The consumer advocacy group Public Citizen has charged the US Food and Drug Administration (FDA) with failing to warn patients of the dangers of using combination therapies involving 3 drug classes for the treatment of hypertension. The organization has petitioned the FDA to add a black box warning to the labels of these medications and to write a “Dear Doctor” letter to physicians alerting them to the potential dangers of such combination therapy.
At issue are medications containing angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and the direct renin inhibitor aliskiren. Individually, these medications do lower blood pressure, and it was theorized that combining the therapies could confer a synergistic benefit in patients with hypertension and other conditions, such as chronic kidney disease. Indeed, such benefits are seen in many patients given combination therapy often involving a thiazide-type diuretic and another hypertension treatment medication. Combining ACE inhibitors and ARBs has been shown to be effective in reducing proteinuria and reducing cardiovascular death or hospital admissions in patients with chronic heart failure. But otherwise, studies appearing over the past decade not only have shown no benefit to this approach, but also have identified increased risk for adverse events, prompting Public Citizen's petition.
Mitka M. Consumer Group Asks FDA to Warn Patients About Hypertension Combination Therapy. JAMA. 2012;308(20):2070-2071. doi:10.1001/jama.2012.25362