Sensipar Label Gets Safety Update

The U.S. Food and Drug Administration has approved a change to the safety labeling of Amgen’s Sensipar (cinacalcet).

The safety label change was approved by the FDA Center for Drug Evaluation and Research (CDER). Sensipar is commonly used to treat secondary hyperparathyroidism in kidney disease patients.

The following is the safety label change as reported by the FDA:

“WARNINGS AND PRECAUTIONS

Seizures

In clinical studies, seizures (primarily generalized or tonic-clonic) were observed in 1.4% (43/3049) of Sensipar-treated patients and 0.7% (5/687) of placebo-treated patients. While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels. Therefore, serum calcium levels should be closely monitored in patients receiving Sensipar, particularly in patients with a history of a seizure disorder.

ADVERSE REACTIONS

Seizures were observed in 1.4% (13/910) of cinacalcet-treated patients and 0.7% (5/641) of placebo-treated patients across all completed placebo controlled trials.”