What is the most important information I should know about Bextra?

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Bextra was withdrawn from the U.S. market in 2005.

The manufacturer of Bextra has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (Bextra is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking Bextra.

Do not take Bextra without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to Bextra. Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects. Serious skin reactions have occurred in patients taking Bextra. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking Bextra and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

What is Bextra?

Bextra was withdrawn from the U.S. market in 2005.

Bextra is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Bextra works by reducing substances in the body that cause inflammation, pain, and fever.

Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation.

Bextra may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Bextra?

The manufacturer of Bextra has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (Bextra is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking Bextra.

Do not take Bextra without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to Bextra.

Bextra should not be used for the treatment of pain after coronary artery bypass surgery (CABG). The use of Bextra in such patients has led to an increased incidence of cardiovascular events, deep surgical infections and wound complications. Talk to your doctor before taking Bextra if you are being treated for pain associated with CABG.

Before taking Bextra, tell your doctor if you

• smoke;

• drink alcohol;

• have an ulcer or bleeding in the stomach;

• have liver disease;
• have kidney disease;

• have asthma;

• have congestive heart failure;

• have fluid retention;

• have heart disease;

• have high blood pressure;

• have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or

• are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take Bextra, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Bextra is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Bextra should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take Bextra without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Bextra passes into breast milk. Do not take Bextra without first talking to your doctor if you are breast-feeding a baby. If you are over the age of 65 years, you may be more likely to experience side effects from Bextra. You may require a lower dosage or special monitoring during your therapy.

For Pfizer, a Big Deal and a Test

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By DUFF WILSON

Published: January 26, 2009

After announcing the $68 billion megamerger with Wyeth on Monday morning, Pfizer’s chief executive, Jeffrey B. Kindler, did not have much time to celebrate.

Related

In Wyeth, Pfizer Sees a Drug Pipeline (January 27, 2009)

Wyeth Deal May Slow Pfizer Biotech Acquisitions (January 27, 2009)

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There was too much gloomy news to deal with.

The companies’ combined work force of 128,000 will shed 19,000 jobs. Pfizer will slash its stock dividend in half. And Pfizer is taking a $2.3 billion charge to settle a federal investigation over illegal off-label promotion of its former painkiller, Bextra.

Investors celebrated Mr. Kindler’s big day by sending Pfizer’s stock down more than 10 percent.

And yet, for Mr. Kindler, the Wyeth deal promises a big payoff. The combined company would be the fourth largest in the United States by market value based on Monday’s stock prices, which valued Pfizer at $105 billion and Wyeth at $57 billion. Only Exxon, Wal-Mart and Procter & Gamblewould be larger than Pfizer.

And it gained control of a range of biotech drugs, vaccines, consumer products and research opportunities to try to fill the gaps in its own product pipeline.

“This is not about a single product,” Mr. Kindler, 53, said at the news conference at Pfizer headquarters in Manhattan on Monday morning where the deal was formally announced. “It is about creating a broad, diversified portfolio of businesses, ones in which the people that are great at science can do what they do best and the people that are great at providing access to customers can do what they do best. And it is just such a perfect fit.”

His counterpart, Bernard J. Poussot, 56, the Wyeth chairman, who appeared beside Mr. Kindler, also termed it a “perfect” fit. But it will be Mr. Kindler’s job to make it work. He will be chairman of the merged companies, which will be known as Pfizer, while Mr. Poussot is expected to depart if the merger is completed as planned this year.

If the Pfizer-Wyeth deal had gone into effect last year, Mr. Poussot would have been entitled to about $38 million in cash severance, pension, health benefits and other perquisites. But because of changes the Wyeth board put in place on Jan. 1, the total value of the golden parachute is worth less than half that amount — an estimated $18.3 million.

In many ways, Mr. Kindler, the Harvard-trained lawyer who has led Pfizer since July 2006, had spent the last two years preparing for a big deal. He has already cut $2.8 billion in costs and 15,000 jobs. He has turned research away from the cardiovascular medicines that helped make Pfizer a giant but whose fading glory is embodied in the $13 billion-a-year cholesterol drug, Lipitor, which will lose its United States patent in 2011.

Now, if the deal is completed, Pfizer, which had sales of $48 billion in 2007, is looking forward to absorbing Wyeth, which is based in Morristown, N.J.

As many big mainline pharmaceuticals companies face their own patent problems and the prospect of cheap generic competitors to their best-selling drugs, the Wyeth deal will help Pfizer smooth a potential patent “cliff” into a mere bump in the road, says Barbara Ryan, a Deutsche Bank analyst. A predicted 30 percent drop in revenue in four years will be only 10 percent at worst, she said.

“This just has to happen in this industry,” Ms. Ryan said in an interview. “As a scale player, Pfizer can generate dramatically more earnings out of Wyeth than Wyeth can alone.”

Two Pfizer chairmen before Mr. Kindler have made major acquisitions with grand ambitions, only to see them falter. Pfizer bought Warner-Lambert for $90 billion in 2000 mainly to gain control of Lipitor, and it bought Pharmacia for $60 billion in 2003 to get the painkiller Celebrex. But Lipitor spawned no successor drug, and Celebrex sales plummeted after a similar drug, Vioxx, made by Merck, was linked to strokes and heart attacks.

Mr. Kindler said the Wyeth purchase was different. “We have obviously learned a lot from our prior acquisitions,” he said, conceding they had “hurt morale and hurt productivity.”

To make the Wyeth deal work, Mr. Kindler promised to cut $4 billion in combined spending by 2012 and to slash 15 percent of the companies’ combined work force. But he said he would do so “thoughtfully and being very careful to protect the core asset that makes both of these companies successful.”

Pfizer also said Monday that it would cut its dividend in half, to 16 cents a share, partly to shore up credit ratings, as the company borrows $22.5 billion to help finance the deal from five banks — four of which recently received federal bailout money.

“It’s good to see banks doing what banks are supposed to be doing,” Mr. Kindler said. “I think it is really good for America to support a competitive, strong, healthy, biopharmaceutical industry.”

David Moskowitz, an analyst with Caris & Company, praised the deal for its biotechnology drugs and vaccines from Wyeth and the cost-cutting potential of combined operations. In a note to investors Monday, he predicted an “exciting” year for pharma mergers and acquisitions, with Schering-Plough and Bristol-Myers Squibb being the most likely takeover targets.

Timothy D. Anderson, an analyst for Sanford C. Bernstein, said he expected cost-cutting to be closer to $6 billion. “The next big pharma merger is likely to see a level of cost-cutting not seen before,” he wrote Monday to investors.

Certainly, Wyeth and Pfizer employees were bracing themselves for deep cuts.

Magid Abou-Gharbia, director of the Center for Drug Discovery Research at Temple University, who recently left Wyeth after 26 years as a scientist and manager, said he has been receiving calls from anxious Wyeth scientists.

“I’m trying to be a calming factor,” Mr. Abou-Gharbia said in a telephone interview Monday. “Remind them that I went through three mergers at Wyeth, and after each one, the organization emerged stronger.”

As investors digested Pfizer’s news, the stock fell 10.3 percent to $15.65 a share Monday. Wyeth held steady, down 0.8 percent to $43.39 after rising 12.6 percent Friday on the takeover rumor.

Mr. Kindler defended the dividend cut, saying the Wyeth purchase gave “clarity” to future earnings.

Pfizer also reported its fourth-quarter financial results, showing that revenue dropped 4 percent, to $12.35 billion, as it lost United States exclusivity for the allergy drug Zyrtec and the colon-cancer drug Comptosar.

Excluding special charges, Pfizer said it would have earned 65 cents a share, up from 50 cents a share in the quarter a year earlier. But Pfizer’s earnings dropped by more than 90 percent, to $266 million, or 4 cents a share, after one-time charges — the biggest being the $2.3 billion set aside to settle the Justice Department’s Bextra case.

The government had accused Pfizer of paying off doctors and making false and misleading claims about the drug to encourage its unsafe use for acute and surgical pain. The investigation has also expanded to the marketing and safety of other Pfizer drugs. A spokeswoman for Michael Sullivan, the United States attorney for Massachusetts, who is leading the investigation, did not return phone calls.

Bextra was withdrawn by Pfizer in 2005. The company settled Bextra complaints from 33 states for $60 million last October and agreed to pay $894 million to settle suits over Bextra

On any other day, the Bextra settlement might have been big news for Pfizer — which is why some analysts said the company had probably decided to disclose it on Monday.

Pfizer Stock Shrugs Off $2.3B Bextra Fine; Can Anything Deter Off-Label Promotion?

By Jim Edwards | Sep 8, 2009

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Pfizer’s $2.3 billion settlement with the government over its mismarketing of Bextra “pales” next to the company’s annual revenue, making off-label promotion “easier” in the future, according to an AP story published over the weekend:

PFE 17.08 +0.16 (+0.95% ) Intraday | 3 Month | 6 Month | 1 Year

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Pfizer’s fine is the largest health care fraud settlement in U.S. Justice Department history. But that $2.3 billion total stands small compared to the $44.2 billion in pharmaceutical sales the world’s largest drugmaker rang up last year.

“$2.3 billion looks like a lot of money,” [Dr. Adriane Fugh-Berman, a Georgetown University associate medical professor] said. “But these are highly profitable drugs. It will not take them very long to make up that deficit.”

Well, yes and no. In 2008, I made this same argument: Thatsettlements between the Department of Justice and drug companies amounted to loose change and were therefore ineffective. However, to say that the $2.3 billion Bextra fine is “loose change” is going too far. $2.3 billion is a lot of money, even in Pfizer’s universe. It reduced the company’s Q4 2009 net income by 90 percent, for instance.

But it is true to say that the stock market largely shrugs off significant settlements as if they didn’t happen. Look what happened to Pfizer stock over the period of the settlement provision being made in January and today:

Sure, the stock takes a dip, but that’s more attributable to Pfizer’s acquisition of Wyeth than it is to the fine. And already it’s made up most of its ground.

A similar situation happened when AstraZeneca announced in Julythat it was potentially facing $600 million in unpaid legal bills from its Seroquel litigation. Its Q2 profit was $2.3 billion.

If you can spot the impact of that liability on AZ’s stock, let me know.

Here’s Cephalon’s announcement that it was paying a $425 million fine for its marketing. Its net income in Q3 2008, when the fine occurred, was $112 million (although it does have a settlement reserve built into its income statement).

Sure, there’s sharp dip after the Sept. 29 disclosure, but the ground is made up within a month or so.

To do this properly, you’d need to build a database of dozens of settlements and historic stock prices and run a regression analysis. But I’d be willing to bet that the result would be that settlements are not a significant mover of stock prices compared to overall price movements generally. (Note that I haven’t said a word about the wider movement of the markets, which these companies’ prices seem to follow.)

Clearly, if you read Wall Street analysts’ reports, you often find that they regard settlements as one-off events that shouldn’t affect their overall models too much.

So there’s a self-reinforcing delusion going on here: Companies know that they can increase revenues by promoting drugs off-label. They also know that the fines can be significant. But they’re pretty sure that Wall Street will either ignore the fines, or weight the extra revenues more heavily than than the fines. So the incentives still lie in favor of off-label marketing.

Which, when you look at that $2.3 billion Bextra settlement, is a scary thing to contemplate.