U.S. Food and Drug Administration (FDA) Advisories | NGC Update Service: December 26, 2016

NGC Update Service: December 26, 2016

Announcements

U.S. Food and Drug Administration (FDA) Advisories

December 14, 2016: General Anesthetic and Sedation Drugs: FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children's brains.

Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children's brain development.

To better inform the public about this potential risk, FDA is requiring warnings to be added to the labels of general anesthetic and sedation drugs (see List of General Anesthetic and Sedation Drugs Affected by this Label Change). FDA will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available.

December 12, 2016: Pioglitazone-containing Medicines: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed.