FDA warns naproxen users (Aleve)

K.Snyder · Post by **K.Snyder** » Wed Feb 21, 2007 4:39 pm

I know this article is fairly old, but I also know that throughout many peoples busy days they cannot always be on top of everything all of the time, so I wanted to post it here for the sake of anyone coincidentally enough taking Aleve, or any drug related to naproxen.

"ATLANTA, Georgia (CNN) -- The Food and Drug Administration issued a warning to users of the over-the-counter pain reliever naproxen Monday after federal researchers found an increased number of heart attacks and strokes among users.

The warning followed recent studies linking two prescription arthritis drugs to cardiovascular problems.

Naproxen, sold under the brand name Aleve, was part of a study by the National Institutes of Health into whether naproxen or the arthritis drug Celebrex could be used to treat Alzheimer's disease. NIH researchers halted the survey after finding people who took naproxen were 50 percent more likely to have heart attacks or strokes. (Full story)

The FDA urged users to contact their doctors and to avoid taking the drug for longer than 10 days.

Helmut Schdefers, a spokesman for Bayer Healthcare AG, makers of Aleve, said the company was notified late Monday night about the tests. The company has not yet seen the data, he told CNN, but is investigating the matter.

"We are in agreement with FDA regulators that people taking Aleve should consult their doctors and avoid taking the drug for more than 10 days," he said. "Aleve is particularly disturbing because it's an over-the-counter drug,"

FDA drug safety researcher and whistleblower David Graham told CNN's "American Morning," "Over-the-counter drugs are supposed to be the ones that are the absolutely safest."

The NIH study appeared to contradict a National Cancer Institute study last week that found that Celebrex users had a higher risk of heart attack or stroke. The NIH did not find a higher likelihood of those problems in Celebrex users.

Friday, the FDA warned doctors to consider "alternative therapy" for patients taking Celebrex after cancer researchers found a higher risk of cardiovascular problems among patients taking the drug.

The FDA statement said another painkiller, Bextra, has also shown increased risks of cardiovascular events following heart surgery.

Last week's findings came more than two months after drug manufacturer Merck recalled a similar arthritis drug, Vioxx, after similar results. Merck now faces hundreds of lawsuits and potentially billions of dollars in damages.

Vioxx, Bextra and Celebrex are from a family of drugs known as Cox-2 inhibitors, which have been heavily advertised to potential patients. Pfizer pulled ads for Celebrex, but it has disputed the findings and has kept the drug on the market for now.

Graham said the recent issues surrounding the medications point to larger problems at the FDA, such as a lack of agency accountability. The agency, he said, remains in denial about problems with the way drugs are approved.

"I think this asks the larger question, 'Why has FDA not done the job it needs to do to protect America from unsafe drugs?' " he said.

Graham said in his 20 years at the FDA, "safety has been at the back of the bus, if it's on the bus at all."

http://www.cnn.com/2004/HEALTH/12/21/fd ... index.html

Tater Tazz · Post by **Tater Tazz** » Wed Feb 21, 2007 4:41 pm

no wonder why my doctor gave me perscription for pain killers. I use alieve.

RedGlitter · Post by **RedGlitter** » Wed Feb 21, 2007 4:51 pm

Thanks, K.

I stopped taking Tylenol (4-12 daily) so I wouldn't ruin my liver and I moved to Aleve (4 a day) but now I've moved to ibuprofen. It's crazy what you have to watch out for. It was very good of you to post this for us.

K.Snyder · Post by **K.Snyder** » Wed Feb 21, 2007 4:51 pm

Here's a link that may get you to understand over the counter pain reliever drugs a little better.

Only pain relieving drugs because I just happen to have been reading it, and thought it may help.

http://familydoctor.org/862.xml

Tater Tazz · Post by **Tater Tazz** » Wed Feb 21, 2007 4:55 pm

Thank you mr synder for posting that. That was very interesting.

K.Snyder · Post by **K.Snyder** » Wed Feb 21, 2007 4:59 pm

RedGlitter;556727 wrote: Thanks, K.

I stopped taking Tylenol (4-12 daily) so I wouldn't ruin my liver and I moved to Aleve (4 a day) but now I've moved to ibuprofen. It's crazy what you have to watch out for. It was very good of you to post this for us.

Ibuprofen can lead to gastrointestinal problems if you have had problems with ulcers and if you have relatively high blood pressure you may want to be careful with taking Ibuprofen regularly...Also, if taken for many years it may lead to kidney damage as well...

You may already know that.

Tater Tazz · Post by **Tater Tazz** » Wed Feb 21, 2007 5:01 pm

K.Snyder;556738 wrote: Ibuprofen can lead to gastrointestinal problems if you have had problems with ulcers and if you have relatively high blood pressure you may want to be careful with taking Ibuprofen regularly...Also, if taken for many years it may lead to kidney damage as well...

You may already know that.

Doesn't most medication over the counter and prescribed have risks? Liver and kidney? I believe they do over long period of time.

RedGlitter · Post by **RedGlitter** » Wed Feb 21, 2007 5:01 pm

What do people do for pain then??

Oh! Booze! No, just kidding. Yes, it seems like one is as bad as the next.

K.Snyder · Post by **K.Snyder** » Wed Feb 21, 2007 5:11 pm

Tater Tazz;556741 wrote: Doesn't most medication over the counter and prescribed have risks? Liver and kidney? I believe they do over long period of time.

I would have to assume that almost all drugs have their effects, especially when taken over an extended period of time, I just know that Ibuprofun heightens ones risk of ulcers and stomach bleeding for those that have problems with gastric acid.

As far as I know Acetaminophen is relatively safe for people with no liver problems as long as you don't take more than the recommended dosage...

K.Snyder · Post by **K.Snyder** » Thu Feb 22, 2007 7:16 am

Diuretic;556931 wrote: Wasn't Ibuprofen under suspicion in connection with heart disease as well?

This comment is a bit of a worry

Could it be that BigPharma is being protected?

Ibuprofen increases risk of heart attacks

From the article

In the biggest study of its kind, researchers identified 9,218 patients aged 25 and over in Scotland, England and Wales who suffered a heart attack for the first time over a four-year period. The group was tracked to see if and when they had been prescribed NSAIDS, which also include naproxen, which is found in Aleve and Naprelan; diclofenac - found in Cataflam and Voltaren; celecoxib - found in Celebrex; and rofecoxib, which is found in Vioxx and Ceoxx.

The researchers found that for those prescribed NSAIDS in the three months just before the heart attack, the risk increased compared with those who had not taken these drugs in the previous three years - for ibuprofen by 24 per cent and for diclofenac by 55 per cent. Celecoxib increased the risk of heart attack by 21 per cent, while rofecoxib increased the risk by 32 per cent.

Putting the numbers into context, researchers found that for those aged over 65 taking diclofenac, one extra patient for every 521 patients was likely to suffer a first time heart attack.

From my understanding there's a small increase in risk for heart problems when taking Ibuprofen, and even more so with people whom have had a history of heart problems, but I would have to assume that this would be the case for almost all drugs...

Experts still say that Ibuprofen is relatively safe for people who are healthy, but then again all drugs should be treated with caution.

I wouldn't be as overly concerned about that as much as I would for women who take it for over a long period of time.

Research in the Journal of the National Cancer Institute found women who took ibuprofen daily had a small but statistically significant increased risk of breast cancer compared to those who never took it.