Public Health Advisory: FDA Recommendations Concern ing the Use of NSAIDs

[Brian, ASN, RN]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The FDA issued a Public Health Advisory summarizing the agency's recent

recommendations concerning the use of non-steroidal anti-inflammatory drug

products (NSAIDs), including those known as COX-2 selective agents. This

advisory was issued because of recently released data from controlled

clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex,

and Bextra) may be associated with an increased risk of serious

cardiovascular events (heart attack and stroke) and after release of

preliminary results from a long-term clinical trial which suggested that

long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn

and other trade name and generic products), may be associated with an

increased cardiovascular risk compared to placebo. The public health

advisory is an interim measure, pending further review by FDA of data that

continue to be collected.

Read the MedWatch 2004 safety summary, including links to the PHA and FDA

Talk Paper, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#nsaids

[Jedi]

Thanks Brian -

I had my own bad experience with Celebrex. I stared having problems breathing and had the "impending sense of doom". It was very frightening. I called a friend who lived close by. She came and stayed with me until I started feeling better. I never took the drug again. That was years ago.

I hope that nurses who use Bextra at work talk this issue up with doctors to see if there is a different drug that can be used. It's not worth it to wait and see if something bad happens. We should all pay attention to these kind of warnings and try to move to different drugs that are safe and get the job done.

Thanks

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The FDA issued a Public Health Advisory summarizing the agency's recent

recommendations concerning the use of non-steroidal anti-inflammatory drug

products (NSAIDs), including those known as COX-2 selective agents. This

advisory was issued because of recently released data from controlled

clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex,

and Bextra) may be associated with an increased risk of serious

cardiovascular events (heart attack and stroke) and after release of

preliminary results from a long-term clinical trial which suggested that

long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn

and other trade name and generic products), may be associated with an

increased cardiovascular risk compared to placebo. The public health

advisory is an interim measure, pending further review by FDA of data that

continue to be collected.

Read the MedWatch 2004 safety summary, including links to the PHA and FDA

Talk Paper, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#nsaids