Micardis Tagged by FDA for Suspicion of Slight Cancer Risk


. By Gordon Gibb

nation's drug supply, the US Food and Drug Administration (FDA) has taken the findings of a study recently published in The Lancet and has decided to review angiotensin receptor blockers (ARB) in view of a suspicion for an elevated cancer risk. Among the drugs the FDA has identified for closer scrutiny is Micardis, a blood pressure medication that is being reviewed for a slight risk of Micardis cancer.

It should be noted that the FDA, in its July 15th safety notice, was careful to point out that in its view the benefits of Micardis continue to outweigh any potential risks at present, and that patients should continue to use the medication according to current product labels and prescribing information.

In other words, don't go running to the hills just yet over the potential for Micardis side effects. This is just a cautionary note—but caution just the same.

According to the text of the FDA safety alert posted on the agency's official website, a meta-analysis of randomized controlled trials conducted by researchers at Case Western Reserve University School of Medicine in Cleveland, Ohio "suggests that ARBs are associated with a modestly increased risk of new cancer diagnosis," according to the interpretation of the researcher's findings published in Volume 11, Issue 7 of The Lancet Oncology (July, 2010).

"Given the limited data, it is not possible to draw conclusions about the exact risk of cancer associated with each particular drug. These findings warrant further investigation."

The published study reported data from more than 1,000 patients in several long-term clinical trials. The data showed a slightly higher frequency of new cancer among patients using one of the blood pressure drugs, compared with patients who did not, according to the FDA, and concluded that no statistically significant difference in the number of cancer deaths was observed.

Still, the agency maintains, the possibility that Micardis could pose a hazard warrants further study. Even the possibility, however remote, of increased risk for cancer from the use of Micardis telmisartan is naturally a concern for patients suffering from hypertension (high blood pressure). Given the size of the American population having blood pressure issues, any potential threat posed by the potential side effects of Micardis and the related concern is valid.




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