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FDA Hearings on Celebrex, Vioxx Labels Could Be Crucial in Arthritis-Drug Fight
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Vioxx
Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation: Serious GI toxicity, such as bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Minor GI problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and the steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only 1 in 5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has been demonstrated that upper GI ulcers, gross bleeding, or perforation caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for 1 year. These trends continue thus, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
It is unclear, at the present time, how the above rates apply to VIOXX. Among 3,357 patients who received VIOXX in controlled clinical trials of 6 weeks to 1 year in duration (most were enrolled in 6-month or longer studies) at a daily dose of 12.5 mg to 50 mg, a total of 4 patients experienced a serious upper GI event, using protocol-derived criteria. Two patients experienced an upper GI bleed within 3 months (at Days 62 and 87, respectively) (0.06%). One additional patient experienced an obstruction within 6 months (Day 130) and the remaining patient developed an upper GI bleed within 12 months (Day 322) (0.12%). Approximately 23% of these 3,357 patients were in studies that required them to be ulcer free at study entry. It is unclear if this study population is representative of the general population. Prospective, long-term studies required to compare the incidence of serious clinically significant upper GI adverse events in patients taking VIOXX vs comparator NSAID products have not been performed.
NSAIDS should be prescribed with extreme caution in patients with a prior history of ulcer disease or GI bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for and adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high-risk patients, alternate therapies that do not involve NSAID products should be considered.
| Vioxx® | |
| Brand Name: | Vioxx® |
| Active Ingredient: | rofecoxib |
| Strength(s): | 12.5mg & 25mg tablets or 12.5mg/5ml & 25mg/5ml suspension |
| Dosage Form(s): | Tablets and oral suspension |
| Company Name: | Merck & Co., Inc. |
| Availability: | Prescription only |
| *Date Approved by the FDA: | May 21, 1999 |
| *Approval by FDA does not mean that the drug is available to consumers at this time. | |
| What is Vioxx used for?
Vioxx is used to relieve:
Who should not take Vioxx? You should not take Vioxx if you have experienced asthma, hives, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). A few examples of other NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen. Special Warnings with Vioxx: Serious problems from stomach ulcers, such as bleeding, are well-known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Vioxx. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Vioxx and call your health care provider right away. Check with your health care provider. Vioxx may not be right for you, if you:
General Precautions with Vioxx: Do not stop taking any medications that you have been prescribed without first talking to your doctor. Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away. Vioxx can cause your body to retain fluid and swell. Your health care provider will decide if Vioxx is right for you, if you:
If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Vioxx should not be given to aspirin-sensitive patients. The safety and effectiveness of Vioxx in patients below the age of 18 years has not been determined. What should I tell my doctor or health care provider? Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. Because certain other medications can interact with Vioxx, review all medications that you are taking with your health care provider, including those that you take without a prescription. Your health care provider may have to adjust your dose or monitor you more closely if you take:
Avoid taking Vioxx with antacids that contain calcium carbonate and magnesium/aluminum combination products, because they may reduce the amount of Vioxx your body absorbs. What are some possible side effects of Vioxx? (This is NOT a complete list of side effects reported with Vioxx. Your health care provider can discuss with you a more complete list of side effects.) Side effects can include:
Rarely, serious ulcers have occurred in patients taking Vioxx. For more detailed information about Vioxx, ask your health care provider. Updated 10/8/99 |
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FDA Hearings on Celebrex, Vioxx Labels Could Be Crucial in Arthritis-Drug Fight By GARDINER
HARRIS
A fight between some of the world's largest drug makers will tumble into the open Wednesday when a federal advisory panel will examine whether to soften warning labels on the mega-selling arthritis drugs, Celebrex and Vioxx. Both drugs have labels that warn of ulcer-like side effects, a standard warning carried by an entire class of painkillers known as nonsteroidal anti-inflammatories (NSAIDs). These painkillers include aspirin, Advil and Aleve. But Celebrex and Vioxx were created in hopes that they wouldn't cause these side effects. Huge studies conducted recently by the drugs' makers in part support this contention. This week's panel may help determine whether the labels of Celebrex and Vioxx change to reflect these findings.
Pharmacia Inc. and Pfizer Inc., the marketers of Celebrex, appear before the panel Wednesday; Merck & Co., the maker of Vioxx, is scheduled to appear Thursday. The companies are locked in a fierce marketing war, and the meetings this week could prove to be a crucial battle. So far, the companies are evenly matched. Most physicians see the drugs as twins, and the drugs have equal shares of new prescriptions. If the advisory panel decides that one deserves a better label than the other, it could be decisive. Most analysts, however, see such an outcome as unlikely. The stakes are enormous. Celebrex had more than $2 billion in sales last year. Its launch in 1999 remains the industry's most successful drug introduction ever. Pharmacia & Upjohn Inc. bought Monsanto Co. in 1999 in large measure to acquire Celebrex. Vioxx, meanwhile, had $2.2 billion in sales last year. Its launch is the industry's second-best ever, and its success allowed Merck to avoid losing its independence through a merger. In the year and a half since Vioxx began competing with Celebrex, these companies have been shouting to doctors, patients and reporters about their own drug's benefits -- and whispering about the other drug's problems. This week, the companies get a chance to discuss the pros and cons of the drugs openly before a group of scientists who will advise the FDA about whether to change the drugs' labels. A question that is likely to go unanswered is whether Vioxx and Celebrex are worth all the money that patients spend on them. Celebrex and Vioxx cost about $2 a day; their generic rivals cost about 10 cents. The two new drugs don't cure pain better than the generics. Their sole benefit is that they are less harmful to the stomach. And only 2% to 4% of NSAID users develop gut problems such as ulcers. But so many millions rely on NSAIDs that this side-effect toll is enormous. In the U.S. alone, more than 100,000 patients are hospitalized each year with ulcer complications caused by pain pills, and about 16,500 die as a result. Preventing these complications would be of huge benefit. But an 8,000-patient study overseen by Pharmacia found that if Celebrex patients simultaneously take low-dose aspirin to protect against heart attacks, then they are just as likely to get stomach problems as those who take other pain pills. And, of course, millions of elderly users -- the most vulnerable to ulcer complications -- need low-dose aspirin for their hearts. Celebrex and Vioxx were developed after it was discovered that the enzyme controlling the pain of inflammation is distinct from the similar enzyme that protects the gut. Aspirin and ibuprofen inhibit both enzymes. Vioxx and Celebrex target just the enzyme controlling pain without interfering with the one that protects the stomach. The question before the committee this week is whether the drugs succeeded well enough that the benefits should be announced in their labels. Both drugs have side effects that will be discussed. "Anyone who suggests that the gastrointestinal NSAID warning is going to get deleted is either deluded or foolish," said Eve Slater, senior vice president of Merck's clinical and regulatory development. "But I think they will be sufficiently impressed to allow us to describe the results of these studies on our labels, and therefore allow us to use that information with patients and physicians." A label change could increase sales even more. Sidney Wolfe, a consumer health advocate, will testify Wednesday that the drugs' warning labels shouldn't be softened. FDA officials will make the final decision. Write to Gardiner Harris at gardiner.harris@wsj.com3
Updated February 7, 2001
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| Vioxx | Vioxx has the dubious distinction of 1st place in the FDA's 'top suspects' list, as having the most spontaneous adverse events reported. | ||
| Vioxx was developed as a simple NSAID that would have less potential for gastrointestinal irritation compared to aspirin, ibuprofen, naproxen, etc. |
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FDA Scrambles to Police Truthfulness of Drug Ads (Jan. 2)
