Use Coumadin Blister Packs? Take note of recent recall

Coumadin Recall / Bristol Myers

1 mg Tablet Blister Packs only

Recall Notice :  Posted  from FDA / MedWatch

AUDIENCE: Hematology, Cardiology, Risk Manager

RECALL INFO: Bristol-Myers Squibb determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of bleeding.

The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.

BACKGROUND: The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.

RECOMMENDATION: See the company Press Release for additional contact information. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

To Read the MedWatch safety alert, including a link to the company press release click here


I am not a rat. I am a stroke survivor that had a congenital heart defect called PFO (patent foramen ovale) and I fought like hell to get it fixed

by David Dansereau for

Life after a stroke can be like living with a ticking time bomb.  The reality is that a second, possibly fatal stroke can very well follow the first.  In 2006, I survived a second stroke and shortly thereafter I vowed to make that one my last.  I researched all my treatment options, and as it turns out after 9 months of frustration I guess you could say I finally “qualified” to have my PFO closed “off label”.   What that really means is essentially my wife and I fought like hell to get a better chance at a treatment outcome we could both live with.   In the end, I weighed medical management (drug therapy) vs. surgically correcting my underlying heart defect.  My stroke could not be attributed to a disease process like hypertension or uncontrolled hyperlipidemia and no drugs or lifestyle modifications were going to be effective at reversing my risk of another stroke without possibly putting me at risk of further potential drug complications.  As the title of this post suggests, I was born with a congenital heart defect called a PFO that caused my stroke, and I decided a drug (yes, also used to kill rats) was not the therapy of choice for me for the rest of my life.

My decision was not an easy one, but either is rehabilitating from a stroke and I say this cautiously knowing that many reading this may now be faced with the same difficult decision of how to best respond to take back their own health.

I emphasize, you should speak with your own physician throughout the course of your own therapy and ask plenty of questions.  The decision I made was unique to how I envisioned I wanted to live my life after my stroke.  Your life goals should provide the blueprint for your own health plan, not your insurance carriers plan for your care.

Honestly, I’ve had this article ready to post for several weeks now.  I actually started this response after a comment that appeared on my blog ( about alternatives to thinning your blood. In response to my post I was asked through a private comment on my blog why I didn’t just stay on drug therapy after my stroke since Coumadin seemed like the “simple solution” to prevent another stroke.  Well, I have to put this out there that it simply isn’t quite that “simple”.

Here’s what you should know:

Yes, Warfarin is still used as rat poison.  This fact certainly got my attention when I was advised to start Coumadin therapy. I hope that you have already researched this medication on your own.  I mention it not to scare you but to make an important point:  If taken in large quantities, Warfarin (brand name Coumadin) can cause severe and even fatal bleeding. When given as a medication however and monitored by blood tests, it is reported to be safe but not without a long list of potential drug complications as reported by the National Institute of Health’s (NIH) Pub Med Website.  Here’s what they have to disclose on what side effects this antithrombotic medicine can cause:

Warfarin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • gas
  • change in the way things taste
  • tiredness
  • pale skin
  • loss of hair
  • feeling cold or having chills

If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • hives
  • rash
  • itching
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, or eyes
  • hoarseness
  • chest pain or pressure
  • swelling of the hands, feet, ankles, or lower legs
  • fever
  • infection
  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • flu-like symptoms
  • joint or muscle pain
  • difficultly in moving any part of your body
  • feelings of numbness, tingling, pricking, burning, or creeping on the skin
  • painful erection of the penis that lasts for hours

You should also know that Warfarin may cause necrosis or gangrene (death of skin or other body tissues). Call your doctor immediately if you notice a purplish or darkened color to your skin, skin changes, ulcers, or an unusual problem in any area of your skin or body, or if you have a severe pain that occurs suddenly, or color or temperature change in any area of your body. Call your doctor immediately if your toes become painful or become purple or dark in color. You may need medical care right away to prevent amputation (removal) of your affected body part.

Warfarin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

In case of emergency / overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • bloody or red, or tarry bowel movements
  • spitting or coughing up blood
  • heavy bleeding with your menstrual period
  • pink, red, or dark brown urine
  • coughing up or vomiting material that looks like coffee grounds
  • small, flat, round red spots under the skin
  • unusual bruising or bleeding
  • continued oozing or bleeding from minor cuts

Even rats it turns out can’t survive for long with all these possible complications of Warfarin (without getting their blood levels checked regularly I guess).  So, don’t be a rat.  If you are using blood thinning meds please get your blood checked regularly.

Certainly, both drug and device-based therapy for PFO carries risks. Antithrombotic medications, like all medicines, have their long list of warnings, but many times we do not take the time to read the fine print.  PFO closure devices, however, are also associated with device-specific complications such as fracture of device elements, device embolization or thrombus formation.

Bottom Line:

Optimal stroke prevention strategies in patients with PFOs have not been established.  I am confident a solution to improving patient care for PFO conditions exists and my involvement with the PFO Research Foundation supports this mission. Yes, I do hold a bias towards PFO closure because my own results have been incredibly positive.   While I did try medical options including antithrombotic medical therapy prior to PFO closure, they did not work in my case.  What I do know is I do think about the long term impact of the implantation of my PFO closure device, because the benefit of PFO closure in patients with stroke has not been clearly demonstrated, and remains unclear and at times controversial.   I hope to help do my part to advance this important PFO research, so I guess you could say I will need to be a rat to help advance the science.


Pub Med Health