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To: Neeka who wrote (91696)12/21/2004 2:11:58 AM
From: Neeka  Respond to of 793843
 
Oh dear, here's another warning for a common drug.

I'm nowhere near 70, and I don't have a family history of Alzheimer's disease, but I've been taking two Aleve every morning for three years for a herniated disk between L4-L5.

M

FDA warns on generic drug naproxen
By Carolyn Pritchard, CBS MarketWatch.com
Last Update: 9:21 PM ET Dec. 20, 2004


SAN FRANCISCO (CBS.MW) -- The U.S. Food and Drug Administration issued a warning about the generic drug naproxen late Monday after the National Institutes of Health halted a clinical trial involving patients at risk of developing Alzheimer's Disease.







Naproxen, a non-steroidal, anti-inflammatory drug, is sold under a variety of brand names, including Aleve, from Bayer (BAY: news, chart, profile); and Naprosyn, from Roche (RHHBY: news, chart, profile).

The NIH suspended until further notice the use of both naproxen and the COX-2 inhibitor celecoxib, marketed by Pfizer (PFE: news, chart, profile) as Celebrex, in a large, three-arm, national Alzheimer's disease prevention trial.

The trial was designed to assess the potential long-term use of the two drugs in decreasing the risk of developing Alzheimer's disease in people 70 years of age or older who were considered to be at increased risk because of family history, but did not have symptoms of the disease.

Preliminary information from the study showed some evidence of increased risk of cardiovascular and cerebrovascular events in patients taking naproxen vs. a placebo, the NIH reported.

Patients taking over-the-counter naproxen should carefully follow the label instructions and should not take the naproxen for longer than 10 days, the FDA warned.

No significant risk was found in the trial for patients taking celecoxib, according to the NIH, but the use of these drugs in the study was suspended in part because of findings reported last week from a National Cancer Institute trial to test the effectiveness of celecoxib in preventing colon cancer.

On Friday, drug giant Pfizer said a long-term study of Celebrex linked the drug when administered in high doses to an increased risk of heart attacks. The company has decided to halt all advertising for the drug.

Merck (MRK: news, chart, profile) withdrew its arthritis drug Vioxx from the market in late September after a clinical trial linked long-term usage to an increased incidence of heart attack and stroke.

Naproxen first was sold as a prescription drug under the trade name Naprosyn in 1976. The FDA approved its use as an over-the-counter drug in 1994.


Carolyn Pritchard is a reporter for CBS.MarketWatch.com in San Francisco.


cbs.marketwatch.com