Severe, sometimes life-threatening allergic reaction that can cause extreme swelling (including swelling of the lips and/or throat), hives, vomiting, and other extreme adverse physical reactions and, if untreated, may interfere with heart function. Anaphylaxis can be a reaction to any allergen, but the most common triggers are food, medication, insect stings, and latex. Anaphylaxis typically occurs shortly after contact with or ingestion of the triggering allergen, but it can occur at any time.

Anaphylactic Shock:

Most severe type of anaphylaxis, in which the body’s systemic response to an allergen results in a drastic drop in blood pressure. It may result in loss of consciousness, and if not treated promptly, may lead to death.

Diclofenac:

Sold under the brand names Voltaren© and Cataflam©, Diclofenac is an NSAID used to treat the symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Unlike Celebrex, Diclofenac is not a selective COX-2 Inhibitor.

Familial Adenomatous Polyposis:

A very rare, genetic condition in which the patient develops colon and rectal polyps that often lead to premature development of colorectal cancer. FAP is treated with surgery to remove existing polyps, and patients with FAP must be monitored regularly to check for regrowth of the polyps. Celebrex is currently approved for the treatment of FAP, and has been shown to reduce polyp growth when used in conjunction with standard treatments.

Osteoarthritis:

A disease of the joints, most commonly associated with old age and/or repetitive joint stress, in which the cartilage that normally cushions a joint’s movements breaks down, causing pain and inflammation in the affected joints.

Rheumatoid Arthritis:

A disease in which the immune system attacks the cartilage that cushions a joint’s movements, resulting in pain and inflammation. RA can occur in children as well as adults; it is referred to as Juvenile Rheumatoid Arthritis when it affects patients ages 2-17.

Sulfonamide:

Any of a class of drugs, typically called “sulfa” drugs, that are derived from sulfonic acid. Sulfonamides are most commonly used to treat bacterial infections, hypertension, and gout.

Celebrex comes in 100mg tablets. In clinical studies, patients’ results were measured at dosages ranging from 100mg per day or less (or in some cases, only as needed) to 800mg per day (usually administered in two 400mg doses).

Because of the drastic increase in severe complications, including fatal cardiovascular events, in patients who took the highest possible dosages of Celebrex, it is recommended that it be taken in the lowest possible effective dosage. Several factors may affect an individual patient’s prescribed dosage, including diet, body size, and severity of the condition.

Taking Celebrex as Needed

Some patients are prescribed Celebrex on an “as needed” basis, usually for treating severe pain that is chronic but not constant. Celebrex takes around 3 hours to reach maximum potency, partly dependent on food accompaniment. When taken with high-fat foods, Celebrex may take up to 2 hours longer to reach peak potency. In studies, patients who took Celebrex “as needed” experienced very few adverse reactions and side effects. However, the majority of patients for whom Celebrex is prescribed take it regularly in order to treat degenerative pain conditions (such as arthritis).

Body Size and Dosage:

Dosage is often related to body size and body mass, as these factors affect how potent a drug becomes in a patient’s system. According to Pfizer (manufacturer of Celebrex), in patients under 110 lbs., “the lowest possible dosage” should be used.

Drastic increases in absorption rates have also been discovered in patients over the age of 60 (partly due to lower average body weight) and in patients of African-American descent (for unknown reasons). These factors, along with the nature and severity of the patient’s condition, determine a doctor’s decision on dosage.

In clinical studies, dosages were not determined by individual patient factors, but rather by the condition on which the drug was tested. In some cases, that is how the drug is currently prescribed.

For example, some doctors may prescribe 200mg BID (twice daily) of Celebrex to any patient suffering from Rheumatoid Arthritis, regardless of the patient’s weight, and only adjust the dosage if the patient is under 16 or over 60.

Celebrex Dosages and Lawsuits

Clinical studies showed a much greater incidence of side effects and severe complications in patients who used high doses of Celebrex (400mg per day or more). Part of the decision of the judge in a Celebrex lawsuit is whether there is scientific evidence that a specific dosage can be linked to a litigant’s side effects or complications.

Though a 2007 decision by a San Francisco judge found insufficient evidence for the risks of Celebrex prescribed at 200mg per day, it is unknown whether that finding took into account the body weight, body mass, and other metabolic factors of the patients in question. It is likely that this discrepancy will become the basis of future lawsuits, even if future litigants were taking 200mg of Celebrex per day.

Except in the case of class-action suits, each lawsuit is handled individually, with respect to each patient’s personal experiences. Only a specialized legal representative can determine whether dosage will have a bearing on a specific case. Despite the 2007 decision, there is no reason to believe that Pfizer will not face future lawsuits from patients who took 200mg of Celebrex daily.

The information contained in this web site applies to the drug Celebrex, and to its generic version Celecoxib. According to the FDA, generic drugs are identical to brand-name drugs in use, dosage, effectiveness, format, risk, and active ingredient.

What is Celebrex?

Celebrex (or Celebra, as it is known outside of the US) is the brand name of the drug Celecoxib, a pain treatment medication originally developed by G.D. Searle & Co. and now manufactured by Pfizer. Celebrex is one of a class of pain treatment drugs called NSAIDs.

Chemistry of Celebrex

Chemical Formula: C₁₇H₁₄F₃N₃O₂S

Chemical Name: methylphenyl-trifluoromethyl-pyrazol-benzenesulfonamide

As is evidenced by the ending “-sulfonamide,” Celebrex is a “sulfa drug,” or a member of the drug class sulfonamides. Celebrex may cause an allergic reaction in people with a known allergy to sulfonamides.

What are NSAIDs?

NSAIDs, or Non-Steroidal Anti-Inflammatory Drugs, are used in certain patients to treat chronic pain conditions such as osteoarthritis, rheumatoid arthritis, and in some cases menstrual cramps, as well as acute pain. NSAIDs are designed to have the effectiveness of steroidal pain medications, without the side effects associated with the narcotic steroids.

How Does Celebrex Work?

Celebrex treats inflammation by preventing the body’s synthesis of a chemical called prostaglandin. Prostaglandin has a dual effect in the body: protecting the stomaching and intestinal lining with a layer of mucous (associated with the COX-1 enzyme); and causing inflammation and pain (associated with the COX-2 enzyme). Celebrex is called a Selective COX-2 Inhibitor because it is designed to target the COX-2 enzyme specifically, while sparing the protective effects of the prostaglandin formed by COX-1.

COX-2 Inhibitors have been available since the late 1990s. Learn more about the history of Celebrex.

Celebrex is a COX-2 Inhibitor, a specific subclass of a class of drugs called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), which works to treat pain and inflammation while sparing the enzymes that protect the gastrointestinal lining. Whereas Vioxx (Rofecoxib) and Bextra (Valdecoxib) were withdrawn from the market in 2004 and 2005 respectively, Celebrex and Metacam remain available to consumers suffering from the pain and inflammation of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, severe menstrual pain, or other conditions as determined by specific physicians.

Both Celebrex and Metacam carry prominent FDA-required black box warnings regarding the risk of serious cardiovascular complications. Since the bans of Vioxx and Bextra, many successful lawsuits have been filed by patients who have suffered drastic side effects while taking these drugs. Thousands of Celebrex-related lawsuits have also been filed against Pfizer. Pfizer is settling Celebrex lawsuits individually, in contrast to Merck’s attempt to negotiate a massive settlement to cover Vioxx litigants. Pfizer attorneys report that the drug company expects to pay $500 million in settlements to consumers filing Celebrex lawsuits.

Vioxx (Rofecoxib)

Vioxx was the first release of the then-promising new class of drugs called “super-aspirins.” Merck spent over $80 million on advertising to promote Vioxx, hoping to rival sales of the almost simultaneous release of Celebrex by Pfizer. Vioxx was removed from the market in 2004 after several studies found an increased risk of heart attack and stroke associated with the drug, particularly after long-term use.

Since the removal of Vioxx from the market, thousands of lawsuits have been filed against Merck. The company made a mass settlement in 2007, in an attempt to wipe out the vast majority of the suits at once, but many lawsuits are still pending and more are expected to be filed.

Bextra (Valdecoxib)

Bextra, manufactured by G.D. Searle & Co., became available in 2001 and was prescribed, similarly to other NSAIDs, for the symptoms of osteoarthritis, rheumatoid arthritis, and painful menstruation. It was voluntarily removed from the market in 2005, after the ban of Vioxx caused widespread fear of the major cardiovascular side effects of COX-2 Inhibitors and the risks of Bextra were placed under intense scrutiny. Bextra’s withdrawal from the market was attributed not only to the increased risk of serious cardiovascular events, but to a rare but serious skin reaction associated with the drug.

Mobic (Metacam, Meloxicam)

Meloxicam is currently approved in the US, under the name Metacam, for the treatment of osteoarthritis. Though it is not generally classed into the same category as Celebrex, Bextra, and Vioxx, Metacam has been shown to selectively inhibit COX-2 over COX-1. Metacam has long been used in veterinary applications, primarily for treating osteoarthritis in dogs. It wasn’t until 2004 that it was approved in the US for treatment of osteoarthritis. Its main side effects are similar to other drugs in the class: gastrointestinal complications including ulcers, nausea, vomiting, stomach pain, and in rare cases liver disease and toxicity. It carries the same label warnings as Celebrex, including serious cardiovascular events, allergic reactions, and peptic ulcers or other gastrointestinal complications.

CLASS Study: Celebrex Long-Term Arthritis Safety Study

One of the only long-term studies available on Celebrex, the CLASS study was designed to assess the long-term risks and benefits of NSAID use in patients with arthritis. The study compared the long-term effects of the NSAIDs Celebrex, Diclofenac, and Ibuprofen on 5,800 patients with Osteoarthritis and 2,200 patients with Rheumatoid Arthritis.

Although it was concluded that Celebrex did not carry a higher cardiovascular risk than the other study drugs, it was found that Celebrex combined with a low-dose aspirin regimen caused a four-fold increase in bleeding ulcers and other serious gastrointestinal complications 6 to 9 months into treatment.

Celecoxib Versus Naproxen and Diclofenac in Osteoarthritis Patients: SUCCESS-I Study

The SUCCESS-I study tested the effects of Celebrex compared to the non-selective NSAIDs in treating the pain of osteoarthritis. The study was notable because of its sample size, including over 13,000 participants from 39 countries, but it was not designed to measure cardiovascular risks. The goal of the study was to measure the comparative risk of gastrointestinal complications in patients using selective and non-selective NSAIDs. Patients were given either 200mg or 400mg of Celebrex, 100mg of Diclofenac, or 1000mg of Naproxen daily for 12 weeks.

It was concluded that Celebrex carried a lower risk of gastrointestinal complications, including bleeding ulcers, than non-selective NSAIDs, but did not provide better pain management. The study reported no significant difference in number of serious cardiovascular events during the study (10 in the Celebrex group compared to 1 in the NSAID group), however percentage notwithstanding it would seem that the Celebrex group had a ten-fold higher rate of cardiovascular complications.

APC Trial: Prevention of Sporadic Colorectal Adenomas with Celecoxib

The APC Trial tested the effects of daily Celebrex use in reducing colorectal polyp growth in patients who had undergone surgery to remove adenomas (non-cancerous growths in the colon and rectum). Over 2,000 patients participated in the placebo study beginning in 1999, receiving either 400mg or 800mg of Celebrex daily.

The 2004 withdrawal of Vioxx (Rofecoxib) from the market spurred great public debate over the safety of Celebrex and similar drugs, which resulted in the formation of the Cardiovascular Safety Committee (CSC) to oversee studies involving potentially risky drugs. Additionally, the APC trial was monitored by a Data Safety Monitoring Board (DSMB) which worked together with the CSC to examine the safety of the study. Study results were publicized reporting that Celebrex was associated with an increased risk of cardiovascular complications: specifically, the study found a 2.5% increased risk in patients receiving the lower dosage and a 3.4% increased risk in patients receiving the higher dosage compared to placebo. As a result, the CSC and DSMB made the decision to suspend the use of the drug in the study.

In 2008, the five-year results of the trial became available, measuring the effects of three years of Celebrex therapy after a two-year cessation of the drug. The results showed a 41% decrease in adenomas in patients who received 400mg of Celebrex daily, and a 24% decrease in patients who received 800mg daily during the course of the study. It was still concluded that the drug carried an increased risk of cardiovascular events, particularly in patients with at least two preexisting conditions putting them at greater risk of heart attack or stroke. For these patients, the risk of heart attack and stroke was 3-6% higher than in the placebo group. In patients with no preexisting risk factors, there was still a 1-3% increased incidence of cardiovascular events over placebo.

ADAPT Trial: Alzheimer’s Disease Anti-Inflammatory Prevention Trial

Beginning in 2001, the ADAPT trial, sponsored by the National Institute of Aging, tested the effectiveness of Celebrex and Naproxen (compared to placebo) at delaying the onset of Alzheimer’s Disease in just over 2600 patients with a family history of the disease. The theory was that treating the inflammation in the brain associated with Alzheimer’s might stave off the symptoms of the disease. Study participants received either 400mg of Celebrex daily or 440mg of Naproxen daily. The study was monitored by the Treatment Effects Monitoring Committee (TEMC). Two scales were used to measure the cognitive changes of the patients in the study: the Alzheimer’s Disease Assessment-Cognitive Behavior (ADAS-Cog) and the Clinician’s Interview-Based Impression of Change Plus (CIBIC-Plus).

During the study, the ban of Vioxx and interruption of the concurrent APC trial caused the ADAPT study to receive additional scrutiny. The results at that time showed a slightly higher rate of cardiovascular events in patients taking Naproxen than those taking Celebrex. Because Celebrex was determined unsafe at that time for use in the APC trial and the partial results of the ADAPT trial showed an even higher risk associated with Naproxen, the ADAPT trial, intended to run for 5-7 years, was cut short after 23 months.

A Brief History of Celebrex

1998: Celebrex is approved for the treatment of osteoarthritis and rheumatoid arthritis

When Celebrex was approved by the FDA in 1998, it was a promising new treatment for the millions of people living with the pain of osteoarthritis (approximately 27 million in the US alone) and rheumatoid arthritis (1.7 million in the US). The use of the selective COX-2 inhibitor was intended to prevent the adverse effects that were believed to be linked to the inhibiting of the COX-1 enzyme.

Celebrex was tested against other NSAIDs and against placebos in 2100 patients with rheumatoid arthritis (RA) and 4200 patients with osteoarthritis (OA). It was found to be equally as effective as other NSAIDs at relieving pain and inflammation compared to placebo. With its approval of the drug, the FDA mentioned the possibility that Celebrex carried the risk of cardiovascular complications.

At the same time that Pfizer was preparing to release Celebrex, Merck & Co. was preparing to release their similar drug, Vioxx, which would be marketed to the same population of patients. Celebrex beat Vioxx to the shelves narrowly, enjoying a year of virtually unrivaled sales until the release of Vioxx in 1999. Both Pfizer and Merck & Co. went to great expense to market their respective new drugs to arthritis sufferers, including an emphasis on direct-to-consumer print and television advertising.

How does Celebrex work?

Original Package Warnings for Celebrex

With its initial release, Celebrex came with a package warning about the danger of ulcers and possible interference with platelet function, as has been associated with the entire class of NSAID drugs. Because the original clinical trials were only 6 to 12 months in duration, it was undetermined whether Celebrex posed a risk of serious cardiovascular events with prolonged use.

1999: Packaging Change for Celebrex Warns of Interaction with Warfarin

In 1999, Pfizer changed the package warning on Celebrex to include the danger of interaction with the drug Warfarin, which is an anticoagulant agent. During the original clinical trials, there was no evidence of a particularly adverse reaction with Warfarin, but soon after the release of the drug, the FDA received several reports of patients who had experienced fatal cardiovascular events while taking Warfarin and Celebrex. In several reported cases of patients taking Warfarin, Celebrex reacted with the drug to enhance its anticoagulant effects to unsafe levels. This not only contributed to the possibility of cardiovascular events, but increased the risk of bleeding to death, especially if stomach or intestinal perforations are present.

1999: FDA Approves Celebrex for the Treatment of Familial Adenomatous Polyposis

In 1999, Celebrex was approved by the FDA for the treatment of Familial Adenomatous Polyposis (FAP), a rare but serious hereditary condition in which the patient develops colon polyps that tend to develop prematurely into colon and rectal cancer. During a six-month trial of 83 patients with FAP, there was a 28% reduction in colon polyps in patients who took 400mg of Celebrex daily, compared to a 5% reduction with placebo.

It was emphasized that the use of Celebrex in treating FAP should not be considered a substitute for more traditional treatments, which typically include surgical reduction of tumors and frequent endoscopic surveillance. Coupled with these aggressive techniques for managing FAP, Celebrex was believed to reduce the growth of polyps and thereby aid in the prevention of cancer development in these patients.

2004: Vioxx is Withdrawn from the Market

After studies showed that COX-2 Inhibitor Vioxx (Rofecoxib) caused a dramatic increase in fatal cardiovascular events, including heart attack and stroke, Merck & Co. withdrew the drug in September of 2004. These risks were directly proportional to the length of treatment and dosage that patients received. The Vioxx ban caused a hike in sales for competing drugs Celebrex and Bextra, the only two remaining COX-2 Inhibitors on the market.

In response to the ban of Vioxx, Pfizer agreed publicly that there was also reason for concern surrounding Celebrex, and possibly the entire class of COX-2 Inhibitors, and the risk of death by gastrointestinal perforation, heart attack, or stroke. Pfizer agreed that further studies, as well as meta-research on existing studies, were necessary to determine the absolute safety of the drug. As a concession, Pfizer agreed to suspend direct-to-consumer advertising until further notice from the FDA.

The FDA announced that there was “great concern” over Celebrex and its class of drugs (NSAIDs and COX-2 Inhibitors in particular), but at that time the FDA decided to “keep its options open” regarding the approval of Celebrex. At the same time, doctors and consumers alike were reminded to seek alternative treatments whenever possible.

2005: Bextra is Withdrawn from the Market

In 2005, Bextra (valdecoxib) was withdrawn from the market on recommendation of the FDA after, as in the case of Vioxx, it was discovered that the drug caused an increased risk of serious cardiovascular events, particularly in patients recovering from bypass or other heart surgery. Bextra, manufactured by G.D. Searle & Co. and sold by Pfizer, was also found in rare cases to cause a fatal skin reaction which, despite a related black box warning, was part of the reason for the drug’s withdrawal.

The Bextra ban, though a blow to the pharmaceutical company, was a blessing for the sales of Celebrex, which enjoyed an all-time high after the Bextra ban. At that time, Celebrex became the only COX-2 Inhibitor on the market, and for many chronic pain sufferers, steroidal pain killers are not desirable as an alternative to NSAIDs because of their side effects. Thus, the FDA determined that the benefits of Celebrex outweighed the risks, and the drug was allowed to stay on the market, but with additional safety information enclosed. It was also suggested to the medical community that all patients be advised of the risks and alternatives to NSAIDs, and that they be prescribed in the lowest effective doses. Additionally, it was reiterated that Celebrex is not recommended for patients at otherwise higher risk of cardiovascular complications, patients who are pregnant or breast feeding, or patients with liver problems.

2005: FDA Approves Celebrex for the Treatment of Ankylosing Spondylitis

In 2005, the FDA added Ankylosing Spondylitis to its list of approved uses for Celebrex. Ankylosing Spondylitis, also called spinal arthritis, is a chronic inflammatory disease which can cause rigidity and loss of movement in the neck and spine. During the two pre-approval clinical trials of 6-12 weeks in duration, patients took between 100mg and 400mg of Celebrex daily. The study measured patients’ pain intensity and range of motion, and around half of subjects showed significant improvement compared to placebo. Patients taking the highest dose (400mg daily) showed the most improvement on average. Long-term results of the study are not available.

2006: FDA Approves Celebrex for the Treatment of Juvenile Rheumatoid Arthritis

In 2006, The FDA approved the use of Celebrex for the Treatment of Juvenile Rheumatoid Arthritis (JRA). This disease affects an estimated 300,000 patients aged 2-17 in the US alone. After a six-month clinical study showing only mild to moderate side effects and no other complications, the drug received approval. Celebrex has never been tested on patients under 2 years of age. The study results did not rule out cardiovascular complications with continued and prolonged use, as was seen in the case of Vioxx, but based on the patients’ reports of pain relief the benefits were seen to outweigh the risks.

There is debate about whether longer-term testing should be necessary before a drug can be deemed safe for new usages, especially since drug companies are anxious to release new drugs in order to make sales. It is still unknown whether the treatment of JRA with Celebrex may carry a greater risk of serious complications with prolonged use. Official reports on the long-term effects of Celebrex on JRA sufferers are not yet available, but the drug is still currently being prescribed to JRA sufferers.

After the bans of Vioxx and Bextra in 2004 and 2005 respectively, Celebrex came under scrutiny by the public.

The FDA explained that although the class of drugs known as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) has been linked to an increased risk of major cardiovascular events, Celebrex had not specifically demonstrated a higher level of risk than other NSAIDs (excluding aspirin). In response to the discontinuation of Vioxx and Bextra, the FDA placed a “black box warning” on Celebrex warning of the risks of serious cardiovascular complications. It was also recommended that Celebrex be prescribed in the lowest possible dosages, and that alternative treatments be explored. Additionally, a temporary stay on direct-to-consumer advertising for the drug was established to allow for more research on its long-term safety.

Many consumers felt that these warnings were an indirect statement by the FDA that Celebrex is not a safe drug. After a record campaign of direct-to-consumer advertising touting the safety of Celebrex, many consumers who have experienced complications from the drug have chosen to file lawsuits against Pfizer. As of the end of 2007, there were over 3,000 Celebrex-related lawsuits pending.

Throughout the controversy over Celebrex and COX-2 Inhibitors in general, Pfizer has attempted to preserve its image with the public. In November of 2004, concurrent with the ban of Merck’s “super-aspirin” Vioxx, the San Diego Union Tribune reported that Pfizer halted sales of Celebrex to Turkey after the country argued for stricter label warnings that Pfizer felt would damage the drug’s image of safety.

Pfizer Settling Lawsuits Individually

In contrast to Merck’s mass settlement concerning Vioxx, which ended most of the lawsuits in one fell swoop, Pfizer has elected to respond to each Celebrex- and Bextra-related lawsuit individually. In May of 2008 Pfizer offered a settlement to three firms representing over 200 litigants, with an average offer of about $200,000 per Bextra suit and $40,000-$50,000 per Celebrex suit. Lawyers for Pfizer say the company is willing to spend $500 million overall to settle the lawsuits.

If you are considering filing a Celebrex lawsuit, it is important that you find an attorney with personal injury experience, or better yet, experience in dealing with drug companies.

Time Limits on Celebrex Lawsuits

Most states have strict statutes of limitations on filing drug-related lawsuits. The time limits vary by state, so it is important that you consult a lawyer as soon as possible if you want to file a case.

Many law offices offer free consultations to determine if you have a viable case. The lawyer will need to know the exact dates that you (or your family member or friend) took Celebrex, in what dosages, and for what condition it was originally prescribed. It would be helpful to have documentation of the specific medical complication involved in the claim.

Your lawyer will determine the specific viability of your case, including what size of settlement you may fairly expect to receive, and whether you should file individually or as part of a class-action suit.

2007 Ruling in Favor of Pfizer Stifled Many Lawsuits

An important decision by San Francisco Judge Charles Breyer in 2007 ruled in favor of Pfizer, finding that plaintiffs had not provided sufficient scientific support for their claim that Celebrex had caused serious cardiovascular complications at a dose of 200mg per day. This decision had the potential to affect an estimated 900 pending lawsuits against Pfizer, all concerning patients who were taking 200mg of Celebrex per day. It was unknown whether this would affect the claims of patients who took 200mg of Celebrex twice a day, or whether another litigant may be able to make a different case for the risk of the drug even at lower doses.

Celecoxib Vs. Celebrex: Generic Drugs and Your Rights

Celecoxib is the generic form (and the active ingredient) of the drug Celebrex. Celecoxib is identical to Celebrex in its dosages, routes of administration, strength, safety, quality, purity, and intended uses. The original manufacturer of a drug, in this case Pfizer, is considered responsible for the safety of Celecoxib in all its forms, generic or otherwise.

Your rights are the same, regardless of whether you took generic or brand-name Celebrex. If you or a loved one experienced a severe complication while using generic Celebrex, you are encouraged to consult a personal injury lawyer and to make a report to the FDA.

Over the Counter:

• Aspirin
• Codeine (found in some cough medications and pain killers)
• Diuretics (many diet pills and other “water pills”)
• Ibuprofen

Prescription Only:

Check your prescription information carefully, as this list does not contain brand names.

• Alendronate (for osteoporosis)
• Amiodorone (for irregular heart beat)
• Angiotensin-Converting Enzyme (ACE) Inhibitors (for hypertension)
• Atazanavir (HIV medication)
• Bosentan (for Pulmonary Hypertension)
• Cidofovir (Antiviral)
• Cimetidine (Anti-ulcer)
• Clopidogrel (Anti-platelet)
• Codeine (Pain killer)
• Cyclosporine (Immuno-suppressant / post-organ transplant)
• Delavirdine (HIV drug)
• Dextromethorphan (Cough suppressant)
• Drospirenone (Birth control)
• Efavirenz (HIV drug)
• Entecavir (Antiviral used for Hepatitis B)
• Ethinylestradiol (Birth control)
• Fluconazole (for fungal infections)
• Fluoxetine (for depression)
• Fluvastatin (used to lower cholesterol, and to treat Hepatitis C)
• Fluvoxamine (for depression)
• Furosemide (diuretic)
• Imatinib (Cancer drug)
• Isoniazid (Tuberculosis drug)
• Ketoconazole (anti-fungal drug used in many athlete’s foot and dandruff medications)
• Lithium (for Bipolar Disorder)
• Methotrexate (for Cancer and autoimmune disorders)
• Metoprolol (for hypertension)
• Metronidazole (anti-bacterial)
• Mexiletine (for heart arrhythmia)
• Ondansetron (Antiemetic)
• Paroxetine (for depression)
• Pemetrexed (Cancer drug)
• Prednisone (Steroidal anti-inflammatory / anti-allergy)
• Propafenone (for arrhythmia)
• Rifampicin (antibiotic, antibacterial)
• Ritonavir (HIV medication)
• Sulfamethoxazole (antibiotic)
• Sulfinpyrazone (for gout)
• Tamoxifen (Breast cancer drug)
• Ticlopidine (anti-platelet)
• Timolol (for high blood pressure)
• Tramadol (analgesic)
• Warfarin (anticoagulant)
• Zafirlukast (for asthma)

NSAIDs (traditional NSAIDs include ibuprofen, aspirin, naproxen, meloxicam, and celecoxib), as a class of medications, cause a higher incidence of ulcers, stomach pain, and other gastrointestinal problems. These effects are normally more pronounced in patients taking high doses of NSAIDs for chronic pain. Prescription-strength NSAIDs such as Celebrex have also been associated with serious cardiovascular complications, including stroke and heart attack. These risks caused the discontinuation of Vioxx in 2004 and Bextra in 2005, which increased the uncertainty about the safety of Celebrex.

Though Celebrex remains legal in the US, it is now labeled with a strongly-worded “black box warning” (meaning the warning message is enclosed in a black box to draw patients’ attention), which warns of the danger of cardiovascular complications with Celebrex.

If you have experienced complications while using Celebrex, there is an easy-to-use online service you can use to make a report to the FDA.

Serious Risk Factors Associated with Celebrex:

Patients using Celebrex should be advised of the risk of developing the following:

• Bleeding stomach ulcers
• Liver damage (may be evidenced by nausea, vomiting, fatigue, itching, appetite loss, yellowing of skin or eyes, and dark urine)
• Sudden kidney failure or worsening of existing kidney conditions
• Fluid retention (especially dangerous in patients with high blood pressure or congestive heart failure)
• Severe cardiovascular complications, including heart attack or stroke

Lessen Your Risks By Using as Directed

As with all NSAIDs, it is usually recommended that Celebrex be taken with food or milk, or at least a full glass of water, to minimize the possibility of damage to the stomach or gastrointestinal lining.

You should never take more than one dose of this medication at a time, or take more than directed by a physician. Doing so may increase your risk of serious complications. Even when taken as directed, this medication carries risks. It is very important that you do not take additional medications containing aspirin if you are currently taking prescription NSAIDs, including Celebrex, as this may cause an accidental overdose.

Who Should NOT Take Celebrex

Certain factors may increase your chance of having complications from Celebrex. Celebrex is NOT recommended for patients who:

• are allergic to sulfa drugs or aspirin
• are pregnant or breast-feeding (Celebrex is FDA Pregnancy Category C)
• have recently undergone bypass surgery
• have an increased risk of cardiovascular complications or high blood pressure
• have a history of ulcers, stomach bleeding, or liver or kidney disease
• are currently on an aspirin regimen or taking another NSAID medication
• are heavy smokers or drinkers
• are currently taking any of the drugs in this list:

Reporting Serious Side Effects to the FDA

If you experience or witness a serious side effect or complication of Celebrex, the FDA urges you to report the event through its “MedWatch” service. Your report helps the FDA to gather more complete information regarding the safety of this drug, which could save other patients from suffering the same complications.

Call 911 or your physician immediately if you believe you are having an allergic reaction to Celebrex. It is important that you receive medical attention as quickly as possible in the case of a serious complication.

Allergic Reaction

You should not take Celebrex if you have a known allergy to sulfonamides. In the case of a serious allergic reaction, anaphylactic shock may occur. Symptoms include:

• Trouble breathing
• Swelling of the face and throat
• Hives (Itchy red patches on the skin)

If you have any of these symptoms, stop using Celebrex and seek medical attention immediately.

Overdose

In case of accidental overdose, seek medical attention and contact a poison control center immediately. Symptoms of an overdose may include:

• Nausea
• Stomach pain
• Drowsiness
• Black or bloody stool
• Vomiting blood
• Shortness of breath
• Fainting
• Coma

If you think you or someone you know has overdosed on Celebrex, call 911 or your local poison control center immediately.

Cardiovascular Events (Heart Attack, Stroke)

Celebrex has been associated with the increased risk of severe cardiovascular complications, including heart attack and stroke, especially when taken in large doses and for prolonged periods. Heart attacks and strokes can occur without warning, but here are some symptoms that may indicate an approaching cardiovascular event:

• Chest pain
• Shortness of breath
• Weakness
• Slurred speech

If you have any of these symptoms, call 911 or your emergency physician immediately.

Ulceration and Bleeding

Celebrex has been associated with an increased risk of gastrointestinal complications, including perforations (bleeding ulcers) in the stomach and intestinal lining, which can lead to death. Severe ulceration and fatal internal bleeding may occur without warning, but here are some symptoms of gastrointestinal complications which may require immediate medical attention:

• Epigastric pain (upper abdomen)
• Dyspepsia (severe indigestion)
• Melena (bloody/tarry feces)
• Hematemesis (vomiting blood)
• Vomit that looks like coffee grounds

If you have any of these symptoms, seek medical attention immediately.

Skin Rash/Reaction

In rare cases, Celebrex may cause a severe skin reaction similar to that of a sulfa allergy. Symptoms include:

• Blistering of the skin
• Itching
• Fever

If you develop any of these symptoms while using Celebrex, stop taking the drug and seek medical attention.

Hepatotoxicity (Chemical-driven Liver Damage)

Celebrex may cause a condition called hepatotoxicity, in which ingestion of chemicals, usually medications, causes damage to the liver. The liver plays the role in the body of cleansing chemicals from the bloodstream; it is thereby at increased risk for damage by toxins contained in these chemicals. The symptoms of hepatotoxicity include:

• Nausea
• Fatigue
• Lethargy
• Pruritus (uncontrollable itching)
• Jaundice (yellowing of skin and/or eyes)
• Pain in right upper quadrant
• Flu-like symptoms

If you have any of these symptoms, stop taking Celebrex and seek medical attention.

Reporting Serious Side Effects to the FDA

If you experience or witness a serious side effect or complication of Celebrex, the FDA urges you to report the event through its “MedWatch” service. Your report helps the FDA to gather more complete information regarding the safety of this drug, which could save other patients from suffering the same complications.

Definition of Side Effects

The side effects of a drug include all of its physical effects besides its main intended effect. Typically, drug manufacturers are aware of a drug’s possible side effects, and are required to disclose that information before the drug can be approved by the FDA. Side effects are different from risk factors, in that risk factors are typically more rare and more serious than side effects, and they often don’t come to light until a drug has already hit the market.

Minor Side Effects, Which May Subside During Treatment

The most common side effects of Celebrex are stomach pain or nausea, which may be prevented by taking the medication with food, milk, or a full glass of water. Other minor side effects include:

• Burping
• Hunger
• Weight Changes
• Sweating
• Drowsiness
• Loss of energy
• Muscle pain
• Itching
• Dermatitis
• Sun sensitivity
• Constipation
• Dry mouth
• Yeast infection, systemic or vaginal
• Ringing in the ears
• Dry skin
• Painful menstruation
• Disease of the fingernails and/or toenails

Severe Side Effects of Celebrex:

The following side effects are rare but serious, and require medical diagnosis and attention.

• Allergic reaction (hives, swelling)
• Breast tumors
• Diabetes
• High cholesterol
• Water retention
• Drop in potassium levels
• Rupture in stomach or intestinal wall
• Anemia
• Increased platelet count
• Migraines
• Hearing loss
• Hemorrhoids
• Blood hemorrhaging under the skin
• Bronchitis
• Abscess
• Fever
• Numbness or tingling
• Bladder control problems
• Joint inflammation
• Abnormal liver function
• Herpes Simplex infection
• Vaginal infection or inflammation