New Warning Requested on 19 Hypertension Drugs
Consumer advocacy group Public Citizen is petitioning federal regulators for a black box warning on 19 hypertension drugs that alerts physicians and patients to the potential for dangerous side effects when the medications are used in combination.
The drugs fall into three classes: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and aliskiren. While they are used to treat high blood pressure, they are also approved for slowing the progression of chronic illnesses such as kidney and heart disease.
ACE inhibitors and ARBs are often used in combination due to the belief that together they confer additional benefits. However, Public Citizen’s petition notes that two large studies of patients with heart disease and diabetes found the combination has no benefit and a higher rate of life-threatening side effects such as low blood pressure, kidney failure, and dangerously high blood potassium levels when compared to taking a single medication.
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 and no added patient benefit.
Public Citizen states that safety information regarding the risks of combination use needs to appear in a black box warning at the top of the labels for these drugs. Public Citizen also says in its petition that an FDA-approved medication guide should be distributed to patients as well as a “Dear Doctor” letter to physicians warning them about the risks of combination therapy.
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