Coumadin Recall Issued Over Questionable Ingredient in Blood Clot Drug

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Uncertainty about the quality of a key ingredient in Coumadin has led to a recall of eight lots of the widely used blood thinner, which is used to reduce the formation of blood clots. 

The FDA announced the Coumadin recall on July 12, after Bristol Myers-Squibb determined that the effectiveness of their drugs may change over time. The pills contain an ingredient known as isopropanol, which is used to keep the drugs active ingredient in a crystalline state. However, the drug maker is now warning that in certain recalled lots of Coumadin, the isopropanol may not meet quality specifications.

If the quality of the isopropanol is poor, it could lead to Coumadin being less potent or overly potent. If the drug becomes less effective, it could cause increased risk of blood clots, heart attack or stroke. If it is too potent, it increases the risk of bleeding.

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Coumadin (warfarin) was approved for use in the early 1950s and is the most commonly use anticoagulant in the U.S. It is also available under the brand names Jantoven, Marevan, Lawarin and Waran, and as a generic. It is used for the prevention of blood clots and embolisms.

The Coumadin recall affects three lots of physician sample blister packs of Coumadin 1 mg tablets and five lots of hospital unit dose (HUD) blister packs of Coumadin 1 mg tablets. The physician sample blister packs have lot numbers of 9A48931A, 9A48931B and 9A48931C, with an expiration date of January 2012. The HUD packs have the lot numbers of 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiration dates of June 2011 through November 2012.

There have been no reports of injuries or illnesses related to the blood clot drug recall. Any patients who believe they have pills that are affected by the recall should contact their physician to ensure that their anticoagulant treatment can continue uninterrupted.

Any adverse reactions should be reported to the FDA’s MedWatch adverse events reporting program at www.fda.gov/medwatch.

Tags: Blood Clot, Bristol Myer Squibb, Heart Attack, Pulmonary Embolism, Stroke
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9 Comments

Carol
My condolences to everyone who has lost someone due to this rat poison! My beautiful 85 year-old mother has been on this poison for the past 2 1/2 years, her life is hot to hell! She has multiple chronic medical conditions and is on 5 different medications. Over the past 2 1/2 years she has gotten progressively worse to a point where she basically can just sit in her char all day. Prior to this she used to walk at least 3 – 4 times a day with the aid of her walker for an hour each time. Now she barely has a breath to walk from one point of the living room to the next. She has muscle cramps, nausea (because of the lactose in the coumadin as she is lactose intolerant), loss of appetite, cold intolerance, shortness of breath, hair loss, panic attacks, memory loss, headaches. What does the doctor say “It’s not the medication” It’s the bloody medication all right, there something they are not telling people about this medication. So many people’s lives and their families have changed. My mum has multiple dvt’s in her leg. I have researched alternatives to coumadin and have read about nattokinesse. The pharmaceutical companies are unconscionable & need to be held accountable for ruining people’s lives. Class action lawsuit is the only way to make them stop and take notice as they are driven by profits and treating the symptoms, not getting to the root cause. Of course that wouldn’t make any sense would it as there is more money for them in maintenance – not cures..
catherine
My mother, a brilliant composer musician, educater& business women, was prescribed coumadin 9 years ago after a single AF incident. She was traveling with my Father (husband of 50 years and in love still) in their motor home had no liquids all day totally dehydrated. That night she woke with strange feeling and was seen by a emergency room doctor who diagnosed her as AF and gave her Coumadin! 9 years later and still on it , she is suffering with advanced alzheimers, high blood pressure and her blood is called “thick or Sticky”. Also has had numerous other drugs because who knows what or why. 2 different blood pressure meds with moderate rick interactions. It’s so messed up!!!!!!!!!!!!! I truly believe the only reason she has problems today is no doctor would or could take the liability associated with stopping her prescription . Take her off could mean loss of a job or worse for the med group if something occured. After studying preventative medicine food and nutrician (for 12years), that her doctors are responsible for not only her malnutrician, (no vitamin k1 or K2 for 9 years, “leaky brain” from coumadin & alheimers but for the high blood pressure and sticky blood as well . I am searching for legal advice! I owe it to my mother to find justice for what has happened!!!! HELP!!!!!!!!!!! I think class action law suit !!!!!!!!!!!!!!!!
Shirley
My husband was very healthy until the end of last year. He was given a prescription of the generic version of Coumadin. Now he had a massive stroke just last Thursday, March 3, 2011 and could not speak and see me. The emergency doctor told me he had a big brain bleeding that an operation is not an option. The next day he was in a coma until now. Now I am so upset because I even right away said it must be the coumadin because they even raised the dosage for morning and Aspirin in the evening. He was so happy looking forward to our vacation to Florida on the 12th of March then this and I am very angry. Now I am connecting the dots with all the signs that we did not pay attention to. Now I don’t want him to see with all the tubes in the hospital and not responding.Yet the neurologist wont do my request to have EEG on him so i would know if he is brain dead. Please help me make up my decision because I don’t want him to live this way as he would not approve it too because it is not living.
Jennifer
My husband suffered a stroke on May 31, 2010. I would like to know if he may have received this bad “lot” of medicine also! How do I find out? His Dr. simply told him to stop taking the Coumadin and then 14 days later suffered the stroke. This has to be tied together.
donna
i also wanted to add that my husband had started coumadin on 09/21/2010 and he passed away on oct 30 2010..
donna
my husband recently passed away from a aneurysm after taking coumadin for only a month we had no idea there was a recall on coumadin our family has suffered a great loss….
Selina
My mother died 10/19/09 after taking coumadin for 10 days along with plavix. I wasn’t comfortable with her taking this medication because of all the side effects.
Robert
I started on coumadin on 10/05/2010.Is there any problems with the mediation that i received from the hospital.
LOLITA
MY HUSBAND RECENTLY SUFFERED AN ANEURYSM WHILE ON COUMADIN, WHICH CAUSED HIM TO HAVE A SHUNT PUT ITN HIS BRAIN TO DRAIN THE FLUID AND STOP THE BLEEDING. WE HAD NO IDEA THERE WAS A RECALL ON COUMADIN. THIS MAKES ME VERY UPSET, THAT WE WERE NOT TOLD ABOUT THIS RECALL FROM HIS HEALTH CARE PROVIDERS. OUR LIVES HAVE CHANGED TREMENDOUSLY.

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