Daily Archives: June 26, 2005
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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, ...
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 ...
FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety
An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...
Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions
Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...
Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting
An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...
New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability
A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.
Canadian Study Confirms Actos Bladder Cancer Risk
A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...
Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke
The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...
Do Vitamin Drinks Pose Health Risks?
Scientists are concerned vitamin drinks are contributing to levels of vitamins and other nutrients that are not only unnecessary, but potentially harmful.DISTURBING STUDY FINDS VIOLENT VIDEO GAMES TRIGGER THE SAME BRAIN RESPONSES AS THOSE OBSERVED DURING ACTS OF REAL AGGRESSION AND WHILE IMAGINING VIOLENT BEHAVIOR
For years the evidence has been mounting that children and adolescents with aggressive tendencies are susceptible to the increasingly violent images in video games and on television. Less than two weeks ago a new study even suggested that these extremely … Continue reading
Posted in Legal News
BRAZIL THREATENS TO BREAK PATENT ON ANTI-AIDS DRUG UNLESS ABBOTT LABORATORIES LOWERS THE PRICE TO MAKE IT AFFORDABLE
At a time when drug prices are soaring to the point where the average person can no longer afford them, the Brazilian government is actually threatening to do something about it.Brazilian Health Minister Humberto Costa has announced that the price … Continue reading
Posted in Legal News
THE CONSUMER PRODUCT SAFETY COMMISSION (CPSC) AND TARGET CORP. ANNOUNCE RECALL OF 230,000 ìBIRCH AND BARK CANDLESî FOR FIRE AND BURN HAZARD
The CPSC, in cooperation with Target Corp. of Minneapolis, Minnesota, has announced a voluntary recall of 230,000 Birch and Bark Candles manufactured in China. Consumers should stop using the recalled product immediately.The birch and bark surrounding the candles can ignite, … Continue reading
Posted in Defective Products
