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

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

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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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

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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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

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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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...

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FDA Gives 7 Companies Go Ahead To Market Generic Plavix

FDA Gives 7 Companies Go Ahead To Market Generic Plavix

The U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix. Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to ...

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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FDA Reviews Heart Failure Risks Associated with Diabetes Drugs Onglyza and Kombiglyze

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In a Drug Safety Communication issued Tuesday, the U.S. Food and Drug Administration (FDA) said that it has requested clinical trial data to analyze the association between heart failure and saxagliptin, a Type 2 diabetes drug marketed as Onglyza and … Continue reading

Posted in Legal News |

Despite Increasing Injury Reports, Mounting Lawsuits, and Growing Data, FDA, EMA Will Not Confirm Increased Pancreatic Side Effects with Incretin Drugs

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The U.S. Food and Drug Administration (FDA) agrees with the European Medicines Agency (EMA) that prevailing data concerning Type 2 diabetes medications in the class known as glucagonlike peptide-1 (GLP-1)-based diabetes therapies, do not confirm increased pancreatic side effect risks, … Continue reading

Posted in Byetta Cancer, Pharmaceuticals |

Glaxo Agrees to $229 Million Avandia Settlement with Eight States

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In response to lawsuits brought by eight U.S. states, drug maker, GlaxoSmithKline, has agreed to pay hundreds of millions of dollars to settle actions over diabetes medication, Avandia (rosiglitazone). The drug maker announced it would pay $229 million and, in … Continue reading

Posted in Avandia, Pharmaceuticals |

Texas Man Files Lawsuit Alleging Actos Caused His Bladder Cancer

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A Texas man has filed a lawsuit in the U.S. District Court for the Western District of Louisiana (Case No. 6:13-cv-02229) alleging that the diabetes drug Actos is to blame for his bladder cancer. This case is one of thousands … Continue reading

Posted in Actos, Health Concerns, Pharmaceuticals |

Drug Maker, Roche, Ceases New Type 2 Diabetes Drug Testing Over Safety Risks

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Drug maker, Roche, just announced it has stopped development of a diabetes drug that is in the same class as the Type 2 diabetes drugs Actos and Avandia. The move, according to The New York Times, could raise safety concerns … Continue reading

Posted in Actos, Avandia, Pharmaceuticals |

Diabetes Drug Fails to Cut Heart Risks, Clinical Trial Shows

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In a large clinical trial, Onglyza (saxagliptin), a Type 2 diabetes medication, failed to reduce the risk of heart attacks and related disease compared with a placebo. But the drug, co-marketed by Bristol-Myers Squibb and AstraZeneca, did not increase cardiovascular … Continue reading

Posted in Avandia, Health Concerns, Pharmaceuticals |

Type 2 Diabetes Medication Risks Examined in Journal Review

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Incretin mimetics, a class of Type 2 diabetes drugs, are sparking debate and renewing concerns about health risks, especially to the pancreas. In fact, a piece published in the journal BMJ, states that the drugs, which include Byetta and Januvia, … Continue reading

Posted in Byetta Cancer, Pharmaceuticals |

New Lawsuit Alleges Actos Caused Arizona Man’s Bladder Cancer

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An Arizona man who took the diabetes drug Actos (pioglitazone) for several years has filed a lawsuit alleging that the drug caused his bladder cancer. The lawsuit further alleges that Takeda Pharmaceuticals, the drug’s manufacturer, was aware of the risk … Continue reading

Posted in Actos, Health Concerns, Pharmaceuticals |

FDA Recommends Easing Avandia Restrictions

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A vote at the conclusion of a two-day meeting of United States health advisors ended with a recommendation to ease current market restrictions on Type 2 diabetes drug, Avandia, which is marketed by GlaxoSmithKline. The U.S. Food and Drug Administration … Continue reading

Posted in Avandia, Legal News, Pharmaceuticals |

FDA Reconsidering its Stance on Avandia

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In an unprecedented move, the U.S. Food and Drug Administration is reopening the matter involving Type 2 diabetes drug, Avandia, which is marketed by GlaxoSmithKline. Avandia belongs to a class of diabetes drugs called thiazolidinediones that lower blood sugar by … Continue reading

Posted in Avandia, Pharmaceuticals |

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