The U.S. Food and Drug Administration (FDA) announced that the manufacturer of the anticoagulant warfarin sodium—sold under the brand name Coumadin—ordered a recall of one lot of 1,000-count bottles of the product because the tablets were over-dosed. Potential side effects include blood in the urine or blood in the stool, bruises from unknown events, and coughing up blood.
What Is Coumadin? When Is It Prescribed?
Coumadin is the brand name for the drug warfarin sodium. Made and sold by American pharmaceutical company Bristol-Myers Squibb, Inc., this prescription medication is used to prevent strokes, heart attacks, and blood clots. Warfarin is one of the oldest “blood thinners” on the market, having received FDA approval in 1954. Many companies sell their own brands and some sell it generically. It is one of the most common anticoagulants on the market, and doctors prescribe it in the form of oral tablets.
Coumadin is referred to as a “blood thinner,” which is a slight mischaracterization because it doesn’t reduce users’ blood pressures. Instead it prevents the synthesis of vitamin K-dependent clotting factors. Without these clotting factors, blood doesn’t coagulate as easily. This can prevent spontaneous or dangerous blood clots and embolisms from forming inside of people’s blood, saving those who have recently suffered strokes or heart attacks.
In May 2011, Bristol-Myers Squibb ordered a voluntary Coumadin recall because one lot holding 1000-count bottles of Coumadin contained pills with excess amounts of warfarin. The lot number is 9H49374A, and it expired on September 30, 2012. The FDA reported no injuries associated with the recalled pills.
Coumadin Might Cause Life-Threatening Side Effects
Coumadin Hemorrhage Side Effects
The FDA’s Coumadin drug label advises physicians and users that Coumadin can cause fatal hemorrhages. According to a study conducted in the New England Journal of Medicine, out of 99,628 hospitalizations of the elderly, 33 percent involved warfarin. The Coumadin recall occurred because Bristol-Myers Squibb feared the excess warfarin dosage would injure users by preventing their blood from clotting even if it needed to. Symptoms of Coumadin hemorrhage include:
- unusual bleeding in the gums
- frequent nose bleeds
- heavier-than-normal menstrual or vaginal bleeding
- severe or uncontrollable bleeding
- blood in urine (pink or brown color)
- blood in stool (red or black)
- bruises caused by unknown events
- bruises that increase in size
- coughing up blood or blood clots
- vomiting blood or vomit that resembles coffee grounds
Other Coumadin Side Effects
- tissue necrosis (Fewer than 0.1 percent of users have suffered skin and tissue deaths. Some of them required organ amputation.)
- embolisms (Usually these affect the liver, kidneys, pancreas or spleen, but one symptom is referred to as “purple toes syndrome.”)
- immune system disorders
- vascular disorders
- liver disorders
- gastrointestinal disorders
- skin disorders
- respiratory disorders
Those experiencing adverse Coumadin side effects should consult with their physicians promptly.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Coumadin lawsuit on your behalf if necessary.
If you have taken Coumadin and believe it harmed you, contact RLG today.