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monitoring 4 articles

New blood thinner Pradaxa linked to major hemorrhages


The man had fallen at home. It was a ground-level fall and likely one that would not raise concern except that he was 83 and he had just started on a new blood thinner. Shortly after reporting to the emergency room after his fall, the man’s health began to deteriorate, and within hours he was dead. The case is the center of a report published in the January 2012 Journal of Neurosurgery that raised questions about serious bleeding events associated with a newly approved blood thinner by the name of Pradaxa. Pradaxa, manufactured by Ingelheim Boehring, was approved by the ... Read More

Vehicular heatstroke warning devices ineffective, NHTSA warns

Safety products designed to alert parents about children accidentally left in dangerously hot vehicles are unreliable, federal safety regulators said Monday. The National Highway Traffic Safety Administration (NHTSA) made the announcement amidst a push to raise awareness of auto safety concerns affecting children, including efforts aimed at preventing heatstroke death and injuries in children left in unattended vehicles. According to the agency, 527 children have died from heatstroke injuries they received by being locked in hot vehicles – about 38 deaths per year on average. Heatstroke is the leading non-crash, vehicle-related cause of death for children. NHTSA also warned that ... Read More

Consumers Union fights for more oversight of medical devices

The Consumers Union (CU) is hoping to close a loophole in the approvals of medical devices that allows them to be cleared for marketing in the United States with almost no government regulation, testing or monitoring. According to its mission statement, CU is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU also publishes the magazine Consumer Reports and the website ConsumerReports.org. Currently, medical devices considered moderate-risk, such as transvaginal mesh and artificial hips, are approved through an accelerated process that ... Read More

FDA monitored emails of staff who questioned medical device safety

A group of former and current Food and Drug Administration (FDA) officials have filed a lawsuit against the agency alleging the FDA secretly monitored their private email after they questioned the approval of certain medical devices which they felt put the public’s health and safety at risk. The group of nine doctors and scientists told members of Congress and the incoming Obama administration in 2008 that they were shocked to find medical devices they had researched had been approved by the FDA. In 2009, after Obama was elected but before he took office, the plaintiffs sent Obama’s transition team a ... Read More