Does Sertraline have a black box warning? (+5 factors)
By
Ivan Kahwa
Author bio
Mr Ivan Kahwa is a chemist and phytopharmaceutical scientist with expertise in chemistry, pharmacology, phytochemistry, and Nanobiotechnology. He writes and reviews content on these topics.
Mr Ivan Kahwa’s Highlights:
Guest Researcher at the University of Leipzig, Senior Research Fellow/Scientist, and Lecturer at the Department of Pharmacy, Faculty of Medicine, Mbarara University of Science and Technology.
Professional Experience:
Mr Ivan joined PHARMBIOTRAC as a research fellow/scientist during his master of science tenure. He contributed to the development of most of the phytopharmaceutical products in the project. Furthermore, he participated in carrying out the pharmacological activities of the developed products in laboratory animals such as mice and rats in order to develop proper doses hence leading to pre-clinical studies.
With the above relevant research experience, Ivan started to work with the University of Leipzig on collaborative projects with Mbarara University to develop the chemistry of Ugandan Medicinal plants and their pharmacological activities. This was coupled with several consultative positions by different German NGOs. Mr. Kahwa is also a supporting in the teaching and learning at the Departments of Pharmacy and Pharmaceutical Sciences, Faculty of Medicine, Mbarara University of Science and Technology.
With the increase in antimicrobial resistance globally, Ivan retooled his thinking towards developing new naturally derived antibiotic regimens from Ugandan propolis with the assistance of nanotechnology to improve their delivery to microbial cells. Kahwa has also published over 28 articles in peer-reviewed journals and he is currently reviewing for many journals.
Education:
2023-2027: PhD in Pharmaceutical Sciences (ongoing) with a focus on Pharmaceutical Microbiology and Nanobiology at Mbarara University of Science and Technology.
2022: 2Msc. in Pharmacognosy and Natural Medicine Science at Mbarara University of Science and Technology.
2018: Bachelor of Science (Chemistry) at Mbarara University of Science and Technology.
Publications:
▪ Iqbal, S., Jabeen, F., Kahwa, I., & Omara, T. 2023. Suberosin Alleviates Thiazolidinedione-Induced Cardiomyopathy in Diabetic Rats by Inhibiting Ferroptosis via Modulation of ACSL4-LPCAT3 and PI3K-AKT Signaling Pathways. Cardiovascular Toxicology. https://doi.org/10.1007/s12012-023-09804-7
▪ Gupta, A. K., Yadav, R., Sharma, S., Sawale, J., & Kahwa, I. 2023. Anti-ageing Activity and Antioxidant Activity of Methanol Extracts of Leaves and Flowers of Salvia officinalis and Rosmarinus officinalis. Journal of Young Pharmacists, 15(3), 448–455. https://doi.org/10.5530/jyp.2023.15.60
▪ Tolo, C.U., Kahwa, I., Nuwagira, U., Weisheit, A. and Ikiriza, H., 2023. Medicinal plants used in treatment of various diseases in the Rwenzori Region, Western Uganda. Ethnobotany Research and Applications, 25, pp.1-16.
https://ethnobotanyjournal.org/index.php/era/article/view/4683
▪ Kahwa, I., Ajayi, C.O., Yadav, R., Chauhan, N.S., Shah, K., Abdelgadir, A.A., Shegena, E.A., Daniel, S., Omara, T., Asiimwe, J.B. and Ikiriza, H., 2023. Pharmacognostic and phytochemical studies as an invaluable approach for correct identification of medicinal plants: The case of Artemisia vulgaris L. substituted for Artemisia annua L. in Western Uganda. TMR Integr Med, 7, p.e23004.
https://doi.org/10.53388/TMRIM202307004
▪ Nalimu, F., Oloro, J., Kahwa, I. and Ogwang, P.E., 2021. Review on the phytochemistry and toxicological profiles of Aloe vera and Aloe ferox. Future Journal of Pharmaceutical Sciences, 7, pp.1-21.
https://doi.org/10.1186/s43094-021-00296-2
▪ Elamin, O.H.S., Ali, M.A., Elgezuli, I.A.A., Bashir, M.A. and Kahwa, I., 2021. Diagnosis of pre-and post-treatment of echinococcus granulosus with counter current immune electrophoresis and bacterial co-agglutination. Journal of Microbiology and Infectious Diseases, 11(02), pp.88-94.
https://doi.org/10.5799/jmid.951600
Published book Chapter
▪ Kahwa, I., Ayesiga, I., Nakalema, S., Alinaiswe, R., Mbabazi, R. and Iqbal, S., 2023. Natural products in the management of onchocerciasis. In Natural Products in Vector-Borne Disease Management (pp. 63-80). Academic Press. Book Chapter.
https://doi.org/10.1016/B978-0-323-91942-5.00012-4
Submitted manuscripts Under Review:
▪ Comparison of the Wound Healing Activity of the Leaf and Leaf Ash Extracts of Vernonia amygdalina in Rats. Journal name: Clinical Phytoscience
▪ Ethnobotanical Survey of Medicinal plants used in the management of cancer in Uganda. Journal name: Journal of Herbal Medicine
▪ Ethnobotanical survey and phytochemical screening of medicinal plants used in treatment of epilepsy by PROMETRA-Uganda Traditional Health Practitioners in Mpigi District, Uganda. Journal name: Journal of Ethnopharmacology
Submitted book chapters under review
1.Book title: Algae as a Natural Solution for Water-Food-Energy Nexus, Section 4: Microalgae and cyanobacteria for food applications, Chapter 4.6: Safety, toxicological and allergenic aspects of using algae for food. Authors: Christine Kyarimpa, Tom Omute, Caroline K. Nakiguli, Alice V. Khanakwa4, Christopher Angiro, Ivan Kahwa, Fortunate Ahumuza, Timothy Omara*. Publisher: Springer Nature Singapore Pte Ltd. 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore.
2.Book title: Nutraceuticals Inspiring the Contemporary Therapy for Lifestyle Diseases. Chapter: Nutraceutical applications of Seaweeds and their Phytocompounds in Nutrition and Treatment of Diseases. Authors: Ivan Kahwa, Timothy Omara , Innocent Ayesiga , Gael Noel Neh Neba Ambe , Zehbanaz Javidbhai Panwala , Rachel Mbabazi , Shabnoor Iqbal , Christine Kyarimpa , Christine Betty Nagawa , Kamal Shah ,Nagendra Singh Chauhan* Publisher: CRC Press
You can view my works on the following professional sites:
Research Gate: https://www.researchgate.net/profile/Ivan-Kahwa
Google Scholar: https://scholar.google.com/citations?user=tOwrvqoAAAAJ&hl=en
ORCID: https://orcid.org/0000-0002-6440-3437
Linkedin: https://de.linkedin.com/in/ivan-kahwa-865450159
In this article, we will discover if Sertraline is given a black box warning or not. We will further dig deep into the side effects associated with Sertraline due to which it has been given a black box warning. We will also look at the precautions to avoid these effects.
Does Sertraline have a black box warning?
Yes, Sertraline has a black box warning. The Food and Drug Administration (FDA) has issued a black box warning against Sertraline about the increased risk of suicidal thoughts and behaviours in adolescents.
Close monitoring and careful balance between the potential benefits over risks should be maintained particularly in young patients taking Sertraline in their early course of treatment to avoid suicidal effects.
Why does Sertraline have a black box warning?
Sertraline and other SSRI antidepressants are issued a black box warning by the USFDA for their suicidal effects on adolescents and young children.
Sertraline is a drug of choice for major depressive disorder (MDD), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and other mental health conditions.
Serotonin plays an important role in mood uplifting. While on sertraline, there is a surge of serotonin in the brain which may cause serotonin imbalance usually in young patients that leads to suicidal thoughts and behaviour.
Sertraline may develop suicidal thoughts among the younger population (up to 25 years) during the initial course of treatment. These thoughts are generated especially while starting, changing, or discontinuing the medication (1).
Sertraline is given a black box warning to emphasize the importance of careful monitoring of the dosage given to patients. The early treatment period may induce mood or behaviour changes in patients taking Sertraline (1).
Which factors can influence the black box warning of Sertraline?
There are various factors that can influence the black box warning of Sertraline. Some of them include:
- Age
- Dose variation
- Individual variability
- Frequent dosage adjustments
- No regular monitoring
- Serotonin imbalance
Many antidepressants fall under the category of boxed drugs due to such factors. Careful monitoring of signs and symptoms after taking boxed drugs is essential to avoid any hazardous event from happening.
However, side effects may vary individually but seeking medical help is necessary upon the emergence of adverse effects.
How to ensure the safe use of Sertraline?
To ensure the safe and effective use of Sertraline always follow the recommended schedule given by your prescriber. Sertraline may take 4-6 weeks to show its effects therefore, do not abruptly discontinue the drug if you don’t see the results immediately.
Carefully monitor your signs and symptoms of suicidal thoughts and behaviours at the beginning of treatment and at times of dosage changes. It is especially advised for young adults and children (3).
Always take Sertraline in the prescribed dosage only. It is important to counsel family members and the caregivers of the patients to look for emergent behavioural changes and immediately alert their doctor (3).
If the condition of the patient is persistently getting worse, then changing the therapeutic regimen or discontinuing Sertraline may also result in better outcomes. But this should only be done under your doctor’s supervision and guidance (3)
What other drugs come with black box warnings?
Some other drugs with black box warnings from the FDA include (4):
- Fluoroquinolone antibiotics (Tendinitis or tendon rupture risk)
- Rosiglitazone (Myocardial infarction risk)
- Celecoxib (Cardiovascular or gastrointestinal risk)
- Medroxyprogesterone (Long-term use induces decreased bone density)
Patients should be informed about the boxed warning drugs before prescribing them. They should be well aware of the possible harmful effects that the boxed medications have the potential to cause.
They should be warned about regular and careful monitoring of their symptoms and side effects after taking boxed medications.
Conclusion
In this article, we have discussed the black box warning associated with Sertraline. We have also discovered some other drugs with black box warnings given by the FDA. We have looked at the ways to ensure safe and effective use of Sertraline.
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References
1.-
Fornaro M, Anastasia A, Valchera A, Carano A, Orsolini L, Vellante F, Rapini G, Olivieri L, Di Natale S, Perna G, Martinotti G, Di Giannantonio M, De Berardis D. The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? Front Psychiatry. 2019 May 3;10:294. doi: 10.3389/fpsyt.2019.00294. PMID: 31130881; PMCID: PMC6510161.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6510161/
2.-
ZOLOFT (sertraline hydrochloride) tablets, for oral use. ZOLOFT (sertraline hydrochloride) oral solution. Initial U.S. Approval: 1991. Reference ID: 4032692. Revised:12/2016https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s74s86s87_20990s35s44s45lbl.pdf
3.-
Delong C, Preuss CV. Box Warning. [Updated 2023 Jun 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538521/
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