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FDA: Aleve may be safer on heart than rival drugs

STUDY HALTED
WASHINGTON (AP) - Federal health officials say the pain reliever in Aleve may be safer on the heart than other popular anti-inflammatory drugs taken by millions of Americans.

A Food and Drug Administration review posted online Tuesday said naproxen - the key ingredient in Aleve and dozens of other generic pain pills - may have a lower risk of heart attack and stroke than rival medications like ibuprofen, sold as Advil and Motrin. FDA staffers recommend relabeling naproxen to emphasize its safety.

The safety review was prompted by a huge analysis published last year that looked at 350,000 patients taking various pain relievers. The findings suggest naproxen does not carry the same heart risks as other medications in the class known as nonsteroidal anti-inflammatory drugs, or NSAIDs.

The agency released its memo ahead of a public meeting next month where outside experts will discuss the new data and whether naproxen should be relabeled. The agency is not required to follow the group's advice, though it often does.

If ultimately implemented, the labeling changes could reshape the multibillion-dollar market for drugs used to treat headaches, muscle pain and arthritis.

The change could make Aleve and other naproxen drugs the first choice for patients with a higher risk for heart problems, according to Ira Loss, a pharmaceutical analyst with Washington Analysis. But he added that all NSAIDs will continue to carry warnings about internal bleeding and ulceration, a serious side effect that is blamed for more than 200,000 hospital visits every year.

The FDA meeting is the latest chapter in an ongoing safety review of NSAIDs that stretches back to 2004, when Merck & Co Inc. pulled its blockbuster pain reliever Vioxx off the market due to links to heart attack and stroke. Vioxx was part of a subset of newer NSAIDs designed to be easier on the stomach. But in the wake of the Vioxx recall, the FDA beefed up warnings about heart safety risks on all drugs in the class, including Motrin, Advil, Aleve and Celebrex. Pfizer's Celebrex is the only drug from the same class as Vioxx that remains on the market.

Current labeling warns that taking NSAIDs long-term can increase the risk of heart attack and stroke. Patients and doctors are advised to take the drugs for the shortest time period possible.

But FDA staffers said in Tuesday's memo that labeling should be changed "to reflect the more favorable cardiovascular risk profile of naproxen."

Bayer spokesman Chris Loder said in a statement that naproxen's safety and efficacy is "based on clinical trials, observational studies and clinical and real world use for more than 38 years." The German-based conglomerate is one of a half-dozen pharmaceutical manufacturers presenting at the FDA meeting, scheduled for Feb. 10 and 11.

The FDA also disclosed Tuesday that it is considering halting a long-term study comparing the safety of naproxen, ibuprofen and Celebrex, the prescription painkiller from Pfizer.

Given that recent data show a lower rate of heart attack and stroke for naproxen, FDA staffers say patients in the trial are being "exposed to an undue risk."

Launched in 2006 by Pfizer, which makes both Celebrex and Advil, the PRECISION study is expected to be completed by late 2015. The company said in a statement that "current evidence does not support" changes to the labeling of its drugs.

Celebrex was New York-based Pfizer's fourth-best-selling drug last year, with sales of $2.92 billion.

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dexrmerritt January 29 2014 at 7:42 AM

mmm...hoo paid hoo ...whom did you say....

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glers January 29 2014 at 9:01 AM

May Be Safer?

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rxjimac January 29 2014 at 12:05 PM

As a pharmacist, I have always recommended naproxyn instead of ibuprofen as an over the counter anti-infammatory / "pain reliever" . Naproxen is less irritating to the stomach lining and is longer acting in addition to having a lower effective dosage . If the lower heart risk factor is added, then it is a no-brainer. Aspirin is still an effective option and is generally less expensive, but may contribute to stomach irritaion as well. Some people need continual relief from joint disease and may take much more than the occasional headache or pain need.
The best option is to take only what you need, when you need it. RxJiMac/Atlanta

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Nuclear Mind rxjimac January 29 2014 at 12:10 PM

Doc, can naproxen act as a anti-coagulant the way aspirin is does? Can it be used with folks at risk for stroke or heart attacks the way aspirin is?

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1 reply
rxjimac Nuclear Mind January 29 2014 at 2:25 PM

There may be some anti-coagulant activity, but not to the degree aspirin is used. It should not be used that way, and not with aspirin either. It is probably O.K. to continue with the standard aspirin daily dose of 81mg's (a baby aspirin) for heart protection. Try and take the meds at different times. Aspirin &"nsaids" have the same action point in the body, so one kinda "defeats" the other.
Consult with your physician to see what regime he may recomend.

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guy January 29 2014 at 11:10 AM

been taking it every night for 40 yrs and no problems.

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loloboynton January 29 2014 at 12:30 PM

I suffer from arthritis & fibromyalgia & used Aleve for years. Aleve may be safer for the heart, but caused severe bleeding ulcers What is "good" for one body part may cause problems in other parts. These "tests" don't take that into their reports! Now I learned that the wheat & whole grains we were told to eat instead of white flour products...also have a bad side effect on our brains...good for the stomach...but "poison" for our brains...causing dementia and Altzheimer's!
Leading neurologist says gluten free diets, butter & eggs are needed or the brain dries up!

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1 reply
scorpian777 loloboynton January 29 2014 at 3:04 PM

Ever read the side effects of some drugs it reads like a novel

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feeling loved? January 29 2014 at 8:25 AM

just smoke pot for pain relief

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randallalbin January 29 2014 at 2:45 PM

also, go for store brands or generics in this. us old folks need all of these medicines. to wish for younger days when there aren't the aches and pains. good luck with this-there's alot of advertising for these choices

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oldedude January 29 2014 at 3:32 PM

take Aleve when my rheumatoid arthritis really really acts up in my knees and feet! but never more than one a day, and about three hours before bedtime so that i can get a good nights sleep. and no matter what people say,no matter what decisions a person makes, God has your days numbered all based on your actions. He knows what and when youur going to do something , like say to stop smoking, and your day is still the day you will meet Him!

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jesuaphn January 29 2014 at 10:25 AM

"May be safer"....that's reassuring!

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jdbilberry January 29 2014 at 10:01 AM

I had have heart problems and I only take alive for miner pain all the other's make me upset.

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1 reply
rxjimac jdbilberry January 29 2014 at 12:13 PM

And what mine did you work in?

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