FDA action related to medication safety labeing and warnings, August 2007

Key Points

Takeda has announced updates for the pioglitazone (Actos) label. Pioglitazone is approved as a monotherapy to lower blood glucose in type 2 diabetes and as part of combination therapy with insulin, sulfonylureas, or metformin. The updated label will include a boxed warning regarding the risk of congestive heart failure that is associated with pioglitazone treatment.

FDA has approved labeling changes for a vaccine indicated to prevent rotavirus infection (RotaTeq, Merck). The updated label includes information about reports of Kawasaki disease in children who received this vaccine.

Roche and FDA have notified healthcare professionals of labeling updates for ceftriaxone (Rocephin forInjection), which is indicated for the treatment of a variety of infections. These updates concern the potential risk associated with concomitant use of ceftriaxone with calcium or calcium-containing solutions or products. The updated prescribing information states that ceftriaxone is contraindicated in hyperbilirubinemic neonates, especially premature infants. Additionally, the warnings, precautions, adverse events, and dosage and administration sections of the product label have been updated to reflect the potential risk associated with concomitant use of ceftriaxone with calcium and calcium-containing products or solutions.