Words of Warning and Preventive Measures in Labels of Antidepressants

doi:10.19803/j.1672-8629.20240826

Abstract

Abstract: Objective To analyze the warning statements and preventive measures in the instructions of antidepressants in a tertiary mental health hospital in order to provide references for standardized wording in the instructions of antidep-ressants. Methods The frequency at which warning statements and preventive measures appeared in the instructions of antidepressants in the Affiliated Mental Hospital of Anhui Medical University from September 1 to September 30, 2022 was statistically analyzed. Results A total of 19 antidepressant instructions were included in the statistics. The total frequency of warning statements was 33, so was the total frequency of corresponding preventive measures. Among the 3 types of warning statements, the total frequency of instructions without corresponding warning statements was 10. The total frequency of complete warning statements was 17, compared with 22 for complete preventive meas-ures. Such warning statements as "Suicidal tendencies and antidepressants" appeared 30 times (90.91%), "Prohibited for patients with hepatitis B virus, hepatitis C virus, liver function impairment, or elevated transaminase levels above the normal upper limit" was used twice (6.06%), and "Prohibited for patients with epilepsy, glaucoma, urinary retention, recent history of myocardial infarction, or allergy to this product" turned up once (3.03%). The frequency of preventive measures corresponding to warning statements was 30 (90.91%) for preventive measures against "Suicidal tendencies and antidepressants", 2 (6.06%) for preventive measures related to Prohibited for patients with hepatitis B virus, hepatitis C virus, liver function impairment, or elevated transaminase levels above the normal upper limit", and 1(3.03%) for preventive measures relating to "Prohibited for patients with epilepsy, glaucoma, urinary retention, recent history of myocardial infarction, or allergy to this product". Conclusion There are inadequacies in the warning statements and preventive measures specified in instructions for antidepressants. It is recommended that related enterprises supplement the missing warning statements and preventive measures. As for the warning statements and preventive measures concerning "Suicidal tendencies and antidepressants", the age range of young patients prone to suicide should be clearly defined, and the contents of preventive measures should be improved.

Key words: Drug Instructions, Warning Statements, Preventive Measures, Suicidal Tendencies, Antidepressants, Rational Drug Use

CLC Number:

R971

ZOU Yuanlei, XIA Qingrong, LIANG Jun, HE Kongliang, MO Daming, WU Wenning. Words of Warning and Preventive Measures in Labels of Antidepressants[J]. Chinese Journal of Pharmacovigilance, 2025, 22(3): 329-333.

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References

[1] NMPA. Administrative Decree No. 202. Notice on the Issuance of Specifications for the Specifications of Chemical Drugs and Biological Products(关于印发化学药品和生物制品说明书规范细则的通知)[EB/OL].(2006-05-10)[2023-01-02].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20060510010101566_2.html.
[2] SAMR. Regulations on the administration of drug instructions and labels(药品说明书和标签管理规定)[EB/OL].(2006-03-15)[2023-01-02].https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_b1a64fa4b9314ecabadf3c6662b70c48.html.
[3] ZHANG Y, YE Y.Excavation and Evaluation of Signals of Antide-pressant-Related Suicide Adverse Events[J].Chinese Journal of New Drugs and Clinical Remedies(中国新药与临床杂志) , 2019, 38(1): 43-50.
[4] WANG XP, LIU LR, LUO QF, et al.Research Progress on Adverse Reactions of Clinical Antidepressants[J].Journal of Taizhou University(台州学院学报),2022, 44(6): 71-77.
[5] STONE M, LAUGHREN T, JONES ML, et al.Risk of Suicidality in Clinical Trials of Antidepressants in Adults: Analysis of Proprietary Data Submitted to US Food and Drug Administration[J].BMJ, 2009, 339(7718): b2880.
[6] XIE HZ, DENG XL, XIE YR, et al.Guidelines for the Diagnosis and Treatment of Mental Disorders(2020 edition)(精神障碍诊疗规范2020年版)[M].First edition. Beijing: People's Medical Publishing House, 2020: 169-171.
[7] PAN J, ZHANG W, ZHONG LT, et al.Establishment of Suicide Intervention Mechanism for Inpatients[J].Modern Hospitals(现代医院),2021, 21(5): 701-703.
[8] WANG C, XU DM, SHAO J, et al.Expert Consensus of Suicide Care Interventions for Psychiatric Inpatients with Depression[J].Chinese Journal of Nursing(中华护理杂志),2022, 57(18): 2181-2185.
[9] LIANG YZ, ZHOU FZ.Research Progress in Nursing Care of Suicidal Depression Patients[J].Internal Medicine(内科),2020, 15(1): 67-69.
[10] WANG J, CHEN L, JI ZP, et al.Risk Factors to Suicide Risk in Misdiagnosed Bipolar Disorder II Treated for Major Depressive Disorder[J].Chinese Journal of Nervous and Mental Diseases(中国神经精神疾病杂志),2015, 41(2): 65-70.
[11] MANGIONE CM, BARRY MJ, NICHOLSON WK, et al.Screening for Depression and Suicide Risk in Children and Adolescents: US Preventive Services Task Force Recommendation Statement[J].JAMA, 2022, 328(15): 1534-1542.
[12] American Academy of Pediatrics. 2022 Recommendations for Preventive Pediatric Health care[J].Pediatrics, 2022, 150(1): e2022058044.
[13] ZHANG Y, HU DY, DING XP, et al.A Meta-Analysis of the Incidence of Suicidal Ideation in Chinese Patients with Depression[J].Journal of Nursing Science(护理学杂志),2022, 37(9): 103-106.
[14] Chinese Medical Association.Guidelines for Primary Diagnosis and Treatment of Depression(2021)[J].Chinese Journal of General Practitioners(中华全科医师杂志),2021, 20(12): 1249-1260.
[15] ZWIEBEL SJ, VIGUERA AC.Discontinuing Antidepressants: Pearls and Pitfalls[J].Cleve Clin J Med, 2022, 89(1): 18-26.
[16] ZHANG B, WU H, ZHANG XM, et al.Strategies for Clinical Pharmaceutical Care Based on the Improvement of "Warnings" in Chinese Patent Medicine Instructions[J].Journal of Beijing University of Traditional Chinese Medicine(北京中医药大学报) , 2022, 45(10): 979-984.