FDA Drug Safety Communication

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FDA Date: 7/14/10

Micardis (telmisartan) FDA Drug Safety Communication

Ongoing Safety Review of the Angiotensin Receptor Blockers and Cancer

FDA is conducting a review of the class of medications known as angiotensin receptor blockers (ARBs)--used to treat high blood pressure and other conditions--after a recently published study suggested they may be associated with a small increased risk of cancer.

- FDA's review is ongoing and the Agency has not concluded that ARBs increase the risk of cancer.

- At this time, FDA believes that the benefits of these medicines continue to outweigh their potential risks.

- FDA recommends that these drugs continue to be used as recommended in their approved labels.

The Agency plans to review the available data on these medications and evaluate additional ways to better assess a possible link between use of ARBs and cancer. FDA will update the public when this review is complete. At this time, FDA recommends that healthcare professionals continue to use ARBs as recommended in their product labels.

Examples of U.S.-marketed ARBs include:

Atacand (candesartan)

Avapro (irbesartan)

Benicar (olmesartan)

Cozaar (losartan)

Diovan (valsartan)

Micardis (telmisartan)

Teveten (eprosartan).

Examples of U.S.-marketed combination products include:

Atacand HCT (candesartan and hydrochlorothiazide)

Avalide (irbesartan and hydrochlorothiazide)

Azor (olmesartan and amlodipine)

Benicar HCT (olmesartan and hydrochlorothiazide)

Diovan HCT (valsartan and hydrochlorothiazide)

Exforge (valsartan and amlodipine)

Exforge HCT (valsartan, amlodipine, and hydrochlorothiazide)

Hyzaar (losartan and hydrochlorothiazide)

Micardis HCT (telmisartan and hydrochlorothiazide)

Teveten HCT (eprosartan and hydrochlorothiazide)

Twynsta (telmisartan and amlodipine)

Valturna (valsartan and aliskiren)

View the full FDA Drug Safety Communication on FDA.gov