"May 3, 2011 -- Bristol-Myers Squibb has recalled 1.85 million 5-milligram Coumadin tablets in the U.S.
The recalled lot of Coumadin (number 9H49374A, expiration date Sept. 30, 2012) was sold to pharmacies in 1,000-tablet bottles and r"...
- COUMADIN can cause major or fatal bleeding [see WARNINGS AND PRECAUTIONS].
- Perform regular monitoring of INR in all treated patients [see DOSAGE AND ADMINISTRATION].
- Drugs, dietary changes, and other factors affect INR levels achieved with COUMADIN therapy [see DRUG INTERACTIONS].
- Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see PATIENT INFORMATION].
COUMADIN (warfarin sodium) is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4- hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following:
Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether.
COUMADIN tablets for oral use also contain:
|All strengths:||Lactose, starch, and magnesium stearate|
|1 mg:||D&C Red No. 6 Barium Lake|
|2 mg:||FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake|
|2-1/2 mg:||D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake|
|3 mg:||FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake|
|4 mg:||FD&C Blue No. 1 Aluminum Lake|
|5 mg:||FD&C Yellow No. 6 Aluminum Lake|
|6 mg:||FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake|
|7-1/2 mg:||D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake|
COUMADIN for injection for intravenous use is supplied as a sterile, lyophilized powder, which, after reconstitution with 2.7 mL Sterile Water for Injection, contains:
|Warfarin sodium||2 mg per mL|
|Sodium phosphate, dibasic, heptahydrate||4.98 mg per mL|
|Sodium phosphate, monobasic, monohydrate||0.194 mg per mL|
|Sodium chloride||0.1 mg per mL|
|Mannitol||38.0 mg per mL|
Sodium hydroxide, as needed for pH adjustment to 8.1 to 8.3
What are the possible side effects of warfarin (Coumadin, Jantoven)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using warfarin and call your doctor at once if you have a serious side effect such as:
- pain, swelling, hot or cold feeling, skin changes, or discoloration anywhere on your body;
- sudden and severe leg or foot pain, foot ulcer, purple toes or fingers;
- sudden headache, dizziness, or weakness;
- unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle...
What are the precautions when taking warfarin sodium (Coumadin)?
Before taking warfarin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as anemia, hemophilia), bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood vessel disorders (such as aneurysms), recent major injury/surgery, liver disease, alcohol use, mental/mood disorders (including memory problems), frequent falls/injuries.
It is important that all your doctors and dentists know that you take warfarin. Before having surgery or any...
Last reviewed on RxList: 10/2/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Coumadin Information
Coumadin - User Reviews
Coumadin User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.