In July 2010, the FDA reported that a safety review of ARBs would be performed after a published study found a small increased risk of cancer in patients taking an ARB compared to those patients not taking an ARB.
For this safety review, the FDA evaluated 31 randomized clinical trials, comparing patients taking an ARB to patients not taking an ARB, looking for the incidence of cancer.
“The FDA has completed its review of controlled trial data on more than 155,000 patients randomized to ARBs or other treatments–the largest evaluation of such data to date–and finds no evidence of an increased risk of cancer in patients who take an ARB,” said Mary Ross Southworth, Pharm. D., deputy director for safety in the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
ARBs are medications used alone or in combination with other medications to treat high blood pressure and other heart-related conditions. A complete list is available in a Drug Safety Communication issued today.
Brand names include:
• Atacand (candesartan)
• Avapro (irbesartan)
• Benicar (olmesartan)
• Cozaar (losartan)
• Diovan (valsartan)
• Micardis (telmisartan)
• Teveten (eprosartan)
• Several combination drug products
Sustained elevated blood pressure (hypertension) increases the risk of death, heart attacks, stroke, heart failure and kidney failure. That is why it is important to keep blood pressure at normal levels. There are many treatments available to control elevated blood pressure and ARBs are an important group of such treatments.
The FDA has determined that any concern about a relationship between ARB use and development of cancer has been resolved by this analysis. People currently taking any antihypertensive medication should not stop taking it without talking to their health care professional first.
Adverse events associated with ARB medications should be reported to the FDA MedWatch program at www.fda.gov/medwatch.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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