Tag Archives: Warning

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DeflateGate’s Effects Impact Legal Gambling and the Economy

DeflateGate’s Effects Impact Legal Gambling and the Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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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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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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Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...

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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...

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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

A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...

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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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DeflateGate’s Effects Impact Legal Gambling & the Economy

DeflateGate’s-Effects-Impact-Legal-Gambling-and-the-Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

Read More

Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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FDA Warns of Increased Bone Fracture Risk for Diabetes Patients Taking Invokana and Invokamet

FDA Warns of Bone Fracture Risk for Diabetes Drugs

Last week, the Food and Drug Administration (FDA) issued a safety communication providing information on bone fracture risk and decreased bone density in patients taking the diabetes drugs Invokana and Invokamet (canagliflozin). The FDA has strengthened the warning for the … Continue reading

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

FDA Issues Another Warning for Type 2 Diabetes Drug

FDA Issues Another Warning for Type 2 Diabetes Drug

Late last month, the U.S. Food and Drug Administration (FDA) warned that diabetes medications such as sitagliptin, saxagliptin, linagliptin and alogliptin could lead to “severe and disabling” joint pain. The agency said in a safety announcement that this risk would … Continue reading

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

FDA Warns of Diabetes Drugs that Can Cause Disabling Joint Pain

FDA Warns of Diabetes Drug that Causes Disabling Joint Pain

On Friday, the Food and Drug Administration (FDA) warned diabetes patients that an entire class of diabetes drugs can cause severe and disabling joint pain. The drugs include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). They are all … Continue reading

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

FDA Takes Action Against Three Tobacco Companies over “Additive-Free” and “Natural” Marketing Claims

FDA Takes Action Against Three Tobacco Companies

Three tobacco companies—ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels. ITG Brands LLC makes … Continue reading

Posted in Health Concerns | Tagged , , , , |

FDA Strengthens Heart Attack and Stoke Warnings for Nonsteroidal Anti-inflammatory Drugs

FDA Strengthens Heart Attack & Stoke Warnings for NSAIDs

The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead … Continue reading

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

Cleveland Clinic Heart & Vascular Team Warns About Food Additive Consumption

Cleveland Clinic Warns About Food Additive Consumption

Many Americans spend up to 90 percent of their food budget on processed foods, which are more convenient and can be less expensive than fresh foods, but health and nutrition experts say such foods may be less healthy than fresh … Continue reading

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

Medical Scope Makers Warned in the Wake of Superbug Outbreaks

Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.” The FDA says the companies failed to adequately report problems with the devices and, in … Continue reading

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

Gastrointestinal Scope Makers Receive FDA Warning Letters

Gastrointestinal Scope Makers Receive FDA Warning Letters

The Food and Drug Administration (FDA) sent warning letters to the three makers of a specialized gastrointestinal scope that has been linked to outbreaks of superbug infections at U.S. hospitals. In the spring, the FDA conducted inspections of the manufacturing … Continue reading

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

Olympus Receives FDA Warning Letter for Failing to Notify Agency about Superbug Infections in Required Time

Olympus Receives FDA Warning to Notify about Superbug

Gastrointestinal scope maker Olympus Corp. waited three years to alert federal regulators about 16 patient superbug infections the company learned about in 2012. The Food and Drug Administration (FDA) cited that lapse in reporting and other safety-related violations in warning … Continue reading

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

FDA Failed to Warn Public of Serious Side Effect Linked to Antibiotic Levaquin

FDA Failed to Warn Public of Levaquin Side Effect

The Food and Drug Administration (FDA) failed to disclose a serious side effect associated with the family of antibiotics known as fluoroquinolones identified in a 2013 agency report. In an investigation, Cleveland television station ABC5 obtained a 2013 FDA report … Continue reading

Posted in Cipro, Defective Products, Health Concerns, Levaquin, Pharmaceuticals | Tagged , , , , |

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