U.S. Food and Drug Administration Advisories

FDA Drug Safety Communication: FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug classIncludes potential for abuse, addiction, and other serious risks (September 2020) — To address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions, the U.S. Food and Drug Administration (FDA) is requiring the Boxed Warning be updated for all benzodiazepine medicines. Benzodiazepines are widely used to treat many conditions, including anxiety, insomnia, and seizures. The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately. This increases these serious risks, especially when benzodiazepines are used with some other medicines and substances.

Benzodiazepines can be an important treatment option for treating disorders for which these drugs are indicated. However, even when taken at recommended dosages, their use can lead to misuse, abuse, and addiction. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs. Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening.

The new warnings in the labeling were not implemented until February 2021.

FDA Drug Safety Communication: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR (January 2013 revised May 2013) — The U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs.

FDA is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR) — either 6.25 mg or 12.5 mg — should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities. This new recommendation has been added to the Warnings and Precautions section of the physician label and to the patient Medication Guide for zolpidem extended-release (Ambien CR).

FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses (revised March 2012) — Citalopram use at any dose is discouraged in patients with certain conditions because of the risk of QT prolongation, but because it may be important for some of those patients to use citalopram, the drug label has been changed to describe the particular caution that needs to be taken when citalopram is used in such patients. The revised drug label also describes lower doses that should be used in patients over 60 years of age.

Children born to mothers who took Valproate products while pregnant may have impaired cognitive development (June 2011) — [The] FDA is informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.

FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns (February 2011) — The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that it has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

Suicidality in Children and Adolescents Being Treated With Antidepressant Medications (May 2018) — Today the Food and Drug Administration (FDA) directed manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and to include additional information about the results of pediatric studies..

Many of the earlier warning contained on this page have been removed or replaced by the FDA including:

• Zolpidem Containing Products: Drug Safety Communication — FDA Requires Lower Recommended Doses (including Ambien, Ambien CR, Edluar, and Zolpimist) (January 2013)
• Suicidality in adults being treated with antidepressant medications (June 2005)
• Deaths with antipsychotics in elderly patients with behavioral disturbances (April 2005)
• Suicidal thinking in children and adolescents for attention deficit disorder for Atomoxetine (marketed as Strattera) (September 2005)
• Suicidality in children and adolescents being treated with antidepressant medications (October 2004)