Monthly Archives: January 2007

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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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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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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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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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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Some heart doctors are raising concerns about a new class of heart drugs that include Pradaxa. Recently, a number of doctors interviewed by Reuters said they were hesitant to prescribe Pradaxa, as well as another blood thinner called Xarelto, because of concerns regarding the risk of stroke, serious bleeding ...

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Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

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New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions

Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...

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Geodon the antipsychotic drug can Cause Deadly Skin Reaction

Geodon can Cause Deadly Skin Reaction, FDA Warns

The FDA has required a new warning label for the antipsychotic drug Geodon (ziprasidone) to include the risk of a potentially fatal skin reaction.

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FDA Announces New Drug Safety Measures

In a statement issued this week, the U.S. Food and Drug Administration (FDA) announced a renewed commitment to its drug safety system. Based on recommendations from a report by the Institute of Medicine (IOM), the agency outlined a series of … Continue reading

Posted in Health Concerns, Legal News |

BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)

According to journalists at the BBC, GlaxoSmithKline intentionally distorted and covered up damaging information about their antidepressant Seroxat and its link to an increased risk of suicide in children. Researchers for the BBC documentary series Panorama obtained three critical documents … Continue reading

Posted in Health Concerns, Legal News |

Wyeth Loses Prempro Suit

Pharmaceutical giant Wyeth was ordered by a Pennsylvania state jury to pay $1.5 million in compensatory damages to an Arkansas woman and her husband who held the company’s hormone replacement therapy (HRT) drug Prempro responsible for the woman’s breast cancer. … Continue reading

Posted in Health Concerns, Legal News |

Judge Rejects State Farm Settlement

In another apparent legal blow to State Farm Fire & Causalty Co., U.S. District Judge L.T. Senter rejected a Mississippi class-action settlement related to Hurricane Katrina damage, claiming that the proposed settlement favored the needs of the insurance company over … Continue reading

Posted in Consumer Fraud, Legal News |

Amgen’s Anemia Drug Aranesp Carries Risk in Cancer Patients

In a letter sent last week to medical professionals and posted by the U.S. Food and Drug Administration (FDA), drug maker Amgen warned of an elevated risk of fatalities associated with the use of their anemia drug, Aranesp (darbepoetin alfa), … Continue reading

Posted in Health Concerns, Legal News |

Genentech Issues Warning About Eye Drug Lucentis

In a letter sent to 1,500 eye doctors, Genentech is warning that its macular degeneration drug, Lucentis, may increase the risk of stroke if administered in high doses. Approved a mere six months ago by the FDA, Lucentis has already … Continue reading

Posted in Health Concerns, Legal News |

Trasylol Clinical Trials Halted

Bayer HealthCare announced it is discontinuing three clinical trials for their drug, Trasylol, citing recent FDA-approved label changes. Bayer was hoping to expand the approved usage of the drug, which currently is only approved for use in the course of … Continue reading

Posted in Defective Products, Health Concerns, Legal News |

Study: Long-Term Cell Phone Use May Be Linked to Brain Tumors

For the past decade or more, many people have feared that excessive cell-phone usage may lead to an increased risk of developing brain tumors. Yet, that hypothesis has never been proven. A new European study, to be published in next … Continue reading

Posted in Health Concerns |

Executive Order Gives White House More Regulatory Power

Few people may have noticed, but the White House recently handed down a decree that may have significant effects on several areas of federal regulation in the United States. Last week, President George W. Bush issued new amendments to Executive … Continue reading

Posted in Health Concerns, Legal News |

FDA Backs Off New Birth-Control Guidelines

This week, the U.S. Food and Drug Administration’s Reproductive Health Drugs Advisory Committee held a two-day meeting to discuss, among other items, the possibility of implementing new standards of effectiveness for hormonal contraceptives. However, while the panel encouraged drug manufacturers … Continue reading

Posted in Health Concerns, Legal News |

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