The Food and Drug Administration finalized a new label for Pfizer Inc.’s arthritis drug Celebrex, warning of increased cardiovascular risks such as heart attacks and strokes, the company said.
The “black box” warning is similar to ones that will be added to older painkillers such as ibuprofen and naproxen. The label change followed the February recommendation of an outside panel of medical experts convened by the FDA over concerns about whether drugs in the same class as Celebrex, as well as older painkillers, increased cardiovascular risks.
Celebrex is the only so-called Cox-2 drug currently for sale in the U.S. The FDA asked Pfizer to remove a similar drug, Bextra, from the market in April over safety concerns. Merck & Co. pulled its Cox-2, Vioxx, off the market in September, after clinical studies showed it raised the risks of heart attacks and strokes. Celebrex sales have fallen, down 45% to $401 million in the second quarter from a year earlier.
Celebrex’s label will recommend the drug be prescribed at the lowest dose and shortest time possible. The label also will carry a warning that Celebrex shouldn’t be used to treat pain associated with heart-bypass surgery.
“We have worked closely with the FDA to ensure that Celebrex’s label provides physicians and patients with the information they need to make the most appropriate and most informed treatment decisions,” said Joseph Feczko, Pfizer’s chief medical officer.
The company also said that the FDA approved Celebrex as a treatment for ankylosing spondylitis, a form of arthritis that affects the spine. Among other things, Celebrex is approved to treat pain associated with osteoarthritis, rheumatoid arthritis and as a treatment for familial adenomatous polyposis, a rare condition that leads to colon cancer.
Ankylosing spondylitis affects about 400,000 Americans. It typically strikes between the ages of 17 and 35, unlike most other types of arthritis that typically afflict older Americans.