FDA backs previous stance on Pradaxa bleeding risks
Federal health officials have issued an update on its stance on the new blood thinner drug Pradaxa, indicating the risk of severe bleeding associated with the drug is no more significant than any other drugs available on the market for the same purpose. This stance goes against a lot of current research that found Pradaxa to carry … [Read more...] about FDA backs previous stance on Pradaxa bleeding risks
Pradaxa Study Sees Higher Bleeding, Clot Risk after Atrial Fibrillation Ablation
A study published in February reported that patients who took Pradaxa (dabigatran) following radiofrequency ablation to treat atrial fibrillation experienced more bleeding and blood clots compared to people who were treated with warfarin post-procedure. The authors of the study, published in the Journal of the American College of … [Read more...] about Pradaxa Study Sees Higher Bleeding, Clot Risk after Atrial Fibrillation Ablation
Pradaxa, Other Dangerous Drugs Make it to Market Thanks to Quick FDA Approvals
A new study has questioned the Food and Drug Adminstration’s (FDA) process for approving new prescription drugs, especially after the agency allowed a trio of products to reach the market without serious questions about their safety being answered, including the blood thinner Pradaxa. Pradaxa side effects have been blamed for more … [Read more...] about Pradaxa, Other Dangerous Drugs Make it to Market Thanks to Quick FDA Approvals
Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke
The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, … [Read more...] about Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke
EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects
Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug's label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not … [Read more...] about EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects
Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims
The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial hemorrhage which doctors were … [Read more...] about Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims
Pradaxa Bleeding Deaths Reported in 117 More Patients, ISMP Finds
Another 117 bleeding deaths possibly linked to Pradaxa were reported to the U.S. Food & Drug Administration's (FDA) Adverse Event Database, according to the Institute for Safe Medicine Practices (ISMP) latest QuarterWatch report. The drug watchdog also found that Pradaxa was associated with a total 856 reports of serious, … [Read more...] about Pradaxa Bleeding Deaths Reported in 117 More Patients, ISMP Finds
