Even as the painkiller Celebrex heads for its first product-liability trial, the drug is making a comeback of sorts for its maker, Pfizer Inc.
The New York drug giant says worldwide annual Celebrex sales this year should surpass $2 billion, a growth trend in sharp contrast to the huge loss in sales that the prescription for pain relief from arthritis experienced last year.
Worldwide Celebrex sales plummeted 48 percent last year, to $1.73 billion from $3.3 billion in 2004. Celebrex’s downward spiral came after it was linked in late 2004 to increased risks of heart attacks and strokes, like the only other two drugs of the same type on the market—so-called Cox-2 drugs Vioxx and Bextra.
A year ago some doctors on an FDA advisory panel said all three drugs increased heart risks as part of a “class effect” for Cox-2 drugs. The panelists’ statements and other safety risks linked to Vioxx and Bextra hurt Celebrex sales.
But Pfizer and industry analysts say Celebrex has since fared better with regulators around the world than Vioxx, which is made by Merck & Co., and Bextra, which is also a Pfizer product. FDA staffers last month said Bextra should be kept off the market permanently due to side effects that include a rare, potentially fatal skin disorder.
Meanwhile, Vioxx has been dogged by more than 9,000 lawsuits linking the drug to increased risks of heart attacks and strokes. Merck pulled Vioxx from the market in September 2004 but has not ruled out putting it back on the market. A year ago an FDA advisory panel narrowly voted to recommend that Vioxx be allowed back on the market.
“Celebrex continues to be available as an important treatment option for patients,” Pfizer spokesman Paul Fitzhenry said.
“The FDA, the [European regulatory agency] and other health authorities have concluded that the benefits of Celebrex continue to outweigh its risks, and, as a result, Celebrex is the only Cox-2 inhibitor remaining on the market today,” Fitzhenry said.
Despite the regulatory endorsements, plaintiffs’ lawyers are forging ahead with lawsuits on behalf of patients who believe Celebrex caused heart attacks, strokes or other cardiovascular problems.
What is believed to be the first of the Celebrex trials has been set for June 6 in the Circuit Court of Barbour County in Alabama. Rosie Ware, 54, of Clayton, Ala., alleges that the Celebrex she took to relieve joint pain associated with osteoarthritis caused her to have a stroke in February 2005.
The suit names Pfizer, Pharmacia Corp., which Pfizer bought in 2003, and the now shuttered G.D. Searle, the Skokie-based drugmaker that developed Celebrex and launched the drug in the late 1990s.
“It will most likely be the first Celebrex case to be tried in the country,” Montgomery, Ala.-based law firm Beasley Allen, which is representing Ware, said in a statement.
Pfizer had no comment on the Ware case.