Regulatory Focus™ > News Articles > Group Calls for REMS-Like Conditions for Popular Hypertension Drugs

Group Calls for REMS-Like Conditions for Popular Hypertension Drugs

Posted 05 October 2012 | By Alexander Gaffney, RAC 

The public safety advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to place additional safety warnings and restrictions on several classes of hypertension drugs due to safety concerns.

In a petition sent to FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock on 4 October, Public Citizen said three types of hypertension drugs-angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and aliskiren-are dangerous when used in combination with one another.

The drugs are widely prescribed and used, the group said. An estimated 164 ACE inhibitor prescriptions and 86 million ARB prescriptions were dispensed in 2011, with millions of patients using the two drugs together.

The drugs, "Present an increased risk of renal failure, symptomatic hypotension and hyperkalemia, with no countervailing clinical benefit compared with any of the drug classes used alone," the group wrote. "At present, combination therapy is addressed, wholly inadequately, in the labels of [six] or the 18 ACE inhibitor/ARB drugs, and the warnings on these six drugs are dangerously insufficient."

The group is calling for the "mandatory distribution" of Medication Guides, Dear Doctor letters and black box warnings-all core components of Risk Evaluation and Mitigation Strategy (REMS) plans instituted under the FDA Amendments Act of 2007-for all three drug classes. In addition, Public Citizen said it demands numerous changes to the Indications and Usage section of the labeling of candesartan, an ARB. The group contends the label contains a statement indicating it benefits patients when used with an ACE inhibitor-a claim it says is, "based on a non-standardized clinical trial." Further, more rigorous testing has contradicted these claims, Public Citizen explained.

Despite a number of large clinical studies, the group said FDA had, "Failed to respond by adequately warning doctors and patients of the clear danger of the combined use" of the drugs, wrote Public Citizen in a statement.

"There are few cases in medicine that have such a vast body of evidence all pointing in the same direction," said Sammy Almashat, a researcher with Public Citizen. "FDA must act accordingly and alert the medical community and the users of these drugs of this critical danger."

Public Citizen's petition has not yet been acknowledged by FDA, which usually does so in the Federal Registerseveral days after receipt of the letter.


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