Celebrex's Heart Risk Rises With High Doses
Arthritis drug stays on sale while FDA reviews findingsDec 18, 2004 | Orlando Sentinel
High doses of the best-selling arthritis medication Celebrex can more than triple a patient's risk of heart attack and stroke, the drug's maker disclosed Friday, triggering new fears about similar painkillers.
Pfizer Inc. did not announce whether it would take Celebrex off the market, but wary patients were calling their doctors for guidance.
The head of the Food and Drug Administration immediately warned patients to consult their doctors for advice and consider alternative medications.
Another arthritis medication, Vioxx, was pulled from shelves in September after it was linked to an increased risk of heart problems.
Ironically, many Vioxx users had switched to Celebrex, thinking it was a better choice.
"You think with a prescription drug you're safe, because it's been tested," said arthritis sufferer Donna Webster, 52, of DeBary, who made the change from Vioxx to Celebrex. "It makes me want to throw every [medicine] I own in the garbage can."
The dangers were discovered by the National Cancer Institute, which was using Celebrex in a study to see whether the drug prevents colon polyps. Some patients were taking 800 milligrams of Celebrex daily; others were on 400 milligrams a day; and another group was taking a placebo.
When compared with those receiving a placebo, patients on the highest dose more than tripled their risk of heart attack and stroke. The risk was more than doubled for those on 400 milligrams a day. In all, 20 people suffered heart attacks or strokes in the high-dose group compared with 15 on the lower dose and six in the placebo group.
The study has been halted, but the FDA's chief said the agency wasn't yet ready to yank Celebrex off the market.
"We just have gotten the information last evening, and we're processing it," said Dr. Lestor Crawford, acting FDA commissioner. "We do have great concerns about this product and the class of products."
The agency has come under tremendous criticism since the Vioxx problems came to light, with many questioning whether the FDA can protect the public adequately.
Crawford defended the FDA, saying it was making continual improvements in its abilities to detect problems in prescription drugs.
Celebrex and Vioxx, which is manufactured by Merck & Co., belong to a category of drugs known as COX-2 inhibitors, heralded as a breakthrough in pain control because of their lower risk of ulcers and other gastrointestinal side effects than aspirin or ibuprofen.
Some people can't tolerate those medications without suffering gastrointestinal bleeding and other dangerous complications.
"You have to wonder: What are we going to do if [Celebrex] goes?" said Doreen English, pharmacy manager for Florida Hospital. "It's really like going backward in pain therapy for arthritis."
Dr. Adam Golden, a geriatrician with Orlando Regional Medical Center's department of medical education, said he will wait for more information before taking patients off Celebrex.
He said most of his patients take 100 milligrams of Celebrex daily -- nowhere near the levels of 400 milligrams to 800 milligrams that triggered the extra risk in the study.
"It's frustrating, and I don't think we have enough information to make any blanket statements yet," Golden said. "The main point is you need to talk to your doctor. In some cases, people may not need it, and there are alternatives.
"But I hope we don't see people rushing to [other drugs] without considering the potential for other serious side effects."
Yet patients were rattled by the news, and Webster's doctor already suggested she try over-the-counter Aleve or Motrin to deal with the pain of osteoarthritis. She takes 200 milligrams of Celebrex daily.
"If it was happening with people at [higher doses], I don't know whether it's going to affect me at 200 [milligrams] or not," said Webster, who took Vioxx for four years before it was taken off the market. "But I'm not willing to take that chance."
Experts think there will be serious fallout from the new discovery.
Pfizer suffered heavily in the market Friday, with shares plunging $3.30, or 11.4 percent, to $25.68 in late-afternoon trading on the New York Stock Exchange. The decline wiped out more than $25 billion of Pfizer's market value.
The New York Times reported an estimated 2.34 million prescriptions were written for Celebrex in October the first month after Vioxx was recalled. That was up from 2 million in September.
The withdrawal of Vioxx was a financial and public-relations disaster for Merck. Its legal liabilities are estimated at up to $18 billion, and its shares have dropped by nearly one-third since the recall announcement in late September.
Vioxx had been a blockbuster drug for Merck and was its No. 2 earner, with annual global sales of $2.5 billion 11 percent of the company's $22.5 billion in revenue last year.
Earlier this month, the FDA said it was adding a warning to labels of another COX-2 inhibitor, Bextra, noting a risk of heart problems in people who have had recent bypass surgery.