20 results

• Reversal Agent for Uncontrollable Xarelto Bleeding Delayed by FDA

  August 22, 2016

  Irvin Jackson

  A proposed reversal agent for the blood thinners Xarelto and Eliquis suffered a setback this week when the FDA rejected its approval, asking questions about manufacturing and its potential use with similar drugs.

• Portola To Seek Xarelto Reversal Agent Approval Before End of Year

  November 16, 2015

  Irvin Jackson

  The FDA may soon be asked to approve a reversal agent for the blood thinner Xarelto, which has been linked to uncontrollable bleeding events.

• Heart Attack Risk Increases Following Knee or Hip Replacements: Study

  September 3, 2015

  Irvin Jackson

  Patients who recently underwent hip or knee replacement surgery face a short-term increased risk of heart attacks, according to the findings of a new study.

• Savaysa, New Factor Xa Blood Thinner, To Hit Market With Black Box Warning

  February 9, 2015

  Irvin Jackson

  A new blood thinner approved by the FDA carries a black box warning that it may be less effective in patients with normal kidney functions.

• Xarelto Antidote to Reverse Bleeding Problems May Have Been Found by Portola

  January 12, 2015

  Irvin Jackson

  Clinical trials have shown some success in the development for a Xarelto reversal agent, as manufacturers race to develop antidotes for blood thinners linked to deadly and uncontrollable bleeding problems.

• New Rules Proposed For Conducting Clinical Drug Trials

  December 30, 2014

  Irvin Jackson

  Newly proposed rules would greatly expand the amount of information the public must be given on clinical drug trials.

• Researchers Call For Open Access to Clinical Trial Data

  September 15, 2014

  Irvin Jackson

  More drug researchers are calling for open access to clinical trial data amid distrust for the pharmaceutical industry to police itself.

• OpenFDA Promises Free, Open Access to Vital Health Data

  June 3, 2014

  Irvin Jackson

  The FDA has launched a new open-access database for its drug adverse event reports, which it says is the first step in greater transparency.

• FDA Adverse Event Reporting More Accurate Than Once Thought: Study

  March 20, 2014

  Irvin Jackson

  A new study sheds more light on the accuracy of the FDA's adverse event reporting system, which is often denigrated for its unscientific structure.

• Generic Warfarin Recall Issued Due to Oversized Pills

  June 13, 2013

  Irvin Jackson

  Some generic warfarin blood thinner pills have been recalled because they may be too large, which could cause patients to suffer excessive bleeding.