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FDA issued two important drug warnings this week: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy.
FDA recently issued 2 drug warnings: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy and in young children.
FDA’s new Drug Safety Communication warns that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than age 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,” FDA said in the Drug Safety Communication.
FDA is now requiring warnings to be added to the labels of general anesthetic and sedation drugs, including lorazepam injection (Ativan) and propofol (Diprivan). “We will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available,” FDA said.
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Meanwhile, FDA also warned that pioglitazone-containing medications (including Actos, Actoplus Met, Actoplus Met XR, Duetact and Oseni) for type 2 diabetes may be linked to an increased risk of bladder cancer. “The labels of pioglitazone-containing medicines already contain warnings about this risk, and we have now approved label updates to describe the additional studies we reviewed,” FDA said in the Drug Safety Communication.
Although FDA alerted the public about the possible risk of bladder cancer associated with the drugs in September, 2010, and June, 2011, based on interim results from a 10-year epidemiologic study, it recently conducted an updated review.
“Health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer,” FDA said.