Safety Alerts & Recalls

What does this mean?

At this time, the FDA believes the benefits of ARBs in patients with high blood pressure and certain heart-related conditions continue to outweigh their potential risks. If you take an ARB, you should not stop taking your medicine unless told to do so by your healthcare professional. Talk to your healthcare professional if you have concerns about your medicine.

If you experience any side effects, you can report them to the FDA MedWatch program by phone at 1-800-332-1088; by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch

FDA Announces Ongoing Safety Review of Angiotensin Receptor Blockers (ARBs) for Cancer Risk

The U.S. Food and Drug Administration (FDA) is conducting a review of the class of medications known as angiotensin receptor blockers (ARBs) after a recently published study suggested they may be associated with a small increased risk of cancer. ARBs are used to treat high blood pressure, heart failure, and to reduce risk of heart disease.

The FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available.

Seven different ARBs are currently available in the U.S: candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan). ARBs are also sold in combination with other blood pressure medicines under the brand names Atacand HCT, Teveten HCT, Avalide, Hyzaar (and its generic name losartan and hydrochlorothiazide), Azor, Benicar HCT, Twynysta, Micardis HCT, Valturna, Exforge, Exforge HCT, and Diovan HCT.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-07-16
Last Updated: 2010-07-17
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