Pfizer CEO defends Celebrex, will not recall drug
December 19, 2004 17:11

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: Pfizer WASHINGTON, Dec 19 (Reuters) - Pfizer Chief Executive Hank McKinnell said on Sunday doctors should be made aware of the health risks in prescribing Celebrex to their patients,... (Read Celebrex Article)

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: FDA The U.S. Food and Drug Administration is advising doctors to consider alternatives to pain reliever Celebrex in the wake of a study that showed it increased the risk of heart... (Read Celebrex Article)

One long-term cancer study found high doses (400mg - 800mg) of Celebrex over time more than doubled the risk of heart attack, but a second study found no increased risk at all. Celebrex was approved in 1998 by the Food and Drug Administration for doses of 100mg or 200mg. http://www.wistv.com/Global/story.asp?S=2707547

With yet more already-marketed medicines raising the ire of consumer advocates and regulators alike, momentum is building for reform of the government's drug approval and monitoring procedures. http://newstandardnews.net/content/index.cfm/items/1339

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: Celebrex Recall The agency could ask Pfizer to pull Celebrex from the market. Pfizer said Friday it had no plans to recall the drug. Crawford said the FDA would have more announcements... (Read Celebrex Article)

Continued risk for Celebrex users http://www.wndu.com/news/122004/news_39110.php

Pfizer Inc. has halted new research on its popular pain drug Celebrex after finding an apparent increased risk of heart attacks in cancer patients.

The company announcement, made Friday morning, said a second, separate cancer trial found no increased risk of heart problems tied to the drug. But Pfizer urged that all patients "being treated with Celebrex should discuss appropriate treatment options with their health-care professionals."

"In placing this new information in context, it is important to understand that the APC trial results differ from both the PreSAP cardiovascular results as well as the large body of data that we and others have accumulated over time, in which an increased risk of serious cardiovascular events in arthritis patients, even at higher-than-recommended doses, had not been seen," said Dr. Joseph Feczko, president of worldwide development for Pfizer.

Dr. James O'Dell, chief of rheumatology and immunology at the University of Nebraska Medical Center, said the Celebrex concerns stem from experimental uses of the drug at doses two to four times the 200 mg or less daily dose recommended for most patients.

"We have a vast amount of data on Celebrex that's been accumulated from double-blind clinical studies and very large observational studies that have looked very closely at the heart," said O'Dell, a nationally recognized rheumatoid arthritis expert.

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: 800mg Celebrex The company said it has no plans to remove Celebrex from the market, but the disclosure on Friday sent Pfizer's shares tumbling because of fears that it could cripple... (Read Celebrex Article)

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: ________

Celebrex is used by 26 million people, according to Pfizer, and is the latest COX-2 type pain drug to face controversy. Vioxx, made by the rival Merck and Co., was withdrawn in September because of the increased risk of heart attacks.

Three US doctors on Friday appealed for physicians to stop prescribing Bextra, another COX-2 painkiller, also made by Pfizer.

News of the Celebrex study sent Pfizer shares slumping but the US firm's chairman Hank McKinnell said the drug would not be withdrawn.

"Any decision to withdraw a drug has to be made in the context of all of the information," McKinnell told CNBC television.

"Until the study results became known to us late last night we saw a very acceptable safety profile for Celebrex."

"I don't think this one study, even though it is a large, well-controlled study, characterizes the drug in any significant way," McKinnell said.

A study into the use of Celebrex to prevent benign tumours, or adenomas, showed patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5-fold increased risk of major cardiovascular problem compared to patients on a placebo, according to the National Cancer Institute (news - web sites).

Based on the "statistically significant" findings, the institute, which sponsored the trial, suspended the dosing of Celebrex. The news was given to Pfizer late Thursday.

A separate study into whether Celebrex can prevent polyps showed no increased risk to the heart.

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

"We're leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," said Crawford, during a press briefing. "We do have great concern about this product (Celebrex) and the class of products."

"Let's hope that Pfizer isn't falling into the same mind-set that Merck demonstrated when it stonewalled for years over the safety of its popular arthritis drug, Vioxx, only to yank it from the market when a convincing study found it raised the risk of cardiovascular problems. Yesterday Pfizer announced the results of a government-sponsored clinical trial, which showed that its own best-selling arthritis drug, Celebrex, more than doubled or tripled the risk of heart attacks, strokes and cardiovascular deaths, depending on the dosage" says a NY Times editorial.

It is all about profits. The editorial goes on to say, "Pfizer said it would not pull Celebrex off the shelves, a stance that is not surprising given the profits generated by the drug, and the widespread belief in the industry that Merck only compounded its legal and financial problems by withdrawing Vioxx. But if Vioxx was risky enough for Merck to remove from the market, one wonders why Celebrex should not be yanked as well."

Let me know what you think.

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC