Bextra Pharmaceutical Lawsuits

Study Links Certain Painkillers to High Cholesterol Levels

2007-02-15T14:46:00.000-08:00

Date Published: Tuesday, February 13th, 2007

A new study published last month in the journal Arthritis Research & Therapy sheds new light on why the class of painkillers known as COX-2 inhibitors may lead to an increased incidence of heart attacks. Researchers at Winthrop-University Hospital in Long Island have determined that controversial drugs such as Vioxx and Bextra may impede the body’s ability to purge excess cholesterol.

“To our knowledge, this is the first study that describes the effects of COX inhibition on reverse cholesterol transport proteins,” the authors wrote. “Our results suggest that the cardiovascular hazard observed with COX inhibitors may result not only from enhanced platelet aggregation [blood clots], but also from interference with cholesterol outflow.”

Drugs such as Vioxx and Bextra were commonly prescribed in the treatment of arthritis pain before they were each removed from the market by the FDA due to safety concerns. The new research suggests that these medications block the patient’s ability to process lipid loads, allowing cholesterol to build up. To this point, researchers have focused on the risk of blood clotting as the leading cause of cardiovascular problems in these patients. “Increased cardiovascular risk with COX inhibition may be ascribed at least in part to altered cholesterol metabolism,” they claim.

“Selective COX-2 inhibitors reduce pain, stiffness, and inflammation with efficacy equivalent to non-selective NSAIDs, but with reduced gastrotoxicity,” the researchers note. “Unfortunately, adverse effects on coronary heart disease risk with prolonged use of COX-2s may offset any gastrointestinal benefit.”

Centre bans arthritis drug Bextra, finally

2005-09-02T18:23:00.000-07:00

Centre bans arthritis drug Bextra, finally

TIMES NEWS NETWORK[ FRIDAY, AUGUST 05, 2005 01:54:50 AM]

MUMBAI/NEW DELHI: The Indian government has issued a notification banning Bextra (Valdecoxib) one of Pfizer’s best selling drugs, months after the US Food & Drug Administration (USFDA) ordered its withdrawal.

The notification, which was issued last week, came after months of deliberation by the authorities. An expert committee under the health ministry recommended in May that the arthritis pill Valdecoxib be banned in India. The ban will affect over 50 brands, which account for a sizeable chunk of the over-Rs 200 crore cox-2 inhibitor market.

In April this year, the USFDA asked Pfizer to withdraw Bextra (Valdecoxib) due to concerns of serious, unpredictable and potentially life-threatening skin reactions, including death in patients using Valdecoxib.

According to reports, there were over 155 reports of adverse reactions to Bextra, which was commonly used to relieve pain and inflammation from arthritis, worldwide. Bextra had sales of $1.4bn last year.

Following the USFDA’s orders to Pfizer, the Drugs Controller General of India (DCGI), started its own process of reviewing the drug. The domestic industry, which had withdrawn their versions of Rofecoxib (a drug similar to Valdecoxib) when the innovator Merck recalled the product globally, were reluctant to do the same with Valdecoxib.

The reason could be that Valdecoxib was a newer drug, and it was doing much better than Rofecoxib.

The total Valdecoxib market was valued at close to Rs 100 crore with the top 10 brands accounting for almost 70% of the market. Glenmark’s Valus is the leading brand, followed by Nicholas Piramal’s.

Merck's Chief Steps Down; Company Insider Replaces Him

2005-05-31T18:44:00.000-07:00

Merck's Chief Steps Down; Company Insider Replaces Him
By ALEX BERENSON

Raymond V. Gilmartin resigned as chairman and chief executive of Merck today, ending a troubled decade-long term during which Merck lost its place as the world's pre-eminent drug maker and was forced into a drug recall that has clouded its future..

Merck, the third-largest American drug maker, named an insider, Richard T. Clark, its 59-year-old head of manufacturing, as the new chief executive. Merck said the chairman's position would remain vacant for at least a year.

After a six-month search, Merck's inability to find someone to assume both of Mr. Gilmartin's titles highlights the deep problems that the company faces in his wake, including a dearth of new drugs and thousands of lawsuits over Vioxx, the painkiller that Merck stopped selling last year after studies linked it to heart attacks.

Mr. Gilmartin had originally planned to retire next March, when he will turn 65.

Despite Merck's proud history and reputation for scientific excellence, several executives outside the company reportedly turned down the chance to run it, including Kevin W. Sharer, the chief executive of Amgen.

Lawrence A. Bossidy, a longtime Merck director who headed the search committee, declined to say today whether Mr. Clark was the company's first choice.

In place of a corporate chairman, Mr. Bossidy will act as chairman of the board meetings and head a three-person executive committee that will advise Mr. Clark. Mr. Bossidy, the former chairman of Honeywell, is a forceful executive, and some analysts said they believed he had effectively taken control of Merck. But Mr. Bossidy and Mr. Clark both said today that Mr. Clark would run the company.

"There's no question that I am in charge," Mr. Clark said in a conference call with reporters.

In a later interview, Mr. Clark said he expected to serve as chief executive for at least five years and that - true to Mr. Gilmartin's long-stated policy - would not merge Merck with another big drug maker. Mr. Clark said he planned to conduct a strategic review of Merck's business but could not promise any specific changes.

As Merck's new chief, Mr. Clark will lead a company suffering from poor morale, a lack of promising new drugs, and a potential liability of $15 billion or more over Vioxx, which, Merck promoted heavily despite years of concern from outside scientists and its own researchers about the drug's risk. .

With just over five years before he reaches Merck's mandatory retirement age of 65, Mr. Clark has limited options for major changes, analysts said. Because bringing new medicines to market is a slow process, drug companies need years to reverse their fortunes. And Merck lags behind other big drug makers in licensing new medicines from biotechnology companies, which recently have found more new treatments than conventional drug companies.

Mr. Gilmartin will leave Merck and its board immediately but remain as a special adviser to the executive committee, the company said. Mr. Gilmartin said today on the conference call that his decision to leave now was not demanded by the board.

"This is my choice," he said.

Mr. Clark said that he had immediately accepted when Mr. Bossidy offered him the job on Wednesday at Merck's headquarters in Whitehouse Station, N.J.

"Being with this company 32 years, and this company being a major part of my life, it was a great honor," he said.

Mr. Clark will be paid $1.1 million annually and receive 45,000 shares and 125,000 stock options this year and 90,000 shares and 250,000 stock options next year.

Merck's shares have fallen 60 percent from their peak in 2000 and 25 percent since the company recalled Vioxx last September. Today, Merck's shares slipped 18 cents to close at $34.75 on the New York Stock Exchange.

Still, Merck remains immensely profitable, with 62,000 employees, $22 billion in annual sales and $6 billion in profits.

Mr. Clark's promotion received mixed reviews. Some drug industry analysts criticized the succession plan, saying that Merck needed a single leader to solve its problems. In addition, Mr. Clark, who has worked at Merck since 1970, has no experience in drug marketing or research, generally considered the two areas most crucial to drug makers.

"Clark spent a lot of time talking about how he is a change agent," Les Funtleyder, an industry analyst at Miller Tabak, a small investment bank, wrote in a research note. "He refused to say how they would change. Given how much time they had to think about this, it is surprising how little they were willing to share."

Other analysts, though, said Mr. Clark was a strong executive who might help unify Merck and was also expert at controlling costs.

"Mr. Clark may possess the personal attributes and the relevant experience of a leader who is likely to relentlessly focus on improving the bottom line," Tony Butler, an analyst at Lehman Brothers, wrote in a research note.

Still, Mr. Clark did not seem fully in control during his first day as chief executive. In the conference call with reporters, Mr. Bossidy answered most questions.

But in an interview afterwards, Mr. Bossidy said he and the other members of the three-person executive committee would be only advisers. Mr. Clark will run Merck, Mr. Bossidy said.

"He's going to be the one who's held accountable," he said. "In terms of operating decisions, he has full authority to act in terms of the company."

Mr. Bossidy said that Mr. Clark would be the leading candidate to become Merck's chairman within a year to 18 months. In the interim, Mr. Clark will have the executive committee to help him work through Merck's problems, Mr. Bossidy said.

"It's unfortunate that because he didn't answer all the questions in detail today that people conclude that he's just not going to do anything," Mr. Bossidy said. "It's just not right."

For Mr. Gilmartin, today's announcement ends years of failure. Mr. Gilmartin is widely liked personally, but his tenure at Merck has been little short of disastrous. When he became chairman and chief executive of Merck in 1994, the company was considered the most innovative big drug company in the world, renowned for the quality of its research.

But Mr. Gilmartin, who joined Merck from Becton-Dickinson, a much smaller medical-products company, never gained full control of the drug maker. Merck's research labs were run by Dr. Edward M. Scolnick, a brilliant and irascible scientist whom many people inside Merck viewed as the company's real chief, before his retirement in 2002.

After finding new treatments for H.I.V., osteoporosis, cholesterol and asthma during the 1980's and 1990's, Merck's labs have hit a dry spell for the last several years, with several drugs failing in late-stage development.

In addition, Merck repeatedly failed to meet its financial projections to Wall Street and lost a crucial patent lawsuit over Fosamax, its osteoporosis treatment. The biggest blow to the company came in September, when Mr. Gilmartin announced that Merck would stop selling Vioxx.

* Copyright 2005 The New York Times Company

Pfizer talking with FDA about Celebrex Bextra's return to market is still unclear, CEO says

2005-05-25T14:33:00.000-07:00

Pfizer talking with FDA about Celebrex Bextra's return to market is still unclear, CEO says
By Elana Schor, Medill News Service
Last Update: 5:33 PM ET May 17, 2005

WASHINGTON (MarketWatch) -- Pfizer is waiting to finish negotiations with the Food and Drug Administration over the labeling of its anti-inflammatory drug Celebrex before pushing for the FDA to return Bextra to the market, CEO Hank McKinnell said Tuesday.

The FDA asked Pfizer (PFE: news, chart, profile) in April to pull Bextra after studies revealed potential for a serious skin reaction in some patients taking the painkiller. Bextra also was linked to cardiovascular side effects similar to those caused by two fellow COX-2 inhibitors: Vioxx, recalled by Merck in 2004, and Celebrex, which was required by the FDA to have a strong black box warning on its label....

Bextra

2005-04-26T12:49:00.000-07:00

I am looking for your opinon on Bextra. What do you think?
Should Bextra have been pulled when the oter Bextra similar drugs were pulled?
Have you taken Bextra?
Do you know anyone who has taken Bextra?
Please feel free to use the comments part to write whatever you want...
I'd love to hear your Bextra opinions.

Bextra Charges Hit Pfizer Profit

2005-04-26T12:41:00.000-07:00

NEW YORK (Reuters) - Pfizer Inc. (PFE), the world's largest drugmaker, on Tuesday said first-quarter earnings tumbled on charges for the suspension of sales of its arthritis drug Bextra and the repatriation of overseas profit.

Pfizer said it earned $301 million, or 4 cents per share, compared with $2.33 billion, or 30 cents per share, a year earlier.

Excluding special items, earnings would have been 54 cents per share. Analysts polled by Reuters Estimates, on average, expected 53 cents per share, which was the company's own forecast.

Pfizer forecast 2005 earnings would fall almost 7 percent to $1.98 per share, excluding one-time items, down 2 cents from the forecast it gave two weeks ago. It reaffirmed its growth forecast for 2006 and 2007.

``Pfizer is still saying that 2005 will be a transition year and that strong growth will resume in 2006 and 2007, so their slightly lower earnings guidance for this year is immaterial,'' said Cathay Financial analyst Sena Lund.

Pfizer, which is based in New York, took a charge of $2.19 billion in the quarter for the planned repatriation this year of $28.3 billion in profits earned overseas and $766 million in charges for Bextra.

Earlier this month, Pfizer agreed to suspend sales of Bextra after U.S. and European regulators said the risk of serious side effects from the drug, including a potentially fatal skin allergy, outweighed the benefits.

The company had been counting on Bextra, which had sales in 2004 of $1.3 billion, to bolster profits at a time when Pfizer's earnings growth has careened to a halt due to generic competition for other medicines.

The U.S. Food and Drug Administration also asked Pfizer to add a black box warning -- the strongest possible -- to the label for its older arthritis drug, Celebrex.

Celebrex is in the same Cox-2 family of drugs as Bextra and Vioxx, the Merck & Co. (MRK) medicine that was pulled off the market last year after being shown to double the risk of heart attack and stroke.

Global sales of Celebrex, one of Pfizer's other long-time engines of profit growth, fell 47 percent in the first quarter to $411 million.

Quarterly sales of Pfizer's cholesterol fighter Lipitor, the world's top-selling drug, jumped 23 percent to $3.08 billion. Patients have flocked to the potent medicine following new studies showing the lower cholesterol is driven the less risk patients have of heart attack and stroke.

Lund, who holds shares in Pfizer, said Lipitor's annual sales will likely increase to ``well over $15 billion'' if future U.S. guidelines suggest even lower levels of ``bad'' LDL cholesterol.

Pfizer said quarterly sales of impotence treatment Viagra grew only 5 percent to $438 million, amid competition from Eli Lilly and Co.'s (LLY) longer-acting Cialis. Sales of epilepsy treatment Neurontin, now facing competition from cheaper generics, fell 74 percent to $182 million. Anti-depressant Zoloft rose 4 percent to $845 million, growth checked by concerns that its class of medicines may increase the risk of suicidal behavior.

Although earnings will fall this year due to patent expirations and declining sales of its arthritis drugs, Pfizer repeated previous forecasts of double-digit profit growth in 2006 and 2007, thanks largely to aggressive cost-cutting.

Aetna stops paying Bextra drug claims

2005-04-15T11:25:00.000-07:00

NEW YORK, April 11 (Reuters) - Health insurer Aetna Inc. (AET) said on Monday it is not paying any claims for Bextra, a pain reliever that the FDA requested to be removed from the market, for prescriptions as of April 7.

The Hartford-based company said it is contacting more than 33,000 customers who have used Bextra to inform them of the U.S. Food and Drug Administration's (FDA) decision to ask that Bextra be withdrawn from the market.

Pfizer Inc. (PFE) agreed to suspend sales of Bextra after U.S. and European regulators said the side effects, including a potentially fatal skin allergy, outweigh the benefits.

Aetna Pharmacy Management has instituted computer system edits that will automatically block Bextra prescriptions from being paid.

Besides the direct communications, Aetna Pharmacy Management will communicate the news concerning Bextra and increased warnings the FDA is requiring of all Cox-2 inhibitors and non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen, on its corporate and pharmacy Web sites in an attempt to reach all members.

The FDA has been studying the safety of Cox-2 inhibitors since Merck & Co. Inc. (MRK) voluntarily recalled Vioxx in September 2004 after a clinical study showed an increased risk of cardiovascular problems.

Bextra and other drugs pulled

2005-04-13T12:59:00.000-07:00

At the end of September 2004, Merck announced a voluntary worldwide withdrawal of its COX-2 inhibitor VIOXX® (rofecoxib), an arthritis and acute pain medication. The company took the decision when the drug was linked to more than 100,000 heart attacks and strokes in the United States. Attention quickly shifted to Pfizer, who had two similar drugs valdecoxib (BEXTRA®) and celecoxib (CELEBREX®) on the market. Many had expected that these drugs would also be withdrawn. However, in a surprising stance Pfizer stood by its COX-2 inhibitor drugs and even announced that it was looking into whether it’s best-known and biggest selling COX-2 inhibitor CELEBREX® might actually help prevent heart attacks. Pfizer may now be regretting that decision as the FDA has requested that valdecoxib (BEXTRA®) is withdrawn from the market stating that the overall risk versus benefit profile for the drug is unfavorable.

Double whammy

In Pfizer's case, the withdrawal of BEXTRA® came along with the news the FDA will also require the company to add a black-box warning to the popular and bigger-selling drug CELEBREX®. The labeling must now include a black-box warning, highlighting the potential for increased risk of cardiovascular events and the potential life-threatening gastrointestinal bleeding associated with the use of COX-2 inhibitors.

Celebrate Celebrex

Many observers were surprised that the FDA did not insist that CELEBREX® was also withdrawn from the market. The agency commented that it had singled out BEXTRA® for suspension as it affords no added advantage as a painkiller and in addition can also cause a potentially life-threatening skin condition called Stevens-Johnson syndrome, an allergic reaction that usually begins as a blistering of the mouth and lips and can spread to the rest of the body. Pfizer do have some cause for celebration in that CELEBREX® is now the only selective COX-2 inhibitor on the market. In 2004, 23.9 million prescriptions were written for CELEBREX®, and Pfizer hope that this will increase in 2005. The news isn’t so good for Merck who had hoped to get VIOXX® back on the market. If the FDA had asked Pfizer to temporarily suspend BEXTRA® that might have indicated a positive thing for VIOXX® but the all-out withdrawal indicates a bleak future for VIOXX®. The black-box warning required by the FDA will make it increasingly difficult for Pfizer to continue with the direct-to-consumer advertising of CELEBREX® which has already come under criticism for not being careful enough about presenting potential side effects.

Patients feel the pain

Many arthritis sufferers who had been taking VIOXX® switched to the other COX-2 inhibitors that were on the market. For those patients that made the change to BEXTRA® they are now facing the challenge of finding another drug to treat their arthritis associated pain. Some may switch to Pfizer’s other COX-2 inhibitor CELEBREX® and others may switch to the older non-selective non-steroidal anti-inflammatory drugs (NSAID) such as ibruprofen or naproxen which have the added advantage of being available over-the-counter. However, the FDA is also requiring that that all manufacturers of NSAIDs revise their labeling to provide more specific information about the potential cardiovascular and gastrointestinal risks of their individual products. This may cause some concern to patients and some may feel they want to abandon this class of drugs altogether in favor of something else such as acetaminophen or aspirin - the only pain relievers available without the new FDA required warnings.

Pass the aspirin

According to some estimates, a trillion aspirin tablets have been taken in its long history. Aspirin is effective, relatively safe and is extremely cheap. So what's not to like about aspirin? Well, for some compliance may be a real issue as patients have become used to their one-a-day options. To get the same anti-inflammatory effect as one 200-milligram CELEBREX®, it may be necessary to take 12 or 14 aspirin. For simple pain relief, the dose would be approximately four to six tablets a day. Also there is a psychological aspect to pain relief; many patients just don't think aspirin works as well as newer more expensive, anti-inflammatory drugs. With the low cost of aspirin, it’s also unlikely that the pharmaceutical industry will spend money on marketing the benefits of aspirin.

Widely recognized as easier on the stomach than aspirin, acetaminophen is another alternative that is safe to use and readily available, but overdose is a problem as the drug is highly toxic to the liver.

Off to court

When a pharmaceutical company takes the dramatic step of taking a $1 billion medicine off the market, one can be sure that lawyers will be quick to offer their services to patients and investors eager to sue. However, it may seem bizarre but Pfizer, a drug company who were forced to withdraw their drug may not experience the same flood of lawsuits as Merck, a company who voluntarily withdrew their drug. The difference is that in the case of BEXTRA®, the FDA cited an increased risk of rare but serious skin reactions as having tipped the balance against Pfizer's painkiller. Regulators concluded the risk of heart attack and stroke was comparable to other medicines. Luckily for Pfizer, they have included a warning about skin reactions on BEXTRA® labels for over a year. This is expected to help limit potential legal liability since the skin problems occur far less frequently than the cardio-vascular events. But they will certainly not escape the courthouse. A series of securities lawsuits have been filed accusing Pfizer executives of damaging investors by making false and misleading statements about the safety of CELEBREX® and BEXTRA®. Several consumer lawsuits and product liability cases have also been filed alleging that the company misled patients who bought BEXTRA® and caused serious health injuries to those who took the drug.

Kudos to the FDA

The FDA must be given credit for their tough stance on protecting the public health. Observers feel that the decision to withdraw BEXTRA® may represent a shift in the agency’s management of a drug’s risk-benefit equation with focus changing from emphasizing the benefit of a product to managing any associated risk. However, whether the agency will have the courage to continue with this tough approach when another unsafe drug inevitably comes along and when the publics’ attention is diverted elsewhere is uncertain. Let’s hope so – even if the drug is CELEBREX®.

Painkiller Bextra pulled from shelves

2005-04-13T12:57:00.000-07:00

Months after Pfizer temporarily pulled the arthritis drug Celebrex from its shelves because of an increased risk of heart attacks, the company has yanked another drug from distribution. On Thursday, the painkiller Bextra was taken off the market in the United States and the European Union. The Food and Drug Administration noted that users of a number of Bextra users had serious, sometimes fatal, skin reactions to the drug.

Bextra belongs in the class of nonsteroidal anti-inflammatory drugs, or NSAIDs. Bextra is part of a class of NSAIDs known as a Cox-2 inhibitor. Cox-2 inhibitors were also used in another painkiller that received unwanted attention, Merck’s Vioxx. The Vioxx scare sparked interest in increasing awareness and safety of such medication.

Celebrex is still on the market. However, the FDA wants all prescription NSAIDs to carry warning labels about the increased risk of cardiovascular side effects. Bextra was singled out by the FDA because of the side effect to skin. Researchers are still unsure whether there is enough information to determine if one prescription painkiller is safer than the other. The FDA is also asking manufacturers of non-prescription NSAIDs to carry revised and strengthened warning labels.

The government is now telling people to consult their doctors and take the lowest possible dose. Pfizer recommends people to stop taking Bextra but disputes the FDA ruling that Bextra is too risky to sell. In February, the FDA was less confident about Bextra than Celebrex and Vioxx. Bextra, also known by the name valdecoxib, had been approved by the FDA in 2001.

FDA bans sale of Bextra joint ache painkiller

2005-04-12T19:54:00.000-07:00

The Food and Drug Administration has followed the US FDA's lead by banning the sale of Bextra, a kind of painkiller for joint aches which puts users at risk of heart attack and skin conditions.

The US FDA on April 7 asked Pfizer to withdraw Bextra from the market and announced actions to be taken regarding the marketing of NSAIDs (non-steroidal anti-inflammatory drugs).

Bextra has been recalled.

2005-04-08T20:50:00.000-07:00

The Food and Drug Administration (FDA) has asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market. FDA is also asking manufacturers of all marketed prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use.