Make sure you get from your doctor what to look for adverse events from Pradaxa or warfarin or statins.
http://www.cardiovascularbusiness.com/index.php?option=com_articles&view=article&id=34247:report-pradaxa-tops-fdas-list-for-serious-adverse-events
Dabigatran topped the list of direct reports to the FDA of serious
adverse drug events in 2011, according to an analysis by the Institute
for Safe Medication Practices. Dabigatran (Pradaxa, Boehringer
Ingelheim) had the largest number of direct reports, at 817, followed by
warfarin, at 490.
Reports from both the manufacturer and direct
reports pointed to 3,781 serious adverse events associated with
dabigatran in the U.S. in 2011, according to the analysis. Analysts
identified 542 patient deaths, 2,367 cases of hemorrhage, 291 cases of
acute renal failure, 644 cases of stroke and 15 cases of suspected liver
failure. The FDA approved the use of dabigatran for the prevention of
stroke and systemic embolism in non-valvular AF patients in 2010.
Warfarin had 1,106 cases overall in 2011, including 72 deaths. The
authors noted that in past analyses, warfarin consistently ranked near
the top for direct reports to the FDA.
“Two drugs that inhibit
the formation of blood clots ranked first and second among all direct
reports to the FDA in 2011, emphasizing that the combination of a
vulnerable patient population and a powerful pharmacological action rank
among the highest risks in prescription drug therapy,” the authors
wrote in the report, QuarterWatch. “While a therapeutic goal of
preventing strokes, pulmonary embolism, and other harm through unwanted
blood clots is a worthy objective, these results demonstrate that
treatment is accompanied by substantial risks.”
The European Medicines Agency (EMA) reported May
25 that its post-marketing data on dabigatran showed that the frequency
of occurrence of fatal bleedings was significantly lower than what was
observed in clinical trials. Nonetheless, the EMA called for an update
of product information to give physicians clearer guidance on how to
reduce and manage the risk of bleeding.
By QuarterWatch’s count,
the FDA received 179,855 reports of serious, disabling and fatal
adverse drug events in the U.S. in 2011, an increase of 9.4 percent from
2010. The majority, 88 percent, were submitted by drug manufacturers
while the remaining 12 percent were submitted to the FDA by health
professionals and patients.
In a section on suspect drugs linked
to severe side effects in the U.S., the report listed simvastatin
(Zocor, Merck) and rosuvastatin (Crestor, AstraZeneca) as first and
second most frequently identified drugs linked to severe muscle damage
in 2011. Simvastatin had 123 cases and rosuvastatin 73 cases. By
contrast, atorvastatin (Lipitor, Pfizer) accounted for only 15 reported
cases.
QuarterWatch is published by the Institute for Safe
Medication Practices, a Horsham, Pa.-based nonprofit organization that
monitors adverse drug events reported to the FDA. The QuarterWatch
reports are funded through the institute and are based on analyses of
computer excerpts that the agency releases for research use from its
Adverse Event Reporting System.
Use the labels in the right column to find what you want. Or you can go thru them one by one, there are only 28,972 posts. Searching is done in the search box in upper left corner. I blog on anything to do with stroke.DO NOT DO ANYTHING SUGGESTED HERE AS I AM NOT MEDICALLY TRAINED, YOUR DOCTOR IS, LISTEN TO THEM. BUT I BET THEY DON'T KNOW HOW TO GET YOU 100% RECOVERED. I DON'T EITHER, BUT HAVE PLENTY OF QUESTIONS FOR YOUR DOCTOR TO ANSWER.
Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.
What this blog is for:
My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.
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Thanks for sharing enthusiastic information, keep it up.
ReplyDeleteIf this is the case, why the manufacturer didn’t put a warning to its product label as a warning protocol? At least, the patient can be aware of the side-effects and therefore avoid excessive bleeding by avoiding possible injuries. Excessive bleeding can be as dangerous as the stroke so the risk/danger is still the same whether a patient take this drug or not. Also, I observed especially online that cases of a Pradaxa lawsuit keep rising which indicates that the drug is really a mess. Better take Warfarin, though it needs frequent blood monitoring but at least the effects can be reversed.
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