Now, Celebrex, the only Cox-2 inhibitor still available, carries a prominent “black box warning” on its packaging—the U.S. Food and Drug Administration’s strongest warning—that it may be linked to an increased risk of cardiovascular events.
In 2005, the FDA also announced new label requirements for prescription and nonprescription NSAIDs. Now, their packaging includes the same black box warning as the Cox-2 inhibitors. The warning highlights the increased risk of heart attack and stroke, as well as the potential for gastrointestinal bleeding. Manufacturers of Celebrex and all other prescription NSAIDs have since revised their labeling to include a medication guide for patients to ensure they use these drugs properly.
Take Precautions With NSAIDs
To ensure that NSAIDs are taken safely, patients should use them with a doctor’s supervision. They carry certain risks and may cause or worsen medical problems if taken at the same time as other medications or if certain health conditions are present. For example, individuals who are taking anticoagulants, such as warfarin sodium (Coumadin®), should be monitored for the potential of increased bleeding. A doctor’s supervision is also necessary because NSAIDs may cause fluid retention, which can decrease the effectiveness of high blood pressure medication and diuretics.
Many patients with rheumatoid arthritis take methotrexate, and its toxicity may increase when NSAIDs are used. Because corticosteroids and high doses of aspirin may increase the risk of developing peptic ulcers or gastrointestinal bleeding, a condition which can be aggravated by NSAID use, caution is advised. Some NSAIDs can also interfere with aspirin, which is sometimes taken to prevent heart disease.
People with certain health conditions should not take NSAIDs. Those conditions include an allergy to NSAIDs, peptic ulcer disease, bleeding disorders and kidney function impairment. Pregnant women are also told to avoid using NSAIDs during the last three months of their pregnancy.
Finally, patients should call their health professional if they experience severe stomach pain, bloody vomit, bloody or black tar-like stools, bloody or cloudy urine, unexplained bruising or bleeding, wheezing or breathing troubles, swelling in the face or around the eyes, severe rash or red, itchy skin. These conditions require immediate medical consultation.