Coumadin-FDA Safety Advisory 10/6/2006

[Ross]

http://www.fda.gov/cder/Offices/ODS/MG/warfarinMG.pdf

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Bristol-Myers Squibb notified pharmacists and physicians of
revisions to the labeling for Coumadin, to include a new patient
Medication Guide as well as a reorganization and highlighting of the
current safety information to better inform providers and patients.

The FDA regulation 21CFR 208 requires a Medication Guide to be provided
with each prescription that is dispensed for products that FDA
determines pose a serious and significant public health concern.

 

[Ross]

http://www.fda.gov/cder/Offices/ODS/MG/warfarinMG.pdf

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Bristol-Myers Squibb notified pharmacists and physicians of
revisions to the labeling for Coumadin, to include a new patient
Medication Guide as well as a reorganization and highlighting of the
current safety information to better inform providers and patients.

The FDA regulation 21CFR 208 requires a Medication Guide to be provided
with each prescription that is dispensed for products that FDA
determines pose a serious and significant public health concern.

All of this is nice, but until Doctors and Labs get with the program, it's meaningless.

 

[Guest]

It even says to not drink cranberry juice nor eat cranberry products.

One death in 50 years that MIGHT be attributed to the combination.

Remember about 4 years ago when some pregnant women in Africa with mechanical valves did not get Lovenox dosage changes based on weight and they died? The FDA in its infinite wisdom then decided that nobody with a mechanical valve should get Lovenox!!! The proper conclusion would have been, "be sure that people get the correct weight-based dose of Lovenox".

 

[Ross]

Well at least they didn't call it a blood thinner!

 

[Sierra Bob]

As I was reading these posts the FDA notice was being didcussed on the Today Show.