“Today’s actions protect and advance the health of the millions of Americans who rely on these drugs everyday,” said Dr. Steven K. Galson, Acting Director of FDA’s Center for Drug Evaluation and Research (CDER). “FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks.”

FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA 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 (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency’s Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.

To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.

Additional information about today’s announcements is available on FDA’s Web site at www.fda.gov/cder. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).

The boxed warning for all non-steroidal anti-inflammatory drugs (NSAIDs), including Celebrex, will also contain information regarding gastrointestinal risk that is already included elsewhere in their current labels.

In addition, the FDA is asking manufacturers of all over-the-counter NSAIDs to revise their labeling to include more information on the cardiovascular and gastrointestinal risks as well as a warning about potential skin reactions.

Pfizer and the FDA plan further discussions regarding the precise content of the Celebrex label. Pfizer has accumulated extensive Celebrex clinical data over the past 10 years involving more than 40,000 patients. Pfizer also reaffirmed its commitment to conduct additional long-term clinical studies evaluating the benefits and risks of Celebrex.

Pfizer also said it will work closely with the FDA to develop a guide to assist patients and their healthcare professionals in making the best decisions for treating their arthritis pain.

Regarding Bextra, Pfizer’s other oral Cox-2 inhibitor, the FDA informed Pfizer late yesterday that, in the agency’s view, Bextra’s cardiovascular risk could not be differentiated from other NSAIDs. However, the agency has concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warrants its withdrawal from the market.

Pfizer respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA. Pfizer said it will explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients. For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options.

In addition, at the request of European regulators, Pfizer will also suspend sales of Bextra in the European Union. The company is in contact with other regulatory agencies around the world and will take appropriate measures based on those discussions.

Pfizer was informed by the FDA of its conclusions regarding Celebrex and Bextra on Wednesday afternoon, one day after the company held a meeting with financial analysts. Pfizer received the request from the European regulators early Thursday morning. Pfizer said it is evaluating the operational and financial impact of these actions.

What should I do if I am currently taking Bextra?

You should speak with your doctor immediately to investigate options to discontinue Bextra and seek alternative treatments.

Stevens-Johnson Syndrome

In addition to cardiovascular problems, Bextra has been linked to a rare but sometimes fatal skin condition known as Stevens-Johnson Syndrome (SJS). SJS is a severe inflammatory eruption of the skin and mucous membranes, either following a respiratory infection, or, as in the case of Bextra-linked SJS cases, as an allergic reaction to a drug. For more information on SJS, see The Stevens Johnson Syndrome Foundation. According to Pfizer, SJS is the primary reason the FDA requested they pull Bextra.

Celebrex

With the withdrawal of Bextra and Vioxx, Celebrex is the only two selective COX-2 agent currently on the U.S. market. Important Celebrex information:

• FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex
• Public Health Advisory Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)

Non-Selective NSAIDS

From the FDA: “Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an OTC NSAID is needed for longer than ten days, a physician should be consulted.” Among the OTC NSAIDS: Ibuprofen (Motrin, Advil), Ketoprofen (Actron), and Naproxen (Aleve). See a more complete list of non-selective NSAIDS.

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The Food and Drug Administration (FDA) today requested Pfizer recall arthritis drug Bextra (valdexocib) and change the warning label on Celebrex (celecoxib). The withdrawal is the result of several studies calling into question the risks of this class of drug, including heart damage from long-term use, gastroinestinal bleeding, and a life-threatening skin condition.

Both drugs are non-steroidal anti-inflammatory drugs; the FDA is asking makers of all drugs in this class to revise their warning labels to include the same boxed warning as Celebrex. The withdrawal and warnings comes on the heels of the Vioxx recall in September, 2004.

Articles

Pfizer pulls Bextra off the market: FDA cites health concerns in asking drugmaker to withdraw arthritis painkiller. CNNMoney.com. April 7, 2005: 10:36 AM EDT

“The FDA cited inadequate information on possible heart risks from long-term use of the drug as well as “life-threatening” skin reactions, including deaths.”

Doctors Back Bextra Ban. Forbes. April 7, 2005: 1:35 PM ET

“Analysts and doctors agreed that since Bextra is being pulled Merck’s (nyse: MRK - news - people ) similar Vioxx, which was withdrawn in September, is unlikely to ever return to the market.”

Pfizer Halts Bextra Sales in U.S., Europe. Reuters. April 7, 2005 01:52 PM ET .

“Pfizer Inc. on Thursday agreed to suspend sales of its arthritis drug Bextra after U.S. and European regulators said the risk of serious side effects, including a potentially fatal skin allergy, outweigh the benefits.

“The U.S. Food and Drug Administration also asked Pfizer to add a black box warning — the strongest possible — to the label for its painkiller Celebrex.”

Non-selective NSAIDs

* There are many OTC Combinations with ibuprofen: Advil Cold And Sinus, Advil Cold, Advil Allergy Sinus, Children’s Advil Allergy Sinus, Ibuprohm Cold and Sinus, Sine-Aid IB, Children’s Motrin Cold.

** There are over-the-counter versions of these prescription medications.

The Food and Drug Administration (FDA) learned last night from the National Cancer Institute (NCI) and Pfizer, Inc., that NCI has stopped drug administration in an ongoing clinical trial investigating a new use of Celebrex (celecoxib) to prevent colon polyps because of an increased risk of cardiovascular (CV) events in patients taking Celebrex versus those taking a placebo.

Patients in the clinical trial taking 400 mg. of Celebrex twice daily had a 3.4 times greater risk of CV events compared to placebo. For patients in the trial taking 200 mg. of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

A similar ongoing study comparing Celebrex 400 mg. once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk.

Although these are important findings, at this point FDA has seen only the preliminary results of the studies. FDA will obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action.

While we have not seen all available data on Celebrex, these findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx was recently voluntarily withdrawn by Merck. 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.

Physicians should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients. FDA advises evaluating alternative therapy. At this time, if physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex.

Patients who are currently taking Celebrex and have questions or concerns about the drug should discuss them with their physicians.

Celebrex was approved in 1998 for the treatment of osteoarthritis and rheumatoid arthritis. Previous large studies of Celebrex, including clinical trials and epidemiology studies, have not suggested the sort of CV risk found in the NCI polyp study. Because similar long-term studies of other products in the class of non-steroidal anti-inflammatory drugs (NSAIDS), other than Cox-2 inhibitors have not been done, it is not known whether other NSAIDS pose a similar risk.

FDA will provide updates on Celebrex in particular and this class of drugs in general as more information becomes available.