Drug Lawsuit news

Pfizer looking to put Bextra back on market

By Diedtra Henderson, Globe Staff | May 12, 2005
WASHINGTON -- Pfizer Inc. wants to puts its painkiller Bextra back on the market.

Chief executive Hank McKinnell said yesterday that Pfizer pulled Bextra last month ''in deference" to the Food and Drug Administration, but ''we believe there is an important place for this drug in the treatment of arthritis and rheumatism. We are hoping to be able to work with the FDA to find a way to make that option available."

McKinnell said ''increased cardiovascular risk" did not play a role in the FDA's request that the company stop selling Bextra, which was approved to treat arthritis and menstrual pain.

''They did see a skin reaction, which is already in the label," he said.

McKinnell's statements contradicted the FDA.

In a 19-page memo issued April 6, the FDA explained why it is adding its sternest warning to the label for Pfizer's Celebrex and why it recommended halting Bextra sales.

The FDA said Bextra, Celebrex, and Vioxx -- removed from the market in September by Merck & Co. -- were associated with ''an increased risk of serious adverse" cardiovascular side effects. In addition, the agency linked Bextra to unpredictable skin reactions. The FDA said it has received at least seven reports of people dying from severe skin reactions after using Bextra.

The agency said it would ''remain open" to limited Bextra use if patients sign consent forms.

One analyst who follows Pfizer said that, given the risks associated with Bextra, he doubts doctors would prescribe the drug. Michael Obuchowski, a principal with Altanes Investments LLC, said McKinnell's comments may have been part of the company's legal strategy. Yesterday, lawyers met in Chicago to plan for an anticipated wave of Bextra and Celebrex lawsuits.

If the FDA agreed that Bextra should be returned to the market, Obuchowski said, ''it would probably be more difficult for the litigation to succeed."

Thomas M. Sobol, a Cambridge lawyer who is among dozens filing Bextra lawsuits, said ''some drug companies argue that because their product is legally on the market that, for personal injury cases, the product itself cannot be treated as defective."

Obuchowski said that even if Bextra were prescribed less frequently, it would generate much-needed revenue for Pfizer, provided it does not require additional major expense. The company's annual growth dropped from 28 percent in 2001 to an expected negative 7 percent earnings per share in 2005.

Federal advisers have said they want companies that make the troubled painkillers to demonstrate their safety with large clinical trials -- which can cost millions of dollars -- before the FDA returns products to the market or removes recently-added warnings.

Pfizer recorded charges totaling $1.21 billion in the first quarter of 2005 due to the suspension of Bextra sales.

During recent congressional testimony, a Merck representative said that the company is in talks with the FDA about returning Vioxx to the market. The FDA has said it will carefully review such a proposal and would schedule public and private advisory meetings before making a final decision.

Bextra, Celebrex, and Vioxx, considered designer painkillers, were sold as new ways to relieve pain without causing ulcers associated with older drugs. Sales soared, pushed by aggressive advertising campaigns.

In 2004, sales of Celebrex rose to $2.75 billion, compared with $1.25 billion for Bextra. Vioxx, sold only from January through September, amassed $1.34 billion in sales, according to IMS Health.

Vioxx's high-profile withdrawal has prompted closer scrutiny from Congress of drug manufacturers and the FDA. A flurry of new bills seek to improve drug safety and extract more information from manufacturers about drug risks. Legislation proposed by Representative Pete Stark of California, the ranking Democrat on the Ways and Means health subcommittee, would fine chief executives up to $2 million for knowingly concealing information about serious drug side effects

Lawyers Preparing for Bextra Lawsuits

In April 2005, Pfizer withdrew Bextra from the market after the FDA asked the pharmaceutical maker to pull the painkiller because the risk of a serious cardiovascular event outweighed Bextra's potential benefit. The FDA also asked Pfizer to include a black boxed warning, the most serious warning a medication can receive, in the Celebrex label. The government is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular events and gastrointestinal bleeding with their use.

Pfizer Takes Bextra Off The Market - Drug Lawsuit News

WASHINGTON Apr 7, 2005 — The painkiller Bextra was taken off the market Thursday, and the government wants other drugs in the same class to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.

Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators. The company said that the FDA, in seeking Bextra's withdrawal, cited a risk of serious skin reactions to Bextra on top of the risks shared by other similar drugs.

The boxed warning recommended for the other non-steroidal anti-inflammatory prescription drugs is the strongest available to the FDA.

In addition to the prescription drugs, the FDA asked manufacturers of related over-the-counter painkillers to revise their labels to include information about the risks of cardiovascular incidents and gastrointestinal bleeding.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," said Dr. Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research.

The risks posed by Bextra outweigh its benefits, the FDA said.

The FDA has been studying the safety of the so-called Cox-2 inhibiters since Merck & Co. voluntarily pulled Vioxx from the market Sept. 30 after heart problems were reported in some users. Once blockbuster sellers, the painkillers were particularly popular among arthritis sufferers.

"For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," Pfizer said in a statement Thursday.

Pfizer said it planned further discussions with the FDA about the possibility of returning Bextra to the market.

"Pfizer respectfully disagrees with FDA's position regarding the overall risk-benefit profile of Bextra," the company said.

Pfizer shares fell about 3 percent soon after Thursday's opening bell on the New York Stock Exchange.

Merck Says Vioxx Risks May Apply to Whole Drug Class

Feb. 16 (Bloomberg) -- Merck & Co. told U.S. Food and Drug Administration advisers today that research linking its withdrawn Vioxx to heart attacks and strokes may apply to the entire class of painkillers known as Cox-2 inhibitors.

Merck's testimony came on the first day of a three-day hearing in Gaithersburg, Maryland in which FDA advisers are examining whether the risks of Cox-2 drugs such as Pfizer Inc.'s Celebrex and Bextra outweigh their benefits. The panel will make a recommendation at the end of the hearing that could range from calling for the drugs' withdrawal to stronger safety warnings.

``We believe the data strongly suggest a class effect from Cox-2 inhibitors,'' said Ned Braunstein, senior director of Merck's research labs, whose voice grew hoarse during his testimony before a standing-room-only crowd. ``We would argue that long-term studies are needed'' to determine class effects.

Pfizer, also scheduled to testify today, has argued its drugs don't carry the same risks as Vioxx. At stake is the more than $4 billion in sales New York-based Pfizer generated from Celebrex and Bextra, part of a class of drugs once thought to be more effective than anti-inflammatory medicines such as aspirin and ibuprofen and easier on the stomach.

Pfizer excluded outside Celebrex data

By Carla Mozee, (see MarketWatch for full article)
Last Update: 4:40 PM ET Feb. 5, 2005  

SAN FRANCISCO (MarketWatch) - A Pfizer official said analysis of its arthritis and pain drug Celebrex that the company submitted to federal officials did not include studies by independent researchers or other drugmakers indicating that Celebrex raised the risk of heart problems, the New York Times reported Saturday.

The Times said Dr. Joseph Feczko, Pfizer's president for worldwide development, said in an interview that a few studies conducted by outside parties found increased heart risks for patients taking Celebrex and Bextra.

A Pfizer-sponsored trial of Alzheimer's patients in 1999 found the increased risk. Pfizer never published the results of the trial, said the Times.

It also said the National Institutes of Health ended a study two months ago after discovering high doses of Celebrex more than tripled the incidence of heart attacks and strokes.

Feczko said of the two trials, "they are what they are," according to the Times. But "the overwhelming preponderance of evidence" indicates Celebrex and Bextra are safe, Feczko told the Times.

Feczko told the Times that Pfizer had conducted much less research on Bextra than on Celebrex because it felt Bextra was similar to Celebrex.

COX-2 is a class of non-steroidal anti-inflammatory drugs used primarily to treat chronic pain from osteoarthritis and rheumatoid arthritis.

Bextra filing faces FDA scrutiny

By NICOLE OSTROW BLOOMBERG NEWS

NEW YORK - Pfizer Inc. has asked U.S. regulators to approve the intravenous form of its Bextra painkiller, which in pill form has been linked to an increased risk of heart attacks in some patients.

The application for parecoxib was filed with the U.S. Food and Drug Administration in mid-December, Pfizer spokeswoman Susan Bro said Thursday. The FDA usually aims to complete its review of applications within 10 months.

Hank McKinnell, chief executive officer of New York-based Pfizer, is seeking approval for parecoxib as regulators prepare to weigh the safety of Cox-2 painkillers such as Bextra at a February hearing in Washington. Pfizer's other Cox-2 drug, Celebrex, was linked to heart risks in high doses in studies released this month, while Merck & Co. recalled Vioxx Sept. 30 for similar reasons.

"The FDA is going to be very carefully scrutinizing any new applications in the Cox-2 arena," said Steve Lampe, who helps manage $8 billion in assets at Delaware Investments in Philadelphia.

The FDA doesn't comment on applications under review. But last week, the agency urged doctors to limit prescriptions of Bextra and Celebrex before the February meeting. Bextra is one of five drugs that FDA reviewer David Graham identified as unsafe at a Nov. 18 Senate hearing.

Parecoxib, available in more than 45 countries, differs from the pill form of Bextra in that it is meant for short-term use and is given either intravenously or as a shot into a muscle after surgery. The company told investors at a Nov. 30 meeting that it planned to file the parecoxib application by the end of the year.

This month, Pfizer said it would warn doctors that Bextra is linked to an elevated risk of blood clots, heart attacks and strokes in cardiac-surgery patients. Bextra does not have U.S. approval for use during surgery.

In October, the company said studies of heart-bypass patient found an increase in cardiovascular complications among those who got either Bextra or a combination of Bextra and parecoxib compared with people who got opiates. Bextra caused no increase in heart attacks or stroke in arthritis patients, Pfizer said at the time.

FDA: Don't overdo pain pills

By Rita Rubin, USA TODAY

Just because you can buy a pain reliever along with your morning coffee and doughnut at the local convenience store doesn't necessarily mean it's safe to pop the pills for weeks on end.

Time release: Pain relievers shouldn't be taken longer than 10 days, according to the FDA.

By Tim Sloan, AFP

That's the message the Food and Drug Administration is trying to get out to consumers. If you think you need to take naproxen, ibuprofen or aspirin — all nonsteroidal anti-inflammatory drugs, or NSAIDs — for longer than 10 days, do so under a doctor's supervision, the agency is now advising. And don't take any more pills a day than the label, or your doctor, recommends.

If your doctor has prescribed Celebrex or Bextra, two newer NSAIDs known as COX-2 inhibitors, you and your doctor should discuss whether you really need to take the drugs, according to a just-released health advisory from the FDA.

If you're at risk for a heart attack or stroke but not for digestive tract bleeding, you probably should stick with an older NSAID. Theoretically, the COX-2 inhibitors are less likely to cause digestive tract bleeding, but Pfizer, maker of Celebrex and Bextra, has not yet been able to convince the FDA that it should be able to make that claim on the drugs' labels.

In recent weeks, studies comparing Celebrex, Bextra, Vioxx and naproxen — an older NSAID sold over-the-counter as Aleve — with a placebo have shown that they could increase the risk of heart attack and stroke, especially if taken for long periods or by people who are at high risk for such problems. Merck pulled its COX-2 inhibitor, Vioxx, off the market Sept. 30, but Celebrex and Bextra remain.

In light of the new information about risks of heart attack and stroke, Jenkins said, the FDA is requiring that researchers re-evaluate all prevention studies — in which healthy people are given a drug to see whether it prevents a disease or condition — involving Celebrex or Bextra.

Pfizer, maker of Celebrex and Bextra, says a planned FDA advisory committee meeting on COX-2 inhibitors in February "is the appropriate forum for a thorough review of all available data."

Meanwhile, the company said Friday in a statement that "patients should continue to consult their doctor to ensure they get the pain treatment appropriate for their individual medical need."

see full article at USAToday.com

Little Rock Law Firm Sues Pfizer Over Celebrex, Bextra

This drug lawsuit is on behalf of the stockholders:

12/22/04 11:58:41 AM
By Arkansas Business staff, Arkansasbusiness.com Daily Report

Emerson Poynter LLP, a law firm with offices in Little Rock, Houston and Seattle, said Tuesday that it filed a lawsuit against pharmaceutical giant Pfizer Inc., saying the company misrepresented facts about the safety of two drugs, Celebrex and Bextra.

Pfizer removed all marketing for Celebrex on Monday after questions were raised about the pain medication’s safety. Emerson Poynter’s lawsuit is the third Pfizer faces after disclosing Friday that Celebrex and Bextra might increase the chances of heart problems in users.

Last week, Pfizer released a study that Celebrex users had double the chance of experiencing heart problems than patients taking placebo.

Emerson Poynter filed the lawsuit on behalf of shareholders who purchased Pfizer stock between Nov. 1, 2000, and Dec. 16, 2004.

Emerson Poynter, whose Little Rock offices are at 2228 Cottondale Ave., was founded by partners John G. Emerson and Scott E. Poynter, both Arkansas natives. The firm specializes in securities purchaser class action lawsuits

Review Ordered of Studies Using Celebrex, Bextra

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) on Thursday ordered the review of preventative studies involving Pfizer Inc.'s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.

The FDA (news - web sites) also said doctors and consumers should weigh individual benefits and risks when taking painkillers, saying patients vulnerable to gastric bleeding may be appropriate candidates for Cox-2 drugs, that include Celebrex and Bextra