ISMP REAFFIRMS PRADAXA CONCERNS IN 2012

Cardiovascular Business - Reports on PRADAXA CONCERNS.

ISMP AFFIRMS PRADAXA LINKED TO 542 DEATHS IN US.
A recent report in CARDIOVASCULAR BUSINESS has reaffirmed prior concerns over PRADAXA and an association with adverse events. This report specifically cites to the ISMP (Institute for Safe Medication Practices ) QuarterWatch which confirms the anti-coagulant leads reports of adverse events to the U.S. Food & Drug Administration.

ISMP’s QuarterWatch, Monitoring for FDA MedWatch Reports, notes that Anticoagulants the Leading Reported Drug Risk in 2011, May 31, 2012, New Data from 2011, Quarters 3-4, identify PRADAXA at the top of FDA’s list of drugs with most frequently reported adverse reactions.

The report identifies 3,781 serious adverse events reported in 2011. Of these, 542 patient deaths, 2,367 hemorrhage cases, 291 acute renal failures, 644 strokes and suspicion in 15 liver failures. PRADAXA or DABIGATRAN accounted for so many reports of serious adverse events that it was prominent in several areas as explained in the insert below.

ISMP QuarterWatch Affirms PRADAXA concerns.

The ISMP report notes that PRADAXA was linked to 542 deaths. On the other hand, WARFARIN or COUMADIN related deaths were noted as totaling 72. In sum, this ISMP report confirms that “safety signals” associated with DABIGATRAN continue to mount and raise red flags. Recent label changes are arguably not likely to change prescriber behavior, unless they are connecting the dots and informed of the ISMP’s data.

The sponsors of PRADAXA BLOOD are actively investigating cases involving death, or serious personal injuries, following the use of DABIGATRAN. A FREE CASE EVALUATION is available through use of the contact form below.

APRIL 2012 – PRADAXA SAFETY SIGNALS CONFIRMED BY ISMP IN QUARTERWATCH

PRADAXA SAFETY SIGNALS CONFIRMED BY ISMP BY QUARTERWATCH

On April 5, 2012, the Institute for Safe Medication Practices (ISMP), published the trademarked QuarterWatch. ISMP analyzed FDA MedWatch Reports for the 2nd Quarter of 2011 and specifically updated information regarding PRADAXA (DABIGATRAN EXTILATE).

ISMP QUARTERWATCH CONFIRMS PRADAXA SAFETY SIGNALS & CONCERNS.

ISMP’s QuarterWatch had previously identified and chronicled safety signals involving PRADAXA. In the update, ISMP noted that the 2nd Quarter of 2011 presented patients using PRADAXA with limited choices in dosing, no recommendation for routine kidney function, no routine blood level tests to optimize effects on coagulation. In analyzing information from the U.S. Food & Drug Administration’s AERS (Adverse Event Reporting System) and voluntary MedWatch reports it found that PRADAXA (DABIGATRAN EXTILATE) was suspected in 856 reports of serious, disabling or fatal injuries, which represented more than any other regularly monitored drug. ISMP also reported that this also included 117 reported patient deaths. 

IMSP’s analysis relies upon voluntarily submitted data that is gathered by the FDA. Investigations and lawsuits have been initiated over fatalities associated with PRADAXA, as well as other debilitating injuries. FREE CASE EVALUATIONS are available through the sponsor of this site by using the contact form below.


PRADAXA DEATHS MAGNIFY SAFETY SIGNALS, CONCERNS & WARNINGS

 PRADAXA DEATHS MAGNIFY ADVERSE EVENTS & SAFETY CONCERNS

PRADAXA has only been in use in the United States since October 19, 2010. However, within months of being approved, as discussed here below, there was a significant increase in reports of adverse events associated with use of the blood thinner. It was only approved in two dosing regimens in the United States and whether that plays a role in the increased number of events, coupled with inadequate warnings to patients and physicians remains to be determined. The potential for overdose or too much PRADAXA in the blood exists.

PRADAXA PILLS USED IN U.S. ARE 75 mg or 150 mg.

In January 2012, revised warning labels were issued warning prescribers and users of needed caution when using the blood thinner in patients with compromised kidney function. This is because the primary method of removing PRADAXA from the body is the kidneys. If a persons kidney function is diminished the effects of PRADAXA could be increased thus dramatically impacting the anti-coagulant effect the pills have on blood within that person. Subsequently, as discussed here below, a case report in March 2012, forewarned of the serious risk presented to patients in emergent circumstances where bleeding is initiated and cannot be reversed or stopped. Ironically, the FDA’s communication encourages patients to seek treatment for any fall or injury.

FDA Safety Information 2012: Pradaxa (dabigatran etexilate mesylate) capsules.

FREE CASE EVALUATIONS are available from the sponsor of this site through use of the contact form below.

 

 

ADVERSE EVENTS – ALERTS & SAFETY SIGNALS

ADVERSE EVENTS – ALERTS & SAFETY SIGNALS
PRADAXA (DABIGATRAN EXTILATE)
has been available in the United States since October 2010. The Institute for Safe Medication Practices (ISMP), A Nonprofit Organization Educating the Healthcare Community and Consumers About Safe Medication Practices, conducts a surveillance program that monitors all serious, disabling and fatal adverse drug events (ADEs) reported to the U.S. Food & Drug Aministration (FDA) by manufacturers and the public. Such reports are communicated by the MedWatch reporting program. The ISMP publishes their analysis in a trademarked publication known as QuarterWatch.

PRADAXA (DABIGATRAN EXTILATE) PROMOTED FOR STROKE REDUCTION.

ISMP, through QuarterWatch, has reported that PRADAXA (DABIGATRAN EXTILATE) literally generated hundreds of adverse event reports for the first quarter of 2011. As summarized by ISMP, in QuarterWatch for the 1st Quarter of 2011, PRADAXA BLOOD was associated with cases of death, permanent disability, and hospitalization. These cases involved hemorrhage and hemorrhagic stroke. Reports of hemorrhagic stroke are particularly noteworthy because PRADAXA is heavily advertised as a means to reduce the risk of ischemic strokes as illustrated above and on-line at www.PRADAXA.com.

While all blood thinners, or anticoagulants, present an increased risk of bleeding or hemorrhage, the effects of PRADAXA (DABIGATRANE EXTILATE) are not readily reversed. This fact, along with little scientific evidence being available regarding how to reverse PRADAXA BLOOD in the event of unplanned bleeding or a medical emergency, arguably raise risks to patients in an unprecedented fashion. Other available blood thinners, like WARFARIN or COUMADIN, which PRADAXA is often contrasted with, do in fact have over 50 years of use in clinical practice and a scientific pathway for reversal.

PRADAXA - NO MONITORING - NO ANTIDOTE.

ISMP’s QuarterWatch reported that it contacted the manufacturer, BOEHRINGER INGELHEIM, and that they “attributed the volume of reports” to them and FDA to the drug’s rapid acceptance and active sales force with established physician relationship. However, promotional materials and public relations campaigns have repeatedly heralded the idea that “PRADAXA is progress” because it requires no blood monitoring. These promotional efforts, coupled with the lack of a quick reversal agent are central issues in pending investigations and lawsuits over PRADAXA BLOOD.

FREE CASE EVALUATIONS are available from the sponsor of this site.

 

PRADAXA BLOOD: FATAL BLEEDING CASE REPORTS

PRADAXA (DABIGATRAN EXTILATE) was approved for use in the United States by the U.S. Food & Drug Administration (“FDA”) in October 2010. In the U.S. it is only approved for use in patients with non-valvular Atrial Fibrillation or AFib. Other indications were considered and denied by the FDA prior to approval. PRADAXA is a blood thinner or anti-coagulant used to minimize the potential for a stroke in patients with AFib. AFib is a heart condition that allows blood to pool in the upper chambers of the heart, thus creating the potential for blood clots that can lead to a stroke.

PRADAXA (DABIGATRAN EXTILATE) BY BOEHRINGER INGELHEIM.

PRADAXA has been in use in France and other countries for a period of years. During November of 2011 PRADAXA BLOOD case reports emerged that raised proverbial red flags for public health authorities worldwide. Essentially, reports of 260 fatalities from PRADAXA BLOOD were confirmed. REUTERS reported on this story and quoted representatives of the manufacturer, BOEHRINGER INGELHEIM, as potentially underestimating fatal bleeding events. In “BOEHRINGER SAYS ABOUT 50 DEATHS RELATED TO PRADAXA“, published on November 2, 2011, a company spokesman was quoted as stating that “Fifty Cases is a reasonable magnitude that has emerged so far“. This story also implied that this estimation was in keeping with expectations based upon clinical studies that were relied upon to bring the drug to market. However, reports in mid-November 2011 estimated deaths were closer to 260 with 21 in the European Union as of that time.

In reviewing subsequent reports, the fact that PRADAXA does not have a known, or readily available antidote or reversal agent is a common theme in PRADAXA BLOOD cases involving fatalities. PRADAXA is a new blood thinner that was heralded as an alternative, or replacement, for WARFARIN or COUMADIN. WARFARIN or COUMADIN has been available for over fifty years and is both easily monitored and reversible. In fact, it is routinely monitored, and dietary restrictions are necessary to prevent inadvertent reversal. On the other hand, PRADAXA has been promoted as an alternative that requires no monitoring, no dietary restrictions and it has thus been promoted as “progress“. However, what “progress” if any PRADAXA represents is open to debate and speculation given it is so new that many questions about dosing, reversal and side effects remain the subject of growing concern.

PRADAXA CASE EVALUATIONS are available from the sponsor of this site through use of the contact form below.

PRADAXA BLOOD SYMPTOMS MAY BE FATAL.