Lawmaker calls for FDA review amid drug safety troubles
December 21, 2004 07:44

"It seems the time has come for a comprehensive review of drug safety and of how federal government agencies oversee drug research and approve, license and regulate drugs," said Senator Chuck Grassley, chair of the Senate finance committee, which oversees the FDA.

"Today, Pfizer released information about an increased risk of heart attack for its drug Celebrex, and Eli Lilly issued a new warning about liver problems with the drug Strattera. The last year revealed serious problems involving children and anti-depressants, painkillers like Vioxx, Bextra and Celebrex, the flu vaccine, and the AIDS (news - web sites) drug nevirapine," Grassley said Friday. "At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us."

Pfizer's chairman Hank McKinnell said the drug would not be withdrawn.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.

McKinnell said: "These clinical trial results are new. The cardiovascular findings in one of the studies are unexpected and not consistent with the reported findings in the second study.... Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world."

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

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

But many lawyers, even those who have sued Merck on behalf of patients who took Vioxx, said yesterday that there are clear-cut differences. The case against Pfizer does not appear as strong at this point, they said, because major clinical studies suggest that Celebrex does not pose as great a risk as Vioxx. Nor have any documents yet emerged, as they did at Merck, suggesting that Pfizer had doubts about its drug.

Pfizer said yesterday that it continued to believe that Celebrex, which has been prescribed for more than 26 million patients, is safe and that it had no plans to stop selling the drug.

It is unclear how many Celebrex cases had already been filed, even before yesterday's announcement. Pfizer puts the number at 24, but Beasley Allen, a law firm in Montgomery, Ala., said it alone has 53 cases filed.

Consumer advocates and some doctors have been arguing that the COX-2 drugs not only pose greater health risks than the manufacturers have said but that their therapeutic benefits in comparison with much cheaper over-the-counter painkillers have been exaggerated.

http://www.nytimes.com/2004/12/18/business/18pfizer.html?ei=5006&en=01e63f8fb05cf86f&ex=1104037200&adxnnl=1&partner=ALTAVISTA1&adxnnlx=1103633327-x46hiC4YESw4P4jjgD1PGg

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

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

US drug giant Pfizer said Friday that a trial had found a sharp rise in heart attacks for patients using Celebrex, its arthritis and pain medicine, but that it would not immediately withdraw the treatment.

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 increased risk of heart attacks.

Separately, three US doctors on Friday appealed for physicians to stop prescribing Bextra, another COX-2 painkiller by Pfizer, for the same reason.

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

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

US drug giant Pfizer said a trial had found a sharp rise in heart attacks for patients using its blockbuster Celebrex arthritis and pain medicine but it would not immediately withdraw the treatment.  

On December 17th, Pfizer announced it found an increased risk of heart problems with patients taking its pain killer, Celebrex. This drug is in the same class as Vioxx, which was pulled from the market in September. Similar safety issues have been raised regarding Pfizer's Bextra, another Cox-II inhibitor. The Beasley Allen Law firm is a national leader in Cox-II litigation and has been for over three years.

Contact:  Andy Birchfield, Attorney
BEASLEY, ALLEN, CROW, andy.birchfield@beasleyallen.com

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: 200mg Celebrex

According to a clinical trial conducted by the National Cancer Institute (NCI) and Pfizer, Inc., patients taking 400 mg of the drug twice daily had a 3.4 times greater risk of cardiovascular events compared to placebo. For patients in the trial taking 200 mg. twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

These findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class. Vioxx was recently voluntarily recalled by Merckin September. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for CV events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market.

While Pfizer announced today that it would halt advertising of the drug, it appears they had little choice in that decision. The Food and Drug Administration said on Friday that it was considering regulatory measures that could include severe label warnings or even requiring that the drug be withdrawn in the United States.

"Pfizer will inevitably have to recall Celebrex," Mr. Methvin said, "and I believe they are making a careless decision in not doing so immediately."

Andy Birchfield, Beasley Allen's lead Celebrex Litigation attorney, is spearheading the review of 383 cases, having filed 53 of those cases against Pfizer dating back to 2000.

For more information visit the Celebrex Legal Resource Site or contact:

Andy Birchfield, Attorney Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. 1-800-898-2034 toll free 1-334-954-7555 fax andy.birchfield@beasleyallen.com

Online Media Contact: Jayme Yarroch 1-800-898-2343 toll free jayme.yarroch@beasleyallen.com Beasley Allen Law Firm Celebrex Lawsuit Information

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

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

LITTLE ROCK, Ark. -(Dow Jones)- An Arkansas law firm filed suit charging Pfizer Inc. (PFE) with misrepresenting the potential dangers of its arthritis drug Celebrex.

The pharmaceutical giant, which removed all Celebrex advertising as of Monday, now faces at least three shareholder lawsuits. Two were filed Friday when Pfizer first disclosed its Celebrex and Bextra products may increase the chances of heart problems in users.

In a press release Tuesday, law firm Emerson Poynter LLP said it filed the suit on behalf of shareholders who purchased Pfizer stock between Nov. 1, 2000, and Dec. 16 of this year.

Emerson Poynter pointed to statements Pfizer made in November touting Celebrex as a safe alternative to similar anti-inflammatory drug Vioxx. Merck & Co. (MRK) voluntarily withdrew Vioxx from the market in September after users similarly showed a higher risk of heart attack.

Last week, Pfizer released a five-year cancer study which found that taking Celebrex more than doubled the chance users would develop a major heart problem.

Additionally, Emerson Poynter is investigating possible violations of the Employee Retirement Income Security Act of 1974.

A Pfizer representative wasn't immediately available for comment.

DOW JONES

ARTHRITIS DRUG RAISES HEART-ATTACK CONCERNS

The future of Celebrex, the best-selling arthritis pain medicine, may be determined as much by Dr. Jason Faller and other doctors treating arthritis patients as by federal regulators.

``Certainly I will be disinclined to start patients anew on the drugs,'' Faller said. Still, he said Celebrex and Bextra, a similar arthritis drug also made by Pfizer that has also raised heart attack concerns, provide useful alternatives for some patients who are not helped by older over-the-counter drugs like ibuprofen, the generic name for Advil.

Both Celebrex and Vioxx, a similar medicine which Merck stopped selling in September after it was also linked to heart attacks, are generally no more effective than over-the-counter medicines, said Dr. Marcia Angell, the former But Dr. Gail Cawkwell, who directs Pfizer's medical research on Celebrex and Bextra, said many patients benefited from the drugs. ``Celebrex still has some significant benefits over the older medicines,'' she said. ``We've had a lot of support from doctors saying they have patients who haven't responded to anything else.''

Pfizer officials on Sunday said that they have agreed to an FDA request to suspend all direct-to-consumer advertisements for Celebrex but will not remove the medication from the market. FDA acting Commissioner Lester Crawford said that physicians should consider alternatives to Celebrex, a COX-2 inhibitor taken by 27 million patients worldwide since 1998.

FDA officials, who also asked Pfizer officials to revise how the company markets Celebrex to physicians, said that it could take other actions related to the medication in the near future. Celebrex is similar to the COX-2 inhibitor Vioxx, which Merck in late September withdrew from the market because of safety concerns.

Most attorneys agree that lawsuits against Merck over Vioxx are "much stronger" than the expected cases against Pfizer over Celebrex, but additional negative information on Celebrex "would translate into a much greater liability problem," the Journal reports. In the event that FDA does not remove Celebrex from the market, Pfizer likely would face limited liability because "a drug still approved for sale on the market makes it much more difficult to prove in a court of law that it is unsafe," the Journal reports.

A Pfizer spokesperson said, "Product liability concerns don't dictate our decision making. Rather, it's the health and well-being of patients along with the guidance that we receive from the FDA that inform our decisions." Joseph Capobianco, a partner with Reisman Peirez & Reisman, said, "From a liability and lawsuit view, my advice would be to pull the drug off the market. That's the safest course." Paul Rheingold, an attorney who plans to file Celebrex lawsuits, said that the decision by Pfizer to suspend DTC ads for Celebrex indicates the company is "admitting something."

Rheingold added, "What are they saying, 'It's only half dangerous'? It's certainly encouraged us to get going on these cases." Paul Argenti, a professor at the Tuck School of Business at Dartmouth College, said, "If their strategy is to minimize legal ramifications by keeping the product on the market, that's a short-term gain that will have long-term repercussions," adding that patients "see these drug companies are taking advantage of people with expensive advertising and then trying to rationalize about things that are emotional -- like the sense of danger. Pfizer will be lumped together with Merck" (Wall Street Journal, 12/21).

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

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

The future of Celebrex, the best-selling arthritis pain medicine, may be determined as much by Dr. Jason Faller and other physicians treating arthritis patients as federal regulators.

"Certainly I will be disinclined to start patients anew on the drugs," Dr. Faller said. Still, he said Celebrex and Bextra, a similar arthritis drug also made by Pfizer which has also raised heart attack concerns, provide a useful alternative for some patients who are not helped by older over-the-counter drugs like ibuprofen, the generic name for Advil.

Both Celebrex and Vioxx, a similar medicine which Merck stopped selling in September after it was linked to heart attacks, are generally no more effective than over-the-counter medicines, said Dr. Marcia Angell, the former editor of The New England Journal of Medicine. "There was never much reason for these drugs in the first place," she said. "So one should accept virtually zero side effects from these drugs."

NY TIMES

Montgomery, AL (PRWEB) December 21, 2004 -- Tom Methvin, managing shareholder at Beasley Allen Law Firm , has called upon Pfizer to recall Celebrex . "Our firm has been watching the situation unfold over the past 4 years. In light of the recent findings which undeniably link Celebrex to greater heart-attack risks, it is time for Pfizer to act responsibly and pull the drug from the market," said Mr. Methvin at a recent press conference.

According to a clinical trial conducted by the National Cancer Institute (news - web sites) (NCI) and Pfizer, Inc., patients taking 400 mg of the drug twice daily had a 3.4 times greater risk of cardiovascular events compared to placebo. For patients in the trial taking 200 mg. twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

These findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class. Vioxx was recently voluntarily recalled by Merck in September. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for CV events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market.

While Pfizer announced today that it would halt advertising of the drug, it appears they had little choice in that decision. The Food and Drug Administration (news - web sites) said on Friday that it was considering regulatory measures that could include severe label warnings or even requiring that the drug be withdrawn in the United States.

"Pfizer will inevitably have to recall Celebrex," Mr. Methvin said, "and I believe they are making a careless decision in not doing so immediately."

Andy Birchfield, Beasley Allen"s lead Celebrex Litigation attorney , is spearheading the review of 383 cases, having filed 53 of those cases against Pfizer dating back to 2000.

For more information: Andy Birchfield, Attorney Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. 1-800-898-2034 toll free 1-334-954-7555 fax andy.birchfield@beasleyallen.com

Online Media Contact: Jayme Yarroch 1-800-898-2343 toll free 1-334-657-8959 mobile jayme.yarroch@beasleyallen.com Beasley Allen Law Firm Celebrex Lawsuit Information