Black Box text: Use of TRACLEER® requires attention to two significant concerns: 1) potential for serious liver injury, and 2) potential damage to a fetus. WARNING: Potential liver injury TRACLEER® causes at least 3-fold (upper limit of normal; ULN) elevation of liver aminotransferases (ALT and AST) in about 11% of patients, accompanied by elevated bilirubin in a small number of cases. Because these changes are a marker for potential serious liver injury, serum aminotransferase levels must be measured prior to initiation of treatment and then monthly. [Please see link at bottom for full black box warning on potential liver injury]. CONTRAINDICATION: Pregnancy TRACLEER® (bosentan) is very likely to produce major birth defects if used by pregnant women, as this effect has been seen consistently when it is administered to animals (see CONTRAINDICATIONS). Therefore, pregnancy must be excluded before the start of treatment with TRACLEER® and prevented thereafter by the use of a reliable method of contraception. Hormonal contraceptives, including oral, injectable and implantable contraceptives should not be used as the sole means of contraception because these may not be effective in patients receiving TRACLEER® (see Precautions: Drug Interactions). Monthly pregnancy tests should be obtained. Because of potential liver injury and in an effort to make the chance of fetal exposure to TRACLEER® (bosentan) as small as possible, TRACLEER® may be prescribed only through the TRACLEER® Access Program by calling 1-866-228-3546. Adverse events can also be reported directly via this number.

The new FDA alert indicates that Tracleer may also cause changes in the blood, can result in fluid retention among people suffering from congestive heart failure, and may interact in harmful ways with certain drugs. If you're taking this medication, please print out the FDA alert and discuss it with your doctor.

www.fda.gov/medwatch/SAFETY/2003/03Oct_PI/Tracleer_PI.pdf

Patients:

Tell your doctor if you are hypersensitive to any ingredient in the tablet

Talk with your doctor if you're taking both calcium channel blockers and beta-blockers

Talk with your doctor if you have peripheral vascular disease

Alert your provider to the labeling change concerning liver disorders as well as monoamine inhibitors (MAOIs)

The Food and Drug Administration announced the following safety labeling changes for Toprol-XL:

Toprol should not be used in anyone hypersensitive to any ingredient in the tablets.

Peripheral vascular disease: Beta-blockers can… aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in such individuals.

Caution should be used in patients treated with [calcium channel blockers and beta-blockers of the verapamil and diltiazem type]."

Patients:

Do not take Procardia with grapefruit juice

The Food and Drug Administration announced safety labeling changes for Procardia in February 2002. These included a warning not to take the medication with grapefruit juice, because it boosted concentrations in the blood to unhealthy levels. The FDA also suggested that doctors start patients aged 65 or older at the low end of the dosing range.

The Food and Drug Administation posted the following labeling changes for Viagra:

"Physicians should advise patients that simultaneous administration of Viagra doses above 25 mg and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, Viagra doses above 25 mg should not be taken within four hours of taking an alpha-blocker.

Patients with the following underlying conditions can be particularly sensitive to the actions of vasodilators including Viagra -- those with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure."

First published October 29, 2003
Copyright © 2003 Consumer Health Interactive

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