Naproxen Warning Unjustified, Say FDA Experts
Report Linking Aleve to Heart Attacks Unnecessarily Scared Public
Feb. 18, 2005 - A report last year that linked the pain killer naproxen to
heart attacks unnecessarily scared the public, experts charged Friday.
FDA advisory panel members reviewing the safety of the arthritis drug Vioxx
and similar drugs accused National Institutes of Health officials of acting
irresponsibly when they stopped a study testing the drugs Naproxen is sold under
many brand names, including Aleve and Naprosyn.
The NIH halted the trial, called ADAPT, after data suggested that naproxen
raised the risk of heart attack and stroke in study patients.
An earlier study showed that Celebrex had similar risks.
NIH Director Elias A. Zerhouni, MD, released a statement saying that the
trial was being stopped "as a precautionary measure to ensure the safety of
the study's participants" and that the researchers made their decision
based on the risk/benefit analysis specific to this trial.
But one ADAPT researcher told the panel Friday that naproxen's effect on
heart risk was "barely significant" and that the study was not stopped
because of safety concerns. Instead, officials halted the trial because of a
concern that questions on the safety of
and related drugs would
make study participants reluctant to take their medications and damage the
integrity of the study.
"There seemed little practical choice but to do so," said
Constantine Lyketsos, MD, a Johns Hopkins University researcher who was part of
the ADAPT study team. Some study patients had already begun to resist taking
their drugs, and study directors became fearful that patients would "vote
with their feet" and stop participating altogether.
"We feared further erosion" of the study, he said.
Lyketsos also said that study leaders faced an ethical dilemma of continuing
with an Alzheimer's prevention study with no expected immediate benefit to
patients, given possible safety concerns with Celebrex, Vioxx, and similar
drugs, called Cox-2 inhibitors.
FDA experts harshly criticized the NIH's announcement, saying that it
potentially scared millions of naproxen patients despite some pervious data
suggesting that the drug may actually be safer for the heart than Cox-2
Studies have suggested that naproxen may carry a lower heart risk than Cox-2
drugs, but researchers remain unsure of its heart safety since it has never
been tested against a placebo.
The announcement "had the effect that was the equivalent of screaming
'fire' in a crowded auditorium," said Steven Nissen, MD, a panel member and
medical director of The Cleveland Clinic.
Nissen said he and other cardiologists were forced to field calls from
hundreds of frightened patients who had read media reports of naproxen's
"It caused a panic that was unnecessary, and it shouldn't have happened,
and I hope it doesn't happen again," said Nissen. "We can't do business