BURG SIMPSON IS NOT PURSUING NEW SPRAVATO CASES
Janssen Warns Its Drug Spravato Can Cause Respiratory Depression and Respiratory Arrest
On October 18, 2023, the manufacturer of Spravato (Janssen Pharmaceuticals) added warnings to its label telling U.S. consumers for the first time that its drug could cause respiratory depression and respiratory arrest. If improperly treated, these conditions can be deadly.
Spravato is a nasal spray used to treat depression. The main ingredient in Spravato – esketamine – is derived from the anesthetic ketamine. In other countries, Janssen warned that the use of eskatamine and ketamine could cause respiratory depression. Janssen, however, failed to warn patients in the United States of Spravato’s risk of respiratory depression until October 2023 – only after receiving dozens of reports of respiratory depression, including incidents of respiratory arrest.
What is Spravato and How is it Administered?
Spravato is a nasal spray prescribed to patients suffering from treatment resistant depression. Spravato is not to be used at home. Rather, the drug must only be administered under the direct supervision of a healthcare provider. Patients taking Spravato are to be monitored for at least two hours after receiving a dose; however, it was not until October 2023 that Janssen informed patients and doctors to watch for signs of respiratory depression and respiratory arrest.
What is Respiratory Depression and Respiratory Arrest?
Respiratory depression is a condition where breathing can become slow, difficult, and/or ineffective at delivering oxygen to the body. This can lead to a buildup of carbon dioxide in the blood, which can cause symptoms that include headaches, confusion, and blue coloration to the skin. If left untreated, a patient may stop breathing (respiratory arrest) and die.