April 25, 201812:03 PM ET
Updated at 1:54 p.m.
A prescription painkiller that has been under a cloud for more
than a decade is apparently safer than previously believed, a Food and Drug
Administration panel concluded Wednesday.
The drug celecoxib, which is sold by Pfizer under the brand
name Celebrex,
poses no greater risk for causing heart attacks and strokes than two other
widely used pain relievers, the committee voted at the end of a two-day hearing.
The vote was 15-5. One member abstained.
Based on the committee's conclusion, the FDA may change the
advice about the drug's safety that it provides to doctors. The FDA doesn't
have to follow the advice of advisory committees advice but usually does.
The availability and safety of alternatives to opioid
painkillers have become increasingly important as the nation grapples with the
deadly epidemic.
For more than a decade, some doctors have been reluctant to
prescribe celecoxib, which isn't an opioid, because it is similar to Vioxx, a pain reliever that was withdrawn from the
market in 2004 because of safety concerns. Both drugs are known as COX-2
inhibitors because they act by blocking an enzyme involved in inflammation.
After Vioxx was launched in 1999, it quickly became a
blockbuster and was used by millions of people. It was designed to cause fewer
gastrointestinal complications than existing pain relievers. But Vioxx was
pulled from the market in 2004 after being linked to heart attacks and strokes.
A similar drug, called Bextra, was pulled from the market in 2005. The FDA
allowed Celebrex to remain on the market but ordered Pfizer to conduct a large
study to examine the drug's safety. The medicine has since become available in
generic forms.
The FDA's committee's conclusion is based on the results of
that study, which involved more than 24,000 patients
with osteoarthritis and rheumatoid arthritis. One-third took celecoxib, which
is only available by prescription. One-third took prescription doses of ibuprofen. The remaining third took prescription naproxen.
The study found no evidence that celecoxib poses any greater
risk for causing heart attacks and strokes than ibuprofen or naproxen. Those
medications are in category known as nonsteroidal anti-inflammatory drugs,
or NSAIDs.
Many of the committee members stressed that celecoxib isn't
completely safe. The study showed it can increase the chance of cardiovascular
complications. But celecoxib doesn't appear to boost those odds nearly as much
as Vioxx did, or apparently even as much as prescription doses of ibuprofen and
naproxen, which were thought to be safer.
The study found the risk of dying, suffering a stroke or having
a heart attack among patients taking celecoxib was 2.3 percent during a
30-month period, compared with 2.5 percent for naproxen and 2.7 percent for
ibuprofen
In fact, celecoxib was less likely to cause certain
complications, such as gastrointestinal problems like ulcers and bleeding, as
well as kidney problems such as kidney failure and the need for dialysis,
according to the study. Some committee members questioned the significance of
these findings, and the committee didn't take a specific vote on these results.
Ibuprofen is sold over the counter in much lower doses as a
generic and under a variety of brand names, including Advil and Motrin.
Naproxen, also generic, is sold over the counter with various names, like Aleve
and Naprosyn.
The maximum recommended over-the-counter dose of ibuprofen is
typically 1,200 milligrams daily. The study used 600 milligrams of ibuprofen
three times a day, or 1,800 milligrams daily. Naproxen tablets are sold over
the counter at a dose of 220 milligrams and are taken twice a day. The study
used doses between 375 and 500 milligrams taken twice a day.
The committee considered whether nonprescription doses of
ibuprofen and naproxen can interfere with the ability of low-dose aspirin to
protect people against heart attacks. Millions of people take low doses of
aspirin daily to reduce their risk of having a heart attack.
The committee voted 12-7, with one member abstaining, in favor
or warning patients taking aspirin about the possible risk of taking naproxen
at the same time. Ibuprofen also carries a warning like that, and the committee
voted 17-4 against adding any additional warnings.
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