Etomidate FDA Alerts

General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children

ISSUE: FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include:

• A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
• Addition of information to the sections of the labels about pregnancy and pediatric use to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.

General anesthetic and sedation drugs are necessary for patients, including young children and pregnant women, who require surgery or other painful and stressful procedures. In the U.S., surgeries during the third trimester of pregnancy requiring general anesthesia are performed only when medically necessary and rarely last longer than 3 hours. FDA is advising that in these situations, pregnant women should not delay or avoid surgeries or procedures during pregnancy, as doing so can negatively affect themselves and their infants.

Similarly, surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary. Consideration should be given to delaying potentially elective surgery in young children where medically appropriate.

BACKGROUND: This is an update to the MedWatch alert "General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women" issued on December 14, 2016. 

RECOMMENDATION: Health care professionals should continue to follow their usual practices of patient counseling including discussing the benefits and risks of surgeries or procedures that require general anesthesia and sedation drugs. FDA will continue to monitor the use of these drugs in children and will update the public if additional information becomes available.

Parents, caregivers, and pregnant women should talk to their health care professionals if they have any questions or concerns about general anesthesia and sedation drugs.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/27/2017 - Drug Safety Communication (Update) - FDA]
[12/14/2016 - Drug Safety Communication - FDA]

General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women

ISSUE: 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.

See the FDA Drug Safety Communication for a data summary and listing of general anesthetic and sedation drugs affected by this label change.

BACKGROUND: Anesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures, especially when they face life-threatening conditions requiring surgery that should not be delayed. In addition, untreated pain can be harmful to children and their developing nervous systems.

FDA has been investigating the potential adverse effects of general anesthetic and sedation drugs on children’s brain development since the first animal study on this topic was published in 1999. FDA held advisory committee meetings in 2007, 2011, and 2014. To coordinate and fund research in this area, FDA also formed a partnership with the International Anesthesia Research Society (IARS) called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots). More research is still needed to provide additional information about the safe use of these drugs in young children and pregnant women.

RECOMMENDATION: Health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years. Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anesthetic and sedation drugs.

Parents and caregivers should discuss with their child’s health care professional the potential adverse effects of anesthesia on brain development, as well as the appropriate timing of procedures that can be delayed without jeopardizing their child’s health. Pregnant women should have similar conversations with their health care professionals. Also talk with them about any questions or concerns.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[12/14/2016 - Drug Safety Communication - FDA]

Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date

ISSUE: Agila Specialties notified medical care organizations of a nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL (See the firm Press Release for a list of affected lot numbers). All of the products bear a Pfizer label. Product was distributed Nationwide to distributors, retailers, hospitals, pharmacies, and/or clinics.

The product was recalled due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton, and the potential for illegible/missing lot number and expiry on individual vials. Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction.

BACKGROUND: Etomidate is a hypnotic drug indicated for the induction of general anesthesia. Etomidate 2 mg/mL is packaged in glass vials in 10 mL and 20 mL volumes.

RECOMMENDATION: Mylan notified its customers of the recall by letter on Feb.13, 2014. Distributors, retailers, hospitals, pharmacies, or clinics that have product which is being recalled should stop use and discontinue distribution.

Consumers with questions regarding this recall can contact Mylan Customer Service with questions at 800.848.0462 on Monday through Friday between 8 a.m. and 5 p.m. EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

[02/19/2014 - Press Release -  Agila]