Product Liability

Blood pressure med receives black box warning

Tekturna (aliskiren) tablets, a prescription medication used to treat high blood pressure, has updated its safety label to include a new black box warning about the risk of injury and death to developing fetuses when taken by women who are pregnant or become pregnant, according to the Food and Drug Administration (FDA).

Tekturna and Tekturna HCT are marketed as an “innovative” treatment and “the first in a different class of blood pressure medications.” The medication is the only one approved that directly targets the enzyme renin to help lower blood pressure. Drugs that act directly on the reninangiotensin system have been shown to cause injury and death to developing fetuses.

When pregnancy is detected, patients are advised to discontinue Tekturna as soon as possible. If Tekturna is used during pregnancy, or if the patient becomes pregnant while taking this medication, the patient should be apprised of the potential hazard to the fetus.

Aside from the new black box warning, the safety labeling includes updates to its WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. Those warnings, precautions and adverse reactions include possible electrolyte imbalances in patients with severe renal impairment, and angioedema, or swelling of the face, lips, tongue, throat, arms, and legs which can cause difficulty breathing.

Any adverse events with this or any other medication should be reported to the FDA’s MedWatch reporting program at www.fda.gov/medwatch.