Physicians must not prescribe antihypertensive drugs containing aliskiren (Tekturna, Novartis Pharmaceuticals) in combination with angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) for patients with diabetes, the US Food and Drug Administration (FDA) announced today.
Patients with diabetes taking these drug combinations run the risk of renal impairment, hypotension, and hyperkalemia.
The FDA also is recommending that clinicians should avoid such drug combinations in patients with moderate to severe renal impairment.
One drug dramatically affected by the FDA's announcement is Valturna (Novartis Pharmaceuticals), which combines aliskiren and the ARB valsartan. Novartis has announced that it will cease marketing Valturna but will continue to make it available until July 20 "to enable physicians to transition patients to alternate therapies."
In addition to Tekturna and Valturna, the FDA announcement applies to other aliskiren-containing medications from Novartis:
- Tekturna HCT, which combines aliskiren and the diuretic hydrochlorothiazide;
- Tekamlo, which combines aliskiren and the calcium-channel blocker amlodipine; and
- Amturnide, which combines aliskiren, amlodipine, and hydrochlorothiazide;
The agency is revising their labels to reflect the new contraindication and warning.
The label changes are based on preliminary data from a Novartis-sponsored clinical trial called Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE), which evaluated aliskiren in combination with ACE inhibitors and ARBs. A higher risk for renal impairment, hypotension, and hyperkalemia, along with an apparent lack of efficacy, caused Novartis to halt the trial in December 2011.
The FDA noted that preliminary ALTITUDE data also demonstrate a "slight excess" in cardiovascular adverse events — stroke or death — among the patients taking aliskiren in combination with the other heart drugs. However, the agency said that it has not come to a definite conclusion about a causal link between these drugs and the cardiovascular adverse events. It will evaluate the final trial results as well as those from other aliskiren studies and share any new information that emerges.
More information about today's FDA announcement is available on the agency's Web site.
To report adverse events related to aliskiren-containing medications, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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