NEWS - American College of Rheumatology opposes FDA decision on NSAIDs

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ACR opposes FDA decision on NSAIDs

Rheumawire

Apr 25, 2005

Gandey

Atlanta, GA - The American College of Rheumatology (ACR) is speaking out

against new US Food and Drug Administration rules for black-box warnings on

most nonsteroidal anti-inflammatory drugs (NSAIDs). " We disagree with the

FDA's requirement for a black-box warning about serious cardiovascular and

gastrointestinal events with over-the-counter and prescription nonselective

NSAIDs, " members of the ACR executive committee write in a letter to the

agency. " This FDA decision has caused unnecessary alarm on the part of the

public and necessitated hours of time from physicians and other healthcare

providers who must reassure and educate their patients. "

Led by ACR president Dr Tindall, the executive committee argues

that there is little evidence of an increase in cardiovascular events with

nonselective NSAIDs and many studies show no effect or a decrease in risk

for CV events with use of nonselective NSAIDs. " Much more research is needed

in this area before such strong warnings are included with these

medications, " it writes, adding that the potentially serious

gastrointestinal side effects of NSAIDs have been well known for many years.

Responding to physician concerns after a special session on COX-2 inhibitors

presented at the ACR state-of-the-art meeting earlier this month and

available online, FDA committee member Dr Hoffman (Cleveland Clinic,

OH) said, " Before we feel that the FDA has done an injustice in responding

to public pressure, my perspective is a little different. I think the FDA

has responded to the data, and I think it made a conservative and informed

decision. And the next steps, in terms of whether that's good or bad for

patients, I think we'll have to seeand our impressions really should be data

based. "

The ACR, which represents more than 6000 physicians, scientists, and

healthcare professionals, says that it is " disappointed " with the way the

FDA communicates with the public and healthcare professionals. " Patients

should be able to obtain balanced information about risks and benefits of

medications that allows them to make educated decisions. Instead,

information about the FDA's decisions concerning the risks of NSAIDs came to

the public and healthcare professionals through print and electronic media

in 'sound bites' that were often alarming, incomplete, and misleading. "

Call for new system to help clinicians prepare in advance of FDA

announcements

In their letter, Tindall and colleagues recommend a new provider-alert

system to help practitioners prepare for the onslaught of queries that

inevitably follows FDA decisions of this nature. " We understand that the FDA

is operating with a very limited budget and that it faces difficult

challenges in ensuring the efficacy and safety of an increasing number of

medications while providing the public and healthcare providers with

accurate information, " the group writes. " We propose a closer collaboration

between the FDA and practicing rheumatologists, pharmacoepidemiologists, and

basic and clinical researchers. " The executive committee points out the

potential for future ACR and FDA collaboration on issues pertaining to the

development of new antirheumatic medications.

But despite their disagreement with much of the FDA's recent action, Tindall

and colleagues applaud the decision to ask pharmaceutical companies to add a

medication guide to help patients understand the most common and serious

side effects of medications and the risk factors that predispose to those

toxicities.

After the ACR's recent special session on coxibs, physicians raised concerns

about the shifting NSAID landscape. They point out that patients are largely

unhappy with the latest developments. One doctor said that patients will

suffer now that the bar has been set higher for future NSAIDs to gain market

access.

Hoffman responded that while he shares many of the concerns expressed,

decisions have to be based on available data. " The key phrase here that I

want you to reflect on is 'our patients will suffer for it.' We don't have

any data. I mean, we're supposed to be data-driven people. We don't have any

data that our patients will suffer. We don't have any data that the use of

nonselective NSAIDs with proton pump inhibitors (PPIs), for those at risk,

not for everybody, but for people at GI risk, may not be as good as the

COX-2 inhibitors. "

To address the recent FDA decision, the ACR has updated its online patient

education information on NSAIDs.

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org