•  Rheumatoid Arthritis Center

The Food and Drug Administration (FDA) has added its black box warning to the label of Bextra-valdecoxib tablets. The FDA has also added warnings to the label regarding use of Bextra following Coronary Artery Bypass Graft Surgery (CABGS).

The new black box warning reads as follows:

Serious Skin Reactions

Serious skin reactions (e.g., toxic epidermal necrolysis, Sevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving BEXTRA. Some of these reactions have resulted in death.

Patients appear to be at higher risk for these events within the first 2 weeks of treatment, but these may occur at any time during treatment.

The reported rate of these serious skin events appears to be greater for BEXTRA as compared to other COX-2 agents.

Bextra should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Additionally the FDA has added the following to the warning label:

Coronary Artery Bypass Graft Surgery

Patients treated with BEXTRA for pain following CABGS have a higher risk for cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications. BEXTRA is therefore contraindicated for the treatment of postoperative pain following CABG surgery.

Because of the growing concern about COX-2 inhibitors, the FDA has also provided a “talk paper” and questions and answers at the link below. You may print them out and discuss them with your doctors.

www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Bextra

The FDA and Abbott Pharmaceuticals notified healthcare professionals of revisions to the WARNINGS section of the prescribing information for Humira, indicated for the treatment of rheumatoid arthritis. These warnings include serious infections with the combined use of Humira (adalimumab) and anakinra, hypersensitivity reactions, including anaphylaxis [shock], and [liver problems], including pancytopenia and aplastic anemia. For more information, go to the link below, print out the material and discuss it with your doctor.

www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Humira

The FDA and Centocor notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for Remicade, indicated for the treatment of rheumatoid arthritis and Crohn's disease. In controlled studies, including Remicade, more cases of lymphoma have been observed among patients receiving the agents than among control group patients.

Malignancies have also been observed in open-label, uncontrolled clinical studies at a rate several-fold higher than expected in the general population. Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma.

For more information, go to the following link:

www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Reminyl

In September 2004, the manufacturer of Vioxx, a popular COX-2 inhibitor used in arthritis treatment, voluntarily removed the drug from the market after reports that long-term use increased the risk of stroke and heart attack in some people. A large study by researchers at Vanderbilt University found that people on higher doses (50 mg) of Vioxx, were almost twice as likely to develop heart disease or suffer heart attacks when compared to those taking other NSAIDs or 25 mg doses of Vioxx. According to the U.S. Food and Drug Administration, further studies bore out the evidence of increased cardiovascular risks. For more information, print out a copy of the following link and discuss it with your doctor. www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx

Black box warning:"Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. Each patient should remain constantly under the close supervision of the physician. Patients should be warned to report promptly any symptoms suggesting toxicity." A safety alert for Cuprimine by the Food and Drug Administration indicates that its use by people with certain diseases, such as aplastic anemia, agranulocytosis, and myasthenia gravis, has been associated with fatalities in some cases. The drug has also been associated with serious adverse blood and kidney reactions. For more information, print out a copy of the full warning and discuss it with your doctor. www.fda.gov/medwatch/SAFETY/2003/03NOV_PI/Cuprimine_PI.pdf

The FDA alert advises doctors to consider telling patients to use folate supplements to reduce the possibility of developing mouth sores as a result of taking Rheumatrex. Because of lack of study of the effects of Rheumatrex on people over the age of 65, the new alert advises doctors to prescribe lower doses in order to prevent potential kidney and liver function problems.www.fda.gov/medwatch/SAFETY/2003/03Oct_PI/Rheumatrex_PI.pdf

Black Box warning: Contraindications and warnings: Pregnancy must be excluded before the start of treatment with Arava. Arava is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. (see contraindications and warnings.) Pregnancy must be avoided during Arava treatment or prior to the completion of the drug elimination procedure after Arava treatment. The FDA alert reports that in certain cases, Arava has been associated with liver injury and fatalities. Patients using Arava are advised to have biannual blood tests and if used with some other medications such as methotrexate, blood monitoring should be done monthly. To print out the entire document to discuss with your doctor, click here:www.fda.gov/medwatch/SAFETY/2003/Arava_PI.pdf

The new drug safety alert posted by the FDA advises that doctors should be cautious about giving Cytotec to patients with pre-existing cardiovascular conditions. Chest pain, fluid retention and irregular heartbeat are some of the reported adverse reactions to taking Cytotec. To print out this safety alert to discuss with your doctor, click here.www.fda.gov/medwatch/SAFETY/2003/03AUG_PI/Cytotec_PI.pdf

The FDA's safety alert indicates that Orudis and Oruvail may cause kidney problems in those who are taking it. Doctors should also consider lowering the dosage of the drug for patients over the age of 75 and more closely monitor their kidney function. To read the complete FDA posting, click here:www.fda.gov/medwatch/SAFETY/2003/03AUG_PI/Orudis_PI.pdf

Rare cases of hypersensitivity and skin reactions in patients who take BEXTRA (valdecoxib tablets) have led Pharmacia and Pfizer to change the warning label on the drug, typically used to treat the symptoms of adult rheumatoid arthritis and osteoarthritis, according to the Food and Drug Administration (FDA). Since the drug was approved by the FDA in late 2001, rare cases of anaphylactic reactions and of serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Some cases were serious and/or life-threatening and occurred in patients who had no history of allergic-type reactions to sulfonamides. The new labels indicate BEXTRA should not be given to patients with a history of allergic reactions to sulfonamides and should be discontinued at the first appearance of skin rash or other signs of hypersensitivity. For more information, contact Pharmacia at (800) 253-8600, ext. 38244, or the FDA's MedWatch at (800) FDA-1088.

The Food and Drug Administration approved the drug Vioxx (rofecoxib), already approved for the treatment of osteoarthritis, for treating rheumatoid arthritis. The decision came after a clinical study of 4,000 patients showed that a 50 mg/day dose of Vioxx presents 50 percent less risk of serious gastrointestinal (GI) problems like major bleeding, perforation, and obstruction compared to a 1,000 mg/day dose of naproxen (Advil, Motrin, Aleve, etc.), according to the FDA. However, the FDA pointed out, the same study showed that nearly three times as many people in the Vioxx group experienced heart attacks, angina pectoris, clots, and other heart-related adverse events than people in the naproxen group.

A 2001 study published in the Journal of the American Medical Association (JAMA) also reported that people taking Vioxx or Celebrex (celecoxib) for arthritis were twice as likely to have heart attacks as those taking aspirin-like medicine for the condition. The FDA also approved new labeling information for Vioxx that notes the possible increased risk of cardiovascular problems. The new labels advise physicians to use caution in prescribing the drug to patients with ischemic heart disease.

First published July 21, 2003
Copyright © 2003 Consumer Health Interactive

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