Pradaxa Warning: Do Not Remove Blood Thinner From Bottle, FDA Warns
Federal drug regulators warn that the blood thinner Pradaxa will begin to break down if it is removed from the original bottle or blister packages, and must be used within a relatively short period of time after it is opened.
The FDA issued a Pradaxa safety communication on March 29 to alert the public that Pradaxa requires special storage and handling. The drug, approved last October, has the potential to break down and lose potency if taken out of the bottle or blister package it was dispensed in, and should be used within 60 days even when kept in the original container. The current label says it is only good for 30 days.
The FDA’s warning indicates that the agency was concerned many people have a habit of taking pills out of their original packaging and placing them in pill boxes or pill organizers. The agency urges consumers not to do this with Pradaxa.
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Pradaxa (dabigatran etexilate mesylate) was approved in October 2010 for reduction of the risk of stroke and blood clots in patients who suffer from atrial fibrillation. The FDA says that the blood thinner has been prescribed about 128,000 times between October and January.
The FDA urged healthcare providers to make sure that their patients are educated about Pradaxa’s special handling instructions. The agency also recommended that pharmacists place an auxiliary expiration label on the bottle that tells patients that it expires in 60 days. Pharmacists are also instructed only to use the original Pradaxa bottles and to not repackage it in standard amber pill containers.
Boehringer Ingelheim Pharmaceuticals, Inc., the manufacturer, has been asked by the FDA to gather more information on the potency of the drug up to 60 days after its use. That information will be added to the label once the FDA’s review is complete.
KeithAugust 22, 2015 at 3:35 am
This post is a follow up on my Grandmother,Her health never recovered in fact she had 3 ICU stays of almost 1 month each time, she became 100% dependent for everything where before Feb 2011 she was only I need of assistance and could still cook and wash and bathe etc. Her care became a 24-7 ordeal requiring my girlfriend assistance for bathing and bathroom visits every 3-4 hrs day and night. Her p[Show More]This post is a follow up on my Grandmother,Her health never recovered in fact she had 3 ICU stays of almost 1 month each time, she became 100% dependent for everything where before Feb 2011 she was only I need of assistance and could still cook and wash and bathe etc. Her care became a 24-7 ordeal requiring my girlfriend assistance for bathing and bathroom visits every 3-4 hrs day and night. Her personality was profoundly affected with each mini stroke she had, she began getting paranoid and delusional, even more than I realized when upon her death I realized despite our caregiving agreement for my 50% stake in a 2.3 million dollar cash trust was breached , imagine my surprise to learn my sweet Grandmother had lied tome and continued using me as a personal slave at this point being rude and insulting saying hurtful things, basically after Pradaxa and Sotalol her life as mine was forever changed/ ruined. She was never supervised despite Soltalols requirement for 3 days observation. As a result of her taking Pradaxa she was awarded $125,000 just after her death, they said as she was 91 they do not pay as if she was 30 and a mother of small children. My life and future were forever altered, I face the indignity other delusions that nobody paid any attention to until after her passing as it behooved them to believe I was abusive to her which is absolutely false, she had the means to go any where any time but would never go without me. I have an atty and am wining in probate court however lost 40% to lawyers fees and costs . My Grandmother died Feb 23 2013, from Feb. 2011 to Feb 2013 her life as mine was made a total hell on earth and my life after was to be completely different than being the insolvent defender of myself now simply to get part of what I relied upon much to my detriment
KeithSeptember 16, 2011 at 1:19 pm
My Grandmother (91) was prescribed Sotalol and Pradaxa by her cardiologist, every caution seemingly ignored it appears to me as My Grandmothers age, weight, renal # 30-40 and sore spoot in stomach lifelong, were completely ignored. Within days she was so weak she could not rise from bed, Doctors office basically said its expected for a week and come in next week! I called 911 finally as she was[Show More]My Grandmother (91) was prescribed Sotalol and Pradaxa by her cardiologist, every caution seemingly ignored it appears to me as My Grandmothers age, weight, renal # 30-40 and sore spoot in stomach lifelong, were completely ignored. Within days she was so weak she could not rise from bed, Doctors office basically said its expected for a week and come in next week! I called 911 finally as she was white and pale! She required 4 transfusions and 10 days intensive care unit, followed in a week by another week stay and more blood given! 7 months now and her life was ruined , She cannot walk over 300 ft , where before could shop for 4 hours! She needs a walker and has become feeble and frail ! This info I learn after from Drs and reading says she was nearly killed by malparactice! several Drs and the hospitalist said to give Pradaxa to a 90 yr old as her was insanity, there is no counter agent and its $240 vs $4! Coumadin She had 7 yrs ago with no issues and was later takken off, only when complaining of dizzyness was she offered Pradaxa ! No warnings nothing! The Hospitalist had never seen Pradaxa yet in the ER and had never seeen an ofver dose either as this is what he said occured!
JoeMay 16, 2011 at 7:35 pm
Had bloodclot after quitting coumadin and starting pradaxa.
peterApril 25, 2011 at 2:34 pm
I LEAVE MY SECOND DOSE OF PRADAXA OUTSIDE ITS CONTAINER TO REMIND ME TO TAKE IT SO IT IS OUT OF ITS CONTAINER FOR ABOUT 12 HOURS. IS THIS A PROBLEM? IS THERE A SAFE TIME WINDOW FOR DOING THIS?
HELENApril 3, 2011 at 7:46 pm
Concerning Pradaxa storage printed on box and label requiring 77 F with an excursion permitted between 59 - 80 F. How does one maintain a constant 77 F temperature?
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