8 Apr 2022

124

Black Box Warnings Controversy

Format: APA

Academic level: College

Paper type: Essay (Any Type)

Words: 1655

Pages: 5

Downloads: 0

Introduction

Use of antidepressants incorporated with psychotherapies has been the most common way of treatment for depression practiced by most clinicians handling depressed patients who include adults, youths, and children. Being a serious mood disorder, depression results in the severe effects that impact the way individual think does things and responds to the environment around them. As a result, intense depression may lead to harm of others and or self and individuals may contemplate committing suicide. Like many other medications prescribed to patients, antidepressants have presented certain side effects to its users that include nausea, headaches, fatigue, change in appetite and weight among others. According to the Food and Drug Administration (2004), additional side effect of antidepressants includes the increase in the risk of its users being exposed to behaviors, thoughts, and feelings of committing suicide. In response to this claim, they issued a ‘black box warning’ that led to the creation of description insertions that were placed in the medicine as a reminder to the consumers (FDA Consumer Health Information, 2016). 

The ban on the use of antidepressants contradicts the notion that antidepressant calms the patient and is a vital form of treatment to patients whose depression is not intense. On the other hand, depressed children of all ages were placed on a psychosocial process as an intervention to seek treatment; unless this did not work then they would be assigned to the use Fluoxetine which is the only antidepressant that was acceptable to children above the age of eight. The use of Fluoxetine as an antidepressant in children and not any other form of antidepressant creates the disparity in the findings of whether the claims that antidepressants really increases the chances of its users to have behaviors, feelings and thoughts of suicide. The controversy is majorly on the fact that, intense depression may lead to the patients committing suicide yet, on the other hand, the FDA claim that the use of antidepressants which are the most commonly medical treatment for depression, may subject its users on suicidality behaviors, but yet still Fluoxetine is used on children above the age of eight.

It’s time to jumpstart your paper!

Delegate your assignment to our experts and they will do the rest.

Get custom essay

Controversy Summary

Food and Drug Authorities have the mandate to ensure that the drugs supplied to consumers are in a position to be of benefit and have minimal side effects or risks that come with its use while treating a given condition. The black box warning was majorly issued in order to curb the rate of suicides that were associated with the use of antidepressants. The most preferred and most prescribed antidepressant includes Selective Serotonin Reuptake Inhibitors - SSRIs, Serotonin and Noradrenaline Reuptake Inhibitors – SNRIs, and Noradrenaline Reuptake Inhibitor. Ironically, the ban of the mentioned antidepressants contradicts with the fact that Fluoxetine is still used in children who are above the age of eight yet it is one of the major ingredients in SSRIs. The warning was viewed by physicians who were against the FDA claims and issue, that it would only hinder patients who would benefit from the treatments to access or make use of the prescribed antidepressants causing them more harm than good. In regard to the findings of the research on the effects of the FDA black box warning between the years 2000 to 2011, the use of antidepressants significantly changed for adults, youth and children. On the contrary, from 2008, the use of antidepressants slowly began to rise again in the youths. Although the FDA advisory on the use of antidepressants was targeted to children and youths alone, the effects were also seen in the change of the use in adults too, who were not initially included in the warning bracket. Furthermore, besides the reduction of the prescription of antidepressants by the physicians, the research conducted found out that the number of depression diagnosis too went down (Friedman, 2014). 

According to Jacqueline Sparks (2016), the increase in the use of antidepressants in the youth could have been as a result of the increase in suicide cases among the youth after the issuance of the black box warning, hence resorting to the continual use of antidepressants on patients. Moreover, the rate of the suicide cases was higher as compared to the suicide cases that existed before the issuance of the black box advisory by the (FDA Consumer Health Information, 2016).

The issuance of the black box warning on the use of antidepressants in patients with depression has had a positive impact on parents and other family members of the parents in that they are encouraged to take time and read the description inserted in the medicine hence improving on the right way of medical use. Furthermore, the family gets more involved in the use of psychotherapy as a form of treatment and placebos which have been identified to be effective too. Physicians and clinicians have the duty to protect the lives of their patients hence whether or not the ban of antidepressants is valid, they are obligated to take note of it and find better ways to handle patients with depression as they research more on improving the antidepressants or coming up with medication that does not pose severe risks to the patients. 

Friedman and Leon (2007) notes that, with or without any medication on depressed individuals, the illness itself puts the patient at risk of committing suicide since it is a psychiatric condition whose severe effects includes the thoughts and feelings of suicidality. In other words, the use of antidepressants may not be necessarily the cause of these feelings or behaviors. As for home caregivers and medical caregivers in mental healthcare, there should be an understanding of the effects of the drugs administered to the patients. For instance, many of the patients are observed to be very proactive after the use of the antidepressants within the first few weeks and therefore since the thoughts and feelings of suicide are major signs and symptoms of depression it is really hard to determine that the medication was the reason for the development of the signs of suicide or was it because of the illness within the individual.

In regard to the disparities in the findings, it is important for home and medical caregiver to handle the cases of depression with so much caution since the illness itself is a risk to the lives of the patients. On the other hand, the reaction of the use of antidepressants may increase the chances of suicidality since in ignites the underlying illness. Having the right information, the home caregivers should collaborate with the health caregivers to make the right choices in treating and managing the condition as it is a necessity. Understanding the degree of the condition and the required form of treatment may engage the family in assisting the patient to get better much faster as compared to letting the healthcare givers handles everything by themselves (Regan et al., 2016).

Depression is a psychiatric condition and in many instances, its core treatment may just be based on psychotherapies that help the individual and assures them that they can behave in a certain manner other than the way they are. The power of the mind dictates an individual’s character and choice of thoughts. Similarly, depression may be carefully handled by use of placebos and psychotherapies which in most cases have had effective results to the patients.

Antidepressants like any other form of medication may result in an up rise of the symptoms of the condition being treated within the first few weeks. Therefore the suicidal behaviors observed after administering antidepressants to a patient in many cases are not as a result of the antidepressant but the hidden condition of the illness (Friedman and Leon, 2007).

Suicide, is a case that is contrary to the number one requirement of healthcare givers to save lives, hence the continual seizing in use of antidepressants may inquire more danger to patients than good which may explain the increase of suicide cases in youth years after the ban and use of antidepressants. Psychologically, the warning inscribed in the description papers of the antidepressants may interfere with the positive thoughts in an individual and may cause radical reactions to it including pessimism in the condition which will hinder the effectiveness of any other form of treatment (Sparks, 2016).

Recommendations

The positive effective of the black box warning has been the caution healthcare givers take in prescribing medication to their patients. In addition, the increase in intensive research that has been vital in finding solutions for the depression condition has been observed and contributed to vital results. Therefore, it is important for medical practitioners to work hand in hand with their patients and family members in order to come to a consensus on what is best while treating the patients. This also improves the relationship and the chances of making right choices as everyone is involved (Sparks, 2016).

The medical field should maintain the use of antidepressants on the depressed patients because unlike psychotherapies, they calm and at the same time trigger the nerves, which explains the hyper reactions observed in patients. In most cases, the physicians should be in a position to determine what is best for the patients. Placebos and psychotherapies should be emphasized since depression is a mental condition whose treatment should be psychological (Friedman and Leon, 2007).

The FDA has a right to regulate the safety of drugs in the shelves and the ones supposed to be prescribed in the health care centers to ensure the safety of patients. Therefore, they should also be in a position to give enough information and proof on the warnings they pose in certain medications.

Conclusion

The black box controversy reveals the lack of sufficient information on the reasons for the ban of antidepressants as a form of medication for depression. Furthermore, it also shows the ignorance that medical practitioners have to the effects of medications in their patients. Antidepressants have proved to be effective in treating and managing depression. The fact that the illness itself poses danger to the lives of the patients, the antidepressants should not be reasons enough to hinder the patients from benefiting in acquiring proper medication. Therefore, it is vital to make use antidepressants as a pathological way of medication. Incorporation of psychotherapy and placebos is also advised since antidepressants are not a panacea. The collaborations of family members, the medics, and the patients improve the care given to the patients as decisions are critically analyzed.

References

FDA Consumer Health Information. (2016). A Guide to drug safety terms at FDA 1st ed. [ebook] Consumer Health Information Available at: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM107976.pdf [Accessed 7 Nov. 2016].

Friedman, R. (2014). Antidepressants' Black-Box Warning 10 Years Later:  New England Journal of Medicine , 371(18), pp.1666-1668.

Friedman, R. Leon, A. (2007). Expanding the Black Box — Depression, Antidepressants, and the Risk of Suicide  New England Journal of Medicine , 356(23), pp.2343-2346.

Regan, J., DeWire, M., Whitby, B., Bess, T. and Wright, A. (2016). The “Black Box” Controversy  Mental Health Series Available at: http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.579.5309&rep=rep1&type=pdf.

Sparks, J. (2016). Outside the Black Box: Re-assessing Pediatric Antidepressant Prescription.  Journal of the Canadian Academy Child and Adolescent Psychiatry 22(3) Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3749900/#b14-ccap22_3p240

Illustration
Cite this page

Select style:

Reference

StudyBounty. (2023, September 14). Black Box Warnings Controversy.
https://studybounty.com/black-box-warnings-controversy-essay

illustration

Related essays

We post free essay examples for college on a regular basis. Stay in the know!

17 Sep 2023
Education

Personal Statement for College

Growing up in the inner city especially as a first-generation African-American is very challenging mainly because of poverty that makes every aspect of life difficult. These are neighborhoods with poor services and...

Words: 926

Pages: 3

Views: 115

17 Sep 2023
Education

Phonics and Phonemic Awareness Lesson Plan for Kindergarten

The objective of this lesson plan is to teach students how to add or interchange individual sounds within one syllable words. The will the students to learn new words and new pronunciations. The use of CVC word...

Words: 329

Pages: 1

Views: 222

17 Sep 2023
Education

Similarities and Differences of Educational Theories

As a philosophy of education, idealism is based on the notion that reality should only be inferred from ideas. People should strive to conceive ideas as the only source of world reality. They must apply conscious...

Words: 1304

Pages: 5

Views: 89

17 Sep 2023
Education

How to Overcome Financial Challenges in Research

Running a school and improving the way it operates requires the availability of resources, prime of which is money. The financing of school budgets in the US varies between school districts and states. The...

Words: 3007

Pages: 10

Views: 57

17 Sep 2023
Education

Suggestopedia Learning Method Analysis

The video is an explanation of the suggestopedia, and this is a learning method that’s used in classrooms, particularly in those ones in which students are taking English as their second language. This method is...

Words: 926

Pages: 3

Views: 61

17 Sep 2023
Education

Behaviorist versus Humanist Philosophical Orientation

Purpose of the philosophical orientation Psychologists and other researchers have for the longest time tried to unearth the behavioral orientations of individuals by integrating numerous approaches. One of the most...

Words: 2558

Pages: 9

Views: 134

illustration

Running out of time?

Entrust your assignment to proficient writers and receive TOP-quality paper before the deadline is over.

Illustration