Public Citizen is urging the FDA to require boxed warnings on the labels of many top-selling hypertension drugs, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and Novartis’ aliskiren, to warn against their use in combination.
When taken together in any combination, there is an increased risk of side effects such as kidney failure, low blood pressure and elevated potassium levels, the group said in a Thursday petition. Further, there is “no countervailing clinical benefit” compared with use of any of the drugs on their own, it states.
The petition also asks the FDA to:
- Require distribution of med guides with the drugs;
- Require drugmakers to send “Dear Doctor” letters about the risks; and
- Remove language in the Indications and Usage section of the labeling for Atacand (candesartan), an ARB, implying it has an “added effect” on reducing death and heart-failure hospitalizations when used with an ACE inhibitor.
Labeling remains one of the most intensely scrutinized aspects in agency inspections.
But worry not. In less than two weeks, an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders convene at the Third Annual Pharmaceutical Labeling Summit to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.
Let their expertise help you get the FDA’s OK on your next labeling change! Mark your calendar for the Summit, taking place Oct. 16-17, 2012, in Washington, D.C.