black box warning on NSAIDS

Babci · Post by **Babci** » Sun Jun 26, 2005 8:51 pm

Found this in my daily FDA email & thought it was interesting because of my personal problem w/NSAIDS. Black box warnings are a big deal in medicine because they clearly target that medicine as a problem & practitioners need to warn patients of the dangers. Love & light, Rita

FDA RELEASES BLACK-BOX TEMPLATE FOR NSAIDS
The FDA has published an updated labeling template and medication guide for nonsteroidal anti-inflammatory drugs (NSAIDs) - a move that comes roughly two months after the agency requested manufacturers to include new risk information on labeling for the pain drugs.

The new "black-box" warning that will accompany all NSAIDs includes information on cardiovascular and gastrointestinal risks, according to the FDA, which released the new labeling information in mid-June. The black-box risk information reads as follows:

Cardiovascular: "NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk."

Gastrointestinal: "NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events."

In addition to including the black-box warning on NSAID labeling, manufacturers will begin disseminating a medication guide with the pain drugs. The medication guide provides general safety information about NSAIDs, including possible side effects.

annie oakley · Post by **annie oakley** » Mon Jun 27, 2005 1:22 am

I'm glad to see a warning on them. People have no Idea and just take whatever without a thought as to what it may do...I have a boss who said I have a headache,,,,I said I have some trylrnol...she said oh give me about 8 of them...I said NO...I will however give you 2. People are so trusting or ignorant...don't know which. love Oma

Polly · Post by **Polly** » Mon Jun 27, 2005 5:29 am

Thanks, Babci. That is interesting news! And they don't even list the more "minor" adverse effects like diarrhea (MC). If only someone would develop a safe, effective, OTC med for the usual aches and pains. But it doesn't seem to exist. Even Tylenol can be dangerous if the recommended dose is exceeded by a tiny amount, or if it is taken with alcohol. SIGH.

Love,

Polly

barbaranoela · Post by **barbaranoela** » Mon Jun 27, 2005 6:02 am

Babci-----thanks for that piece of information---glad better warnings are starting to be included---

I was telling my aunt that I met BABCI here and that U live in SWANSEE also-----she was like alittle kid when I told her---

Have a great day Babci(Isure do miss mine)
Luv, Barbara (named after my Babci)

kate_ce1995 · Post by **kate_ce1995** » Mon Jun 27, 2005 6:09 am

A great start for sure. But why must they say the risk is greater in elderly patients? HELLO! Some of us had problems before we were 30! Of course, mine was just that "minor" D problem

katy

Sally · Post by **Sally** » Mon Jun 27, 2005 7:55 am

Am I technically an "elderly" person? I am 63 going on 17.

Good news, but it's just a start. I wonder if we should all be going back to using slippery elm for headaches. That is where aspirin comes from. Is that dangerous, too. Herb lady???

Love,

Sally