Safety Alerts & Recalls

What does this mean?

The benefits of aliskiren (Amturnide, Tekturna, Tekturna HCT, Tekamlo, and Valturna) will continue to outweigh the risks for most patients. Do not stop taking your aliskiren-containing medicine without talking to your healthcare professional. Stopping this medicine suddenly can cause problems if your high blood pressure (hypertension) is not treated.

If you have diabetes or kidney problems and you take an aliskiren-containing medicine, it is a good idea to ask your doctor to review with you the benefits and risks of your high blood pressure treatment and make changes if needed.

If you take Valturna, please be aware that Valturna will no longer be available after July 2012. Please follow up with your doctor at your next appointment so that you can be switched to a different medicine.

If you have any questions about this alert or your treatment with an aliskiren-containing medicine (Amturnide, Tekamlo, Tekturna HCT, or Valturna), you should discuss them with your doctor.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Announces New Warning and Contraindications for Aliskiren-containing Medications

The Food and Drug Administration (FDA) has notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren (known by the brand name Tekturna) with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or poor kidney function: - The combination of aliskiren with ARBs or ACEIs should not be used (is contraindicated) in patients with diabetes.

- The use of aliskiren with ARBs or ACEIs should be avoided in patients with moderate to severe kidney impairment.

The labels for the aliskiren medicines are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).” The manufacturer of Tekturna issued these warnings for diabetic patients earlier this year as described in a MediGuard Safety Alert in January 2012: more information here

Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension). The following medicines contain aliskiren alone or in combination with other medicines: Amturnide, Tekturna, Tekturna HCT, Tekamlo, and Valturna. Please note, Novartis (the manufacturer of aliskiren-containing products) has decided to stop marketing Valturna, a combination drug product containing aliskiren and the ARB drug valsartan, but will ensure that Valturna is available until July 2012 so that heathcare professionals can change patients to other therapy.

Examples of ACE inhibitors and ACE inhibitor combinations available in the United States are: Benazepril (Lotensin, and the combinations Lotrel, Lotensin HCT), Captopril (Capoten, and the combination Capozide), Enalapril (Vasotec and the combination Vasoretic), Fosinopril, Lisinopril (Prinivil, Zestril and the combinations Prinzide, Zestoretic), Moexipril (Univasc and the combination Uniretic), Perindopril (Aceon), Quinapril (Accupril and the combinations Accuretic, Quinaretic), Ramipril (Altace), and Trandolapril (Mavik and the combination Tarka).

Examples of ARBs and ARB combinations available in the US are: Candesartan (Atacand and the combitation Atacand HCT), Eprosartan (Teveten and the combination Teveten HCT), Irbesartan (Avapro and the combination Avalide), Losartan (Cozaar and the combination Hyzaar), Olmesartan (Benicar, and the combinations Azor, Benicar HCT, Tribenzor), Telmisartan (Micardis and the combinations Micardis HCT, Twynsta), and Valsartan (Diovan and the combinations Diovan HCT, Exforge HCT, Valturna).

For more information, please visit: more information here

Source: FDA
Publication Date: 2012-04-23
Last Updated: 2012-04-23
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