Several weeks after the US Food and Drug Administration (FDA) announced sweeping changes to the labeling of over-the-counter (OTC) and prescription nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), the American College of Rheumatology (ACR) announced that it strongly disagrees with some of the suggested changes.

In a letter to acting FDA commissioner Lester M. Crawford, DVM, PhD, the ACR writes that "we disagree with the FDA's requirement for a black-box warning about serious cardiovascular (CV) and gastrointestinal (GI) events with over-the-counter and prescription nonselective NSAIDs as there is little evidence from prospective studies of an increase in CV events with nonselective NSAIDs and many studies show no effect or a decrease in risk for CV events with the use of nonselective NSAIDs."

"Obviously we all take drug safety seriously, but we were disappointed with the politicization of the whole process," says ACR president-elect Mary K. Crow, MD, director of rheumatology research in the autoimmunity and inflammation program at the Hospital for Special Surgery in New York City. "It's been a circus and this is not the way to send a clear message."

As a result of the recent FDA action, manufacturers of OTC NSAIDs are being asked to revise their labeling to provide more specific information about the potential CV and GI risks of their individual products and to remind patients of the limited dose and duration of treatment of these products in accordance with the package instructions.

"Unnecessary alarm"

The letter from the ACR adds that "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."

Regarding OTC NSAIDs, Dr. Crow tells CIAOMed, "our concern is that a stronger warning label will confuse the public, and it is not based on strong data at all."

"People should not have a concern about continuing to take [NSAIDs] per directions," Steven K. Galson, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in a teleconference shortly following the FDA decision. Instead, patients should consult their physicians about which painkiller is best suited for them, and to take the lowest effective dose. "All these risks we're talking about have already been known," Dr. Galson said. "People should not worry about, from today to tomorrow, stopping the products."

In addition to labeling changes, the FDA also called for the removal of valdecoxib (BextraR) from market, indicating that it has no clear advantages over celecoxib (CelebrexR). The ACR did not comment on this action in its letter.

"Clearly there were problems arising [with COX-2 inhibitors] that needed attention, but with OTC NSAIDs, the evidence is weak," says Dr. Crow, adding that the FDA should make decisions that are "data-driven after careful consideration." In a statement previously reported by CIAOMed, Dr. Galson indicated that the FDA decision was based on available data. "We think these risks apply, based on the information we have now, to all these drugs."

Going forward, well-designed studies could better elucidate the risks posed by NSAIDs, Dr. Crow says. "A lot of these drugs have been taken for decades and maybe they do have an effect on CV risk, but we will only know this through proper studies."

Rheumatologists should be more involved

Dr. Crow says that rheumatologists have not been as involved in the recent process as much as they should have or could have been. "A lot of the people who made the recent decisions don't see these patients every day, and patient concerns were not given that much weight," she says. "There is the feeling in the press that arthritis is a lifestyle condition, meaning it's just a little ache and pain, and we all know that rheumatoid arthritis, lupus, and osteoarthritis are debilitating conditions."

The full text of the ACR letter can be viewed in PDF format at: http://www.rheumatology.org/advocacy/federal/FDANSAIDletter.asp

Reference:

American College of Rheumatology. Letter to Lester M. Crawford, DVM, PhD. April 21, 2005.