, Inc. Pet Food Recalled - Listeria Contamination

J.J. Fuds, Inc. Pet Food Recalled Over Potential Listeria Contamination

J.J. Fuds, has recalled a specific lot of its J.J. Fuds Chicken Tender Chunks Pet Food over potential contamination with the dangerous, Listeria monocytogenes pathogen.

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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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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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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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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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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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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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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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$2.4 Billion Settlement Announced in Actos Bladder Cancer Cases

$2.4B Settlement Announced in Actos Bladder Cancer Cases

On Tuesday, Takeda Pharmaceuticals announced a settlement that could go as high as $2.7 billion to resolve thousands of lawsuits from patients and their families who claim the diabetes drug Actos (pioglitazone) caused their bladder cancer. The New York Times … Continue reading

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

Study Finds Artificial Sweeteners May Cause Harmful Changes to Gut Bacteria

Artificial Sweeteners May Cause Harmful Changes to Gut Bacteria

Artificial sweeteners, such as aspartame, sucralose and saccharin, are a popular option for those looking to add sweetness without the calories. They are used to flavor a wide variety of common products, from Diet Coke to toothpaste, but there are … Continue reading

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

Consent Decree Requires Medtronic to Halt Sales of Implantable Drug Pumps

Decree Requires Medtronic to Halt Sales of Implantable Pumps

Despite years of warnings from the Food and Drug Administration (FDA), Medtronic Corp. failed to correct problems with its SynchroMed infusion drug pumps, and now the Justice Department has taken legal action to halt the sale of the pumps. At … Continue reading

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

Former FDA Commissioner Says Agency Needs to Regulate E-Cigarettes

Former FDA Commissioner Says E-Cigarette Regulation Needed

The U.S. Food and Drug Administration (FDA) is facing mounting pressure to regulate e-cigarettes after the federal government recently announced that use of the devices has tripled among young people within one year. Even though the agency has had the … Continue reading

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

Boston Scientific Loses Bid to Remove Punitive Damages Claim in Pelvic Mesh Case

Boston Scientific Loses Bid to Remove Punitive Damages Claim

Boston Scientific failed in its bid to remove punitive damages claims in a pelvic mesh lawsuit this month, Mass Device reports. This case is one out of 15,000 product liability lawsuits filed over the devices, which are used to treat … Continue reading

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

Hair Analysis has been Flawed over Decades, FBI Says

Hair Analysis has been Flawed over Decades, FBI Says

The use of microscopic hair analysis as evidence against defendants was flawed for over two decades before 2000, the Justice Department and FBI admit. According to the Washington Post, the agencies admit that almost every examiner an elite FBI forensic … Continue reading

Posted in Legal News | Tagged , , , , |

Trampoline Parks: Jumpers Risk Injury

Trampoline Parks: Jumpers Risk Injury

Trampoline parks are increasingly popular places for family recreation and children’s parties, but state and federal inspections and regulations for the facilities are lacking, putting jumpers at risk for injury. Television station 13News Now (in Chesapeake, Virginia) investigated injuries at … Continue reading

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

Jeni’s Ice Cream Recalled Due to Positive Listeria Test

Jeni’s Ice Cream Recalled Due to Positive Listeria Test

Jeni’s Splendid Ice Creams of Ohio is recalling all of its frozen treats after a sample tested positive for listeria bacteria, Associated Press reports. The recall is similar to one recently issued by Blue Bell of Texas, whose ice cream … Continue reading

Posted in Food Poisoning, Legal News, Product Recalls | Tagged , , , , |

Research Organization Claims Most Food Additives Have Not Been Properly Studied for Safety

Most Food Additives Have Not Been Properly Studied for Safety

The Food and Drug Administration (FDA) mandate to protect public health includes assuring the safety of the food supply. But according to the agency’s own database, 93 percent of food additives do not have reproductive or developmental toxicity data. Many … Continue reading

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

Medtronic Claims InFuse Injury Suits Preempted by Federal Law

Medtronic Claims InFuse Injury Suits Preempted by Federal Law

In an effort to avert lawsuits filed over injuries attributed to its InFuse bone growth device, device maker, Medtronic Inc., has tried to convince courts that the federal preemption clause of the federal Food, Drug and Cosmetic Act preempts the … Continue reading

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

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