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…)

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 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…)

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…)

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.