ALEVE - Naproxen / 50 percent more likely to have heart attack or strokes, FDA warns on another pain reliever

[Guest guest]

FDA warns naproxen users

Contact doctor, avoid prolonged use

 

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

 

 

 

 

Tuesday, December 21, 2004 Posted: 12:18 PM EST (1718 GMT)

 

 

 

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."

 

CNN.com - Health Week

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Friday, December 24, 2004

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA warns on another pain reliever

The Food and Drug Administration issued a warning

to users the pain reliever naproxen, sold over the counter as Aleve

after federal researchers found an increased number of heart attacks

and strokes among users.

 

FULL STORY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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