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Oct. 4, 2012  

Widely Used Blood Pressure Drugs Should Include a Strong Warning Against Use of Drugs in Combination, Public Citizen Tells FDA

Public Citizen Calls on FDA to Require Black Box Warning on Labels of 19 Hypertension Drugs

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should place a black box warning on three classes of drugs used to treat high blood pressure (hypertension), cautioning doctors and patients against the use of the drugs in combination, Public Citizen said in a petition sent today to the agency.

The drugs, known as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and aliskiren, are commonly used to treat high blood pressure. Several ACE inhibitors and ARBs also are approved for, and effective when used separately in, slowing the progression of other chronic illnesses, such as heart and kidney disease that afflict millions of people.

ACE inhibitors and ARBs are among the top-selling medications in the country. In 2011, 164 million ACE inhibitor prescriptions (fifth most of any drug class) and 86 million ARB prescriptions (16th most) were dispensed (in addition to 2.4 million aliskiren prescriptions). ARBs alone generated $7.6 billion in revenue in 2011.

The use of ACE inhibitors and ARBs in combination has become commonplace in recent years due to a theoretical belief that such combination use would confer an added benefit over the use of the drugs individually. However, this theory has been unequivocally disproven in two large studies involving tens of thousands of patients with heart disease and diabetes that failed to show any clinical advantage of combination therapy. On the contrary, the studies showed a higher rate of several life-threatening side effects, such as low blood pressure, kidney failure and dangerously high blood potassium levels, in patients taking the drugs together compared with patients on only one of the medications.

A third study involving the combined use of the new drug aliskiren with ACE inhibitors and ARBs in patients with diabetes and kidney disease was halted early for identical reasons: a higher rate of the same serious side effects with no added benefit with combination use. An aliskiren/ARB combination drug, Valturna, was withdrawn from the market shortly thereafter.

Despite this wealth of data, the FDA has failed to respond by adequately warning doctors and patients of the clear danger of the combined use of ACE inhibitors, ARBs and aliskiren, Public Citizen said in the petition. Critical safety information to this effect does not appear in a black box warning at the top of any of the drugs’ labels, and for most of the drug labels, there is no mention anywhere of the dangers of combined use.

“There are few cases in medicine that have such a vast body of evidence all pointing in the same direction,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “This is a classic case of theory not translating into clinical significance. Patients with serious conditions, such as heart and kidney disease, should never be exposed to life-threatening side effects, unless the benefits outweigh the risks. This is clearly not the case here. The FDA must act accordingly and alert the medical community and the users of these drugs of this critical danger.”

Public Citizen calls on the FDA to add a black box warning to the labels of all 18 ACE inhibitor and ARB medications, as well as aliskiren, indicating the increased risk of serious side effects with no added benefit when using the drugs in combination. Public Citizen also is petitioning the agency to require an FDA-approved medication guide to be distributed to all patients prescribed these drugs, as well as a “Dear Doctor” letter to physicians, warning them of the dangers of combination therapy.

To read the petition, visit http://www.citizen.org/hrg2075.

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