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Midazolam News
FDA Medwatch Alert: Exela Issues Voluntary Nationwide Recall of Sodium Bicarbonate 8.4%, Midazolam in 0.8% Sodium Chloride, and ELCYS Injections Due to Presence of Particulate Matter
October 25, 2023 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as s...
FDA Medwatch Alert: Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use
ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information w...
FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters
Brussels (Belgium) & Atlanta, Georgia (U.S.) – May 20 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest ant...
FDA Medwatch Alert: 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...
FDA Medwatch Alert: 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...
FDA Medwatch Alert: Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death
ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects,...