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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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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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Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

E. District of Missouri denied motion to dismiss conspiracy claims. Lawsuit alleges the defendants conspired to misrepresent true dangers with use of talcum powder.

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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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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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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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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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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