Table 2.

Summary of three reports for illustrative purposes

FAERS report number	Report priority to FDA	Initial FDA receipt date	Patient sex	Age (years)	Report type	Event summary
15992034	Expedited	21-Feb-2019	Female	55	Hospitalization	This solicited report was received by the Xyrem REMS Program for a 55-year-old female taking Xyrem for narcolepsy. She reported that she made a mistake with her Xyrem and went to the hospital. She took her first dose and then got distracted. When she went back to bed, she forgot she already took the first dose and took the second dose about 15 min apart from the first dose. She called the poison center and 911 and the poison center told her she would have to drink an entire bottle [of Xyrem] in order to have serious problems like breathing issues. Emergency Medical Services (EMS) came and they ended up leaving. Shortly after EMS leaving, she started convulsing so her husband called 911 again and EMS took her to the hospital and she was intubated. She was worried about continuing Xyrem and she was going to talk with her doctor about what to do. Upon follow-up, the prescribing physician assessed the events of convulsing and taking the first and second doses 15 min apart as related to Xyrem. The outcome for the event of convulsing was unknown
13500013	Expedited	01-May-2017	Female	53	Emergency room visit	This solicited report was received from the Xyrem REMS Program from a nurse for a 53-year-old female taking Xyrem for narcolepsy. On 23 April 2017, the patient took the first dose of 4 g of Xyrem and accidentally took the second dose of 4 g of Xyrem right after the first, without thinking. The patient was prescribed to take 3.5 g twice nightly but she had been taking 4 g twice nightly for the past 4–5 days because she had enough medication on hand. The patient reported having a hard time talking to fire medics who arrived after an ambulance was called. She didn’t remember arriving to the emergency room and hospital staff let her sleep off the Xyrem. The patient woke up 4 h later and felt loopy, groggy, and nauseated. They put her on oxygen for a little while. The physician reported labored respirations upon the patient’s arrival to the hospital. She was in the hospital for a total of 6 h. The patient reported that she was doing well and hopes to never make the same mistake again. All events resolved. No action was taken with Xyrem
14080329	Expedited	12-Oct-2017	Female	61	No medical attention required	This solicited report was received from the Xyrem REMS Program for a 61-year-old female taking Xyrem for narcolepsy. On an unknown date, the patient accidentally took the second dose of Xyrem approximately 1 h after taking the first dose because she forgot she had taken the first dose and she was half asleep when she took the second dose. The patient’s husband noted that the patient looked like she had stopped breathing. The patient discontinued Xyrem after the incident and the event of stopped breathing resolved. Follow-up information was received from a nurse that the doctor was aware of the episode of stopped breathing after the patient accidentally took her second dose approximately 1 h after taking the first dose and gave the approval that it was safe for the patient to continue Xyrem. Follow-up information was later received from the prescribing physician that greater than one year previously, the patient had taken Xyrem doses too close together and according to the patient’s husband, patient experienced hard breathing and sounded congested. She had had no further episodes and was taking divided doses at bedtime. It was also reported that patient was doing fine

FAERS United States Food and Drug Administration Adverse Event Reporting System, FDA US Food and Drug Administration, REMS risk evaluation and mitigation strategy