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FDA Probing Possible Cancer Link to Popular Blood Pressure Drugs

Jul 15, 2010 | Parker Waichman LLP

U.S. health regulators are conducting a safety review of angiotensin-receptor blockers (ARBs) after a study suggested commonly prescribed blood pressure medicines could be associated with an increased risk of cancer. ARBs are sold under various brand names, Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.

In addition to treating high blood pressure, ARBs may also be used to treat heart failure, as well as kidney failure in people with diabetes or high blood pressure. They may also prevent diabetes and reduce the risk of stroke in patients with high blood pressure and an enlarged heart. ARBs may also prevent the recurrence of atrial fibrillation. They are often are used when ACE inhibitors are not tolerated by patients.

According to a notice posted on the Food & Drug Administration (FDA) Web site, a meta-analysis that included data from over 1,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs reported the frequencies of new cancer occurrence to be 7.2 percent for patients receiving ARBs compared to 6.0 percent for those not receiving ARBs. The mean duration of follow-up ranged from 1.7 to 4.8 years.

The FDA alert pointed out that the clinical trials in the meta-analysis were not designed to study the effects of ARBs on cancer risk. The FDA said the findings need close examination for more detailed information about the patients who were reported to have cancer so that it can be determined whether this cancer was in fact new.

The agency said it has not yet concluded that ARBs increase the risk of cancer. Once complete, the FDA’s review will provide additional information about the possible link between ARB use and development of cancer. At this time, the agency recommends that healthcare professionals continue to use ARBs as recommended in their product labels. Patients should not stop taking their medication unless told to do so by their healthcare professional.

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