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Despite Risks, Pain Relievers Given OK

FDA Panel Says Vioxx Can Come Back, Celebrex, Bextra Should Stay

Victory for Vioxx? continued...

But the FDA should also require strict "black box" warnings on all three Cox-2 drugs to alert patients and doctors to their risks, panel members said. A black box warning is the most serious warning placed on the labeling of a prescription medication.

Most panel members also urged the agency to use its influence with manufacturers to secure a moratorium on direct-to-consumer promotions and advertising.

FDA officials said they don't have the authority to ban the ads outright.

"I think that the committee wanted to send a very clear message that direct-to-consumer advertising for these drugs was inappropriate," panel chairman Alistair J.J. Wood, MD, told reporters following the hearing.

Warnings for Older Pain Relievers

The committee unanimously recommended that more than 20 older anti-inflammatory drugs also carry precautions of potential heart risks on their labels. It did not specify which drugs should carry the warnings or how strong they should be.

Some of the older NSAIDs, including diclofenac and Mobic, are similar chemically to Cox-2 drugs and may have to carry warnings because of limited evidence that they can influence heart attacks. Many others have never been studied to determine their potential effects on the heart.

A study among California Medicaid patients showed an increased risk of heart attack with several older anti-inflammatory drugs, including ibuprofen. That drug appeared to raise the users' risk of heart attack by 11%.

FDA scientist David Graham, MD, referred to this as "small but significant" since tens of millions of Americans use the drug regularly.

Other anti-inflammatory drugs, including indomethacin and Mobic, also appeared to raise heart attack risk by 40% to 70%, according to the study.

Graham said the data suggest that researchers must take a closer look at older anti-inflammatory drugs to learn more about their possible safety concerns.

"Clearly this is going to be a complex undertaking," panelist John Jenkins, MD, said. "Not all members of this class have the same amount of data."

Panelists warned that attaching strict warnings to Cox-2 drugs while giving weaker warnings to older anti-inflammatory drugs could be dangerous if it drove patients to take traditional drugs that may also have similar risks.

"They would have the false reassurance that there's not a problem, and we don't know that there's not a problem," he said.

Naproxen, sold under many brand names including Aleve, could end up being the only anti-inflammatory exempt from warnings because of several studies that show it causes significantly fewer heart and stroke problems than do Cox-2 drugs.

FDA experts said that previous reports linking naproxen to an increase in heart attacks were unjustified and unnecessarily scared the public.

Naproxen is better for you than the other anti-inflammatory drugs right now at least in terms of heart risk, Wood said.

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