FDA Issues Warning For Aliskiren (Tekturna)

Washington, DC: The Food and Drug Administration (FDA) has issued a warning about combining the blood pressure medication Aliskiren (Tekturna) with ACE inhibitors and angiotensin receptor blockers (ARBS) in people diagnosed with diabetes or renal impairment. In addition, Novartis, the maker of Aliskiren, announced that the TekturnaR labels have been updated in the US, following the FDA's review of the preliminary findings from the ALTITUDE study.

The ALTITUDE study, which was recently terminated, found an increased risk of adverse events in patients considered high-risk and who were taking the direct renin inhibitor as an add-on to other anti-hypertensive medications such as ARBs and ACE inhibitors. The FDA said in a statement that diabetic patients who mix the drugs are at risk of renal impairment, hypotension, and hyperkalemia.

Furthermore, Novartis, in consultation with the FDA, has decided to voluntarily cease marketing in the US of ValturnaR (aliskiren and valsartan, USP), a single pill combination of aliskiren and the ARB valsartan. Valturna will no longer be marketed after July 2012.

Medications that contain aliskiren include:
Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
Tekturna (aliskiren hemifumarate)
Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
Tekamlo (aliskiren hemifumarate and amlodipine besylate)
Valturna (aliskiren hemifumarate and valsartan).

Legal Help

If you or a loved one has suffered damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Apr-20-12