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Death in Those Taking Bactrim with ACE Inhibitors or ARBs

Sudden Death in Those Taking Bactrim Along with ACE Inhibitors or ARBs

Association between sudden death in those given Bactrim while already taking renin-angiotensin system blockers angiotensin receptor blockers (ARBs), heart medications.

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Scientist Calls for Federal Regulations for Fracking Pollution

Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.

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Study Links Liquid in E-Cigarette to Viral Infections

Study Links Liquid in Electronic Cigarette to Increased Risk of Viral Infections

The National Jewish Health study, links the liquid used in e-cigarettes to a higher risk of respiratory viral infections, whether the liquid contains nicotine or not.

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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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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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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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64 More Plavix Patients File Suit Over Bleeding Side Effects

Another Plavix lawsuit has been filed on behalf of 64 Plavix patients who allege bleeding side effects. Plavix (clopidogrel) is a blood thinner prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, such as the heart attacks and strokes it is ...

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FDA Investigating Potential Health Risks of Brain Deposits of Gadolinium-Based MRI Contrast Agents

Recent studies have shown that gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) deposit in the brain of some patients who have repeated scans. The Food and Drug Administration (FDA) is investigating possible health risks of such deposits.

Recent publications in the medical literature—including an article published in March in Radiology—have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration of the agent. The FDA says it is not known whether gadolinium deposits are harmful or can lead to adverse health effects. Continue reading

Posted in Health Concerns, Pharmaceuticals |

Study: Antibiotics Associated with Increased Risk of Juvenile Arthritis

The use of antibiotics was linked to an increased risk of cancer in a study conducted by researchers from Rutgers University, University of Pennsylvania and Nemours A.I. duPont Hospital for Children. Findings showed that children who were exposed to antibiotics were twice as likely to develop juvenile arthritis compared to those who were not. As additional courses of antibiotics were taken, the risk increased; the risk was strongest within one year of taking antibiotics. The study was published in the journal Pediatrics.

Researchers conducted the study in light of evidence suggesting that children may be more likely to develop chronic diseases, including inflammatory bowel disease, when exposed to antibiotics. “Antibiotics are one of the better known disruptors of human microbial communities,” said lead author Daniel Horton, a postdoctoral research fellow working in the Department of Pediatrics at Rutgers Robert Wood Johnson Medical School and biomedical informatics master’s degree candidate in the Rutgers School of Health Related Profession. Continue reading

Posted in Legal News |

Class 2 Recall Issued for Nearly 2,000 Medtronic MiniMed Insulin Pumps

Medtronic has recalled nearly 2,000 units of its MiniMed 640G insulin pumps, according to a notification posted on the U.S. Food and Drug Administration’s (FDA’s) website. The device was distributed in the following 10 European countries: Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom. Medtronic intends to submit the pump for PMA submission later this year, Fierce Medical Devices reports.

According to the recall notice, there may be instances where “the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.” The recall was designated as Class 2 by the FDA, meaning that exposure to the recalled device might lead to temporary or reversible adverse events or that there is a low risk of serious events. Continue reading

Posted in Legal News |

Chrysler Agrees to Record Fines and Penalties and Must Buy Back Defective Vehicles

Chrysler Agrees to Record Fines & Penalties

Chrysler Agrees to Record Fines & Penalties


Fiat Chrysler Automobiles could pay up to $105 million in fines and penalties and must buy back defective vehicles in an agreement with the federal government that will also require an independent monitor to oversee future vehicle recalls.

The automaker may have to buy back more than half a million vehicles with defective suspension parts if owners wish to sell those vehicles back to Chrysler, Fortune reports. Continue reading

Posted in Defective Products, Motor Vehicles | Tagged , , , , |

Woman’s Eyesight Endangered by Serious Side Effect of Tylenol

Woman’s Eyesight Endangered by Tylenol Side Effect

Woman’s Eyesight Endangered by Tylenol Side Effect


After taking Tylenol when she felt sick on vacation, an Indiana woman suffered a serious skin reaction like burns, over 40 percent of her body, and doctors are fighting to save her eyesight.

Stricken while vacationing near Bowling Green, Kentucky, Donna Emley, of Fort Wayne, Indiana, was diagnosed with Stevens-Johnson syndrome, a serious disorder of the skin and mucous membranes. Stevens-Johnson is usually a reaction to medication or an infection, according to the Mayo Clinic. Emley was sent to the burn unit at Vanderbilt University Medical Center in Nashville for treatment. Continue reading

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

Ikea Warns of Dangers with 27 Million Dressers Following 2 Fatalities

Ikea Warns of Dangers with 27M Dressers Following 2 Fatalities

Ikea Warns of Dangers with 27M Dressers Following 2 Fatalities


Following the tragic deaths of two toddlers, Ikea is warning of the risks with its chests and dressers. Associated Press reports that Ikea chests resulted in fatal injuries when they tipped over and fell on two boys last year. The Swedish company is warning that the 27 million chests and dressers should be kept away from children if they are not mounted to a wall. CPSC spokesman Scott Wolfson said “They are unstable when built and used without a wall anchoring device,” according to AP. Consumers who have the furniture can obtain a free kit from Ikea for mounting to a wall; the kit will be available for consumers who purchased chests and dressers above specific heights.

In February 2014, a Malm six-drawer chest fell on a two-year-old boy in West Chester, Pennsylvania; he was fatally pinned against his bed. A three-drawer Malm chest fatally injured a 23-month old boy from Snohomish, Washington when it fell over. Continue reading

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

Legislation Before Congress Would Weaken Testing and Regulation of Medical Devices

Legislation Would Weaken Regulation of Medical Devices

Legislation Would Weaken Regulation of Medical Devices


In a time when ever-increasing numbers of Americans rely on medical devices, legislation currently before Congress could weaken the standards the Food and Drug Administration (FDA) uses to determine a device’s safety and efficacy.

The 21st Century Cures Act would allow devices to reach the market using case-study evidence rather than clinical trial results to demonstrate the device’s safety and effectiveness. Current approval process requires one clinical trial (new drugs, in contrast, usually require two trials). Writing in an op-ed piece in the New York Times, cardiologists Rita Redberg and Sanket S. Dhruva warn that medical devices, some of which are permanently implanted in the patient’s body, should have stricter approval requirements. Only a small minority of medical devices undergo randomized, controlled, blinded clinical studies—considered the gold standard in trials. Continue reading

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

FDA Convening Panel to Reconsider Safety of Essure Birth Control System

FDA Convening Panel to Reconsider Safety of Essure

FDA Convening Panel to Reconsider Safety of Essure


On September 24, 2015, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration (FDA) will meet to discuss the risks and benefits of Bayer HealthCare’s Essure birth control system.

The panel will seek expert scientific and clinical opinion on the risks and benefits of the Essure, a method for nonsurgical permanent female sterilization, and will hear testimony from doctors and scientists, as well as from women who have had the device implanted. The committee will evaluate scientific evidence about the safety and effectiveness of the Essure System, including perforation/migration of the device, device removal, chronic pain, allergic reactions, unintended pregnancy, and ectopic pregnancy. The committee will provide recommendations to the FDA about appropriate use of the device, product labeling, and the potential need for additional postmarket clinical studies. Continue reading

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

Data Breach for Ashley Madison, Dating Site that Promotes Affairs

Data Breach for Ashley Madison, Dating Site

Data Breach for Ashley Madison, Dating Site


Ashley Madison, an online dating service with the slogan “Life is Short. Have an Affair,” reports that the site has been breached and hackers have obtained personal data about the service’s millions of members.

The Impact Team, the name given by the group behind the attack, said they had stolen information on Ashley Madison’s 37 million members. The group has leaked a portion of the data and said it will release all if the site is not shut down, the New York Times reports. Continue reading

Posted in Consumer Fraud | Tagged , , , , |

Studies Show Increased Melanoma Risk in Men Who Use Viagra

Increased Melanoma Risk in Men Who Use Viagra

Increased Melanoma Risk in Men Who Use Viagra


A study published in the Journal of the American Medical Association shows an increased risk of melanoma for men who use the erectile dysfunction drug Viagra.

Men who use Viagra have almost twice the melanoma risk, according to a study, CBSMiami reports. Researchers followed 25,000 thousand male health care professionals were followed for ten years as part of the research, tracking which men developed melanoma and whether they used Viagra (sildenafil). Continue reading

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

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