Does trazodone have a black box warning? (+3 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 discuss whether trazodone has a black box warning or not. We will look into the common factors that make a drug listed as a black-boxed medication. We will also discover the potential risks attached to trazodone.
Does trazodone have a black box warning?
No, trazodone does not have a black box warning. The US Food and Drug Administration (FDA) has not declared trazodone to have any black box warning regarding its use.
Trazodone belongs to the serotonin antagonist and reuptake inhibitor drug class of antidepressants. Trazodone is used in the management and treatment of major depressive disorder. Trazodone is also used off-label for the treatment of insomnia, Alzheimer’s disease, bulimia, fibromyalgia, and substance abuse (1).
Black box warnings are the highest safety-related warnings for a medication assigned by the FDA. These warnings are given to a medication to ensure its safe use by the consumers and to aware them of the major risks associated with a certain medication (2).
Several medications have been assigned the black box warning by the FDA which does not mean stopping the medication use but rather just being aware of the potentially severe effects of that drug. However, trazodone is not a black-boxed medication.
What are the potential adverse effects of trazodone?
Some potential side effects of trazodone are (1,2):
- Nausea
- Vomiting
- Diarrhoea
- Constipation
- Changes in appetite
- Weakness
- Tiredness
- Dizziness
- Nightmares
- Muscle pain
- Dry mouth
- Sexual problems in men and women
Severe adverse effects related to trazodone include (1,2):
- Loss of consciousness (coma)
- QT prolongation
- Seizures
- Shortness of breath
- Arrthymia
- Priapism
- Increased suicidal thoughts
However, it is important to note that not all patients taking trazodone will experience the above-mentioned side effects. If you are facing severe side effects due to trazodone, then consult your healthcare provider.
Trazodone is generally a safe medication that does not mess you up. These adverse effects have also not been reported with severity to the extent that it requires a black box warning.
Why is a black box warning assigned to a medication?
Black box warnings are assigned to certain medications due to their potential hazardous adverse effects. A black box warning is assigned to medications by the US Food and Drug Administration (USFDA) based on certain factors and criteria (2).
Having a black box warning label does not make a drug completely contraindicated to use. Rather, it is a warning to use a particular drug with caution to avoid potential adversities (2).
Clinicians are supposed to prescribe such drugs based on their clinical knowledge and expertise. Clinicians are also supposed to educate the patients and warn them about the potential adverse effects to avoid any potentially harmful outcome (2).
What factors influence the black box warning?
Assigning a black box warning to medication depends on various factors. Some of them include:
- Age range
- Severity of adverse reactions
- Prolonged use risk
- Risk-benefit ratio
- Lack of alternative treatments
- Safety concerns
A medication goes under thorough evaluation and clinical trials before it is assigned with a black box warning by the FDA. Therefore, doctors must make well-informed decisions while prescribing boxed medications to patients.
What are some medications with a black-box warning?
Some medications with a black box warning are (2):
- Fluoroquinolones- Due to the increased risk of tendinitis/tendon rupture.
- Selective serotonin reuptake inhibitors- Increased risk of suicidal thoughts and behaviors in pediatric patients such as sertraline.
- Rosiglitazone- An increased risk of heart failure or myocardial infarction in cardiac patients.
- Celecoxib- Due to increased cardivascular and gastrointestinal risks.
- Medroxyprogesterone- Long-term use may decrease bone density.
However, it is important to note that having a black box label on medication does not make it contraindicated to use rather it needs special monitoring and attention to avoid potential adverse effects.
How to ensure safe use of trazodone?
To ensure the safe use of trazodone, always consult your healthcare provider before taking it. Make sure you follow the prescription given by your doctor regarding trazodone.
To ensure the safety of trazodone, make sure to take properly stored and effective medication that has not crossed the expiration date.
To ensure the safe and effective use of trazodone, make sure to take it at the right time prescribed by your doctor. Usually, trazodone is taken at night time because the morning dose of trazodone may cause daytime drowsiness and can affect your daily activities.
In conclusion, I would suggest that always take trazodone as prescribed by your doctor. If you face severe side effects, then consult with your doctor for a dose reduction or regimen change based on your health condition.
In the end, I would add that trazodone does not have a black box warning, but it has the potential to cause some severe adverse effects as mentioned. Therefore, careful monitoring is required if you face such adverse effects.
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References
1.-
Shin JJ, Saadabadi A. Trazodone. [Updated 2022 Jul 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470560/
2.-
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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