Monthly Archives: June 2015

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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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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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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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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...

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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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E-cigarettes Could Increase Risk of Lung Infections

E-cigarettes Could Increase Risk of Lung Infections

New research suggests the liquid used in electronic cigarettes could increase the risk of viral lung infections, regardless of whether it contains nicotine.

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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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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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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Advocacy Groups Sue for Release of Clinical Trial Data for Hepatitis C Drugs

Advocacy Groups Sue for Release of Clinical Trial Data

Two public health advocacy organizations have filed a lawsuit against the Food and Drug Administration (FDA) for release of clinical trial data for Gilead Sciences hepatitis C treatments. Researchers and patient advocates have long fought with drug makers and regulators … Continue reading

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

Study Shows Energy Drinks Can Lead to Caffeine Intoxication

The fact that energy drinks contain excessive amounts of caffeine comes as no surprise. But what are the chances that these popular beverages present real health risks? A study published in the journal Drug and Alcohol Dependence investigated this; the … Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , , |

ADHD Treatment May Cause Permanent Skin Discoloration, FDA Warns

ADHD Treatment May Cause Permanent Skin Discoloration

The Daytrana patch, a daily treatment for attention deficit hyperactivity disorder (ADHD), may cause permanent skin color changes, the Food and Drug Administration (FDA) warns. The FDA added a new warning to the drug label to describe this skin condition, … Continue reading

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

UK Regulators Issue Updated Guidance for Smith & Nephew Metal-on-Metal Hip Implants

UK Regulators Issue Updated for Smith & Nephew Hip Implants

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has issued updated guidance for Smith & Nephew Orthopaedics Birmingham Hip Resurfacing (BHR) system due to a higher than expected failure rate. According to a medical device alert posted on the … Continue reading

Posted in Defective Medical Devices, Legal News, Product Recalls | Tagged , , , |

Thousands of Complaints Prompt FDA Panel Meeting about Essure Birth Control

Complaints Prompt FDA Panel Meeting about Essure

In response to more than 5,000 reports of adverse events and side effects of the Essure birth control implant, the Food and Drug Administration (FDA) has scheduled a hearing for September 24 to evaluate the safety and effectiveness device. The … Continue reading

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

FDA Says Partially Hydrogenated Oils, Source of Trans Fat, Must be Removed from Food

FDA Says Hydrogenated Oils Must be Removed from Food

In a press release issued last Tuesday, the U.S. Food and Drug Administration (FDA) announced that partially hydrogenated oils (PHO), the main source of trans fat in processed foods, must be removed from food products over the next three years. … Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , |

Medtronic Recalls Tracheostomy Tubes Because of Injury Reports

Medtronic Recalls Tracheostomy Tubes Because of Reports

Medtronic PLC has announced the voluntary recall of 70,000 tracheostomy tubes for children and babies following reports that some patients have had difficulty breathing while using them. Hundreds of adverse events involving the Covidien Shiley tube have been reported to … Continue reading

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

Covidien Agrees to Settlement in 11,000 Transvaginal Mesh Cases

Covidien to Settlement in 11,000 Transvaginal Mesh Cases

Device maker Covidien has agreed to a settlement of more than 11,000 claims involving its transvaginal mesh devices, alleged to have caused severe and painful side effects. A court filing on Tuesday in West Virginia federal court did not disclose … Continue reading

Posted in Defective Medical Devices, Transvaginal mesh | Tagged , , , |

Research Indicates Viagra Use Could Increase Melanoma Risk by 20 Percent

Viagra Use Could Increase Melanoma Risk by 20 Percent

A new research study shows that men who use Viagra and similar drugs to treat erectile dysfunction could be at greater risk of developing skin cancer. The study, published this week in the Journal of the American Medical Association, looked … Continue reading

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Study Indicates Popular Sleep Medications Increase Risk of Respiratory Cancers

Sleep Medications Increase Risk of Respiratory Cancers

A new research study reveals that some of the most widely used sleep medications could triple the user’s risk of lung cancer. The widely used medications—benzodiazepines and “Z-hypnotic” drugs—are carcinogenic, the (U.K.) Daily Mail reports. Taking these drugs on a … Continue reading

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