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FDA Advisors Discuss Metal-On-Metal Hip Implants

Advisors to the U.S. Food & Drug Administration (FDA) have been meeting to discuss the safety of metal-on-metal hip implants. The controversial medical devices are at the center of a fiasco that has left many patients suffering with pain, ambulation issues, and the need for repeat surgeries, not to mention a growing number of lawsuits and recalls. The two-day advisory panel, which concludes today, convened yesterday to address side effect and safety issues associated with the devices that were meant to outlast their ceramic and plastic predecessors. The panel has been asked to issue recommendations concerning added warnings and other data for the hip systems and devices, including which patients would and would not benefit from being implanted with the all-metal devices, said the Wall Street Journal. Regulatory issues, including if stricter clinical testing is required, will not be discussed. (more…)

MHRA Issues New Metal-On-Metal Hip Implant Alert

The Medicines and Healthcare products Regulatory Agency (MHRA) just issued a new metal-on-metal hip implant alert.

According to the MHRA, some patients who have been implanted with all-metal hip replacement devices might develop progressive soft tissue reactions linked to the debris released when the devices’ metal components wear on each other. The shedded debris can lead to soft tissue necrosis (death) and can adversely affect surgery results. (more…)

Fresenius Dialysis Under Scrutiny Following Deaths

Fresenius Dialysis is facing scrutiny following reports of deaths linked to drugs used in its clinics. Media outlets, The New York Times and Reuters, write that Fresenius Medical Care (FMC) allegedly neglected to advise dialysis clinics of risks linked to a Fresenius medication, GranuFlo. According to The Times, a U.S. Food & Drug Administration (FDA) official said he was “troubled” that Fresenius only advised its own clinics about the link between dialysis drug GranuFlo and increased risks for fatal cardiac arrest during dialysis, said Reuters. (more…)

Zadroga Act To Cover 50 Cancers

The Zadroga Act is now slated to cover 50 cancers, as long as the cancer can be reasonably linked to the toxic dust that was released in lower Manhattan following the infamous 9/11 attacks on the World Trade Center.

Following an extensive study, the National Institute for Occupational Safety and Health (NIOSH) stated that it “favored” a large broadening of the existing 9/11 health program to include 50 cancers, which included 14 more expansive cancer groupings, said The Associated Press (AP). Free treatment will be available for first responders and residents diagnosed with cancer after exposure to the World Trade Center’s toxic cloud; large compensation payments may also be available under a new rule just proposed by federal health officials, said the AP. Qualification relies heavily on the cancer type and accompaniment of physician proof that the cancer might be connected to the toxic dust. (more…)

Pradaxa Leads In Fatality Reports To FDA

Blood thinner, Pradaxa, is the leader in fatality reports to the U.S. Food & Drug Administration (FDA), according to a new report.

It seems, said FiercePharma, that Pradaxa, manufactured by Boehringer Ingelheim, was involved in more fatality reports to the FDA than any other drug last year. In fact, Pradaxa was the lead in reports in a number of categories: Overall reports, 3,781; deaths, 542; hemorrhage, 2,367; acute renal failure, 291; and stroke, 644, said FiercePharma, citing The Philadelphia Inquirer’s health blog that cited an Institute for Safe Medication Practices’ (ISMP) QuarterWatch program report. The report obtained data from the FDA MedWatch reporting system.

NewsInferno recently wrote that European regulators again asked Boehringer Ingelheim to update the Pradaxa to include additional information about bleeding side effects. The European Medicines Agency (EMA) said that the new guidance should include added information on when Pradaxa must not be taken and information concerning managing patients and reversing the anticoagulant effect, should Pradaxa bleeding occurs.

Approved in Europe in March 2008, Pradaxa was introduced for the prevention of venous thromboembolic events after hip or knee replacement surgery, NewsInferno explained. Pradaxa just had its European approval expanded to cover non-valvular atrial fibrillation for prevention of stroke and systemic embolism. Fatal Pradaxa bleeding events rose after the expansion, according to a Pharma Times report, said NewsInferno.

Pradaxa was the first of a new class of blood thinner medications called direct thrombin inhibitors, and is marketed as a safer alternative to Coumadin (warfarin), NewsInferno explained. Coumadin has some challenging issues including that it can cause dangerous interactions with other medications, that patients must avoid foods high in vitamin K (leafy greens, liver, green tea, cauliflower), and that patient blood must be monitored on a regular basis, noted NewsInferno.

While Pradaxa was touted as avoiding these issues, Pradaxa, Coumadin, and all blood thinners, can cause serious internal bleeding. The major issue is that, with Pradaxa, there are no antidotes to the bleeding, said NewsInferno. As a matter-of-fact, some recent Pradaxa bleeding fatalities have involved patients who died from serious internal bleeds after relatively minor traumas, such as falls involving head bumps. Similar drugs include Eliquis, from Bristol-Myers Squibb and Pfizer, and Xarelto from Johnson & Johnson, noted FiercePharma.

Last year, the FDA initiated a Pradaxa review over reports of bleeding-related side effects. Japanese regulators also directed Boehringer Ingelheim to strengthen Pradaxa warnings, said NewsInferno.

Meanwhile, in the face of mounting controversy and consumer lawsuits, Boehringer Ingelheim just issued a release stating that Pradaxa’s prescribing information has been updated to indicate that Pradaxa is superior to warfarin in reducing ischemic and hemorrhagic stroke, said FiercePharma.

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