Safety of SSRI Drug Fluoxetine

Summarizing a Research Article
Research Question
The research question for the article by Rossi, Barraco and Donda (2004) was based on the fact that there had been no review of the meta-analyses published on Fluoxetine. Fluoxetine is an important drug that was developed for and prescribed to patients with depression starting in the late 1980s. It is considered the first iteration of the generation of Selective Serotonin Re-uptake Inhibitors (SSRIs) commonly associated with youths suffering from mental health problems. However, though it has been widely studied, fluoxetine is still not completely understood. Thus, the authors of this study set out to answer the question: What do the available meta-analyses on this SSRI actually say? The objective of the systematic review of the literature was threefold:
1. to evaluate the strength of the information available in reviewed meta-analyses
2. to understand if the use of fluoxetine is clinically effective and safe compared with previously available drugs
3. to point out the drug's current role in the treatment of diseases where fluoxetine is indicated (Rossi et al., 2004, p. 2).
In short, the authors intended to evaluate whether previous information published on the drug is accurate and reliable; to see if the compile information shows that the drug is safe relative to drugs that had hit the market before; and to see what the use the drug offers in treatments today.
Hypothesis Tested
The authors did not clearly identify a hypothesis that they were testing. However, they did state that upon reviewing the literature on fluoxetine’s effect on treating depression that all the studies confirmed the hypothesis that the drug is more effective at treating depression when given at the lower common dosage of 20 mg/die than at higher dosages (Rossi et al., 2004). Oddly, however, there is no other mention of this hypothesis that is referred to. The authors engage in no hypothesizing of their own—neither in the introduction nor in the discussion of the study’s objectives. The reference to hypothesis confirmation in the description of the findings is random in the sense that it is the first explicit mention of a hypothesis. It seemingly refers to the hypothesis of the researchers whose study is described by Rossi et al. (2004) in the literature and not to any hypothesis developed by Rossi et al. (2004).
Methods
Design
This was a qualitative meta-analysis of literature published on fluoxetine. The databases searched were Medline, Embase and Cochrane. Only meta-analyses were searched in these databases. Specifically, meta-analyses, in which fluoxetine was directly compared to a placebo or to other drugs, were used by the researchers.
Participants
There were no participants in this study. It was a qualitative meta-analysis—i.e., a literature review. The study was exploratory.
Materials
Materials used were the databases and the documents obtained from the searches conducted.
Procedure
The researchers searched the three databases using the keywords fluoxetine and meta-analysis and various combinations of those words. Documents that were not meta-analyses were discarded. Meta-analysis that did not compare the drug to either a placebo or other drugs were discarded. 25 articles remained. The researchers then assessed the methodologies of the articles closely and discarded 16 more, deciding that they did not meet the criteria of the authors, either because the analysis was a duplicate of another study already included or because the drug was not compared to others or because the methodology was deemed faulty.
The researchers then summarized the 9 remaining articles in order to address the 3 research objectives regarding strength, safety and current role of the drug. Findings were discussed under the following headings, referring to ways in which the drug was tested for treatment: Depression, Bulimia, OCD, Suicide, Elderly Depression, and Pregnancy.
There were no independent variables or dependent variables assessed in this qualitative literature review.
Results
The results of the meta-analysis indicated that the fluoxetine was safe, best when used at a 20 mg/die dosage, and that its side effects were negligible. The literature reviewed was deemed to be strong but that when compared to placebos the studies were not as effective as they should have been. The researchers discussed the limitations of these placebo comparison studies and offered a recommendation on how to improve them—namely, by compensating for the number of participants who dropped out of the study early after placebo usage.
There were no significant differences among the studies analyzed. The researchers found that the most common side effect was dry mouth. Other side effects of the drug disappeared after two weeks. The authors used this information to conclude that fluoxetine was better than other drugs on the market.
Key Implications
Based on the findings of the meta-analysis, the authors imply that fluoxetine is effective at treating depression and is safer than other drugs when it comes to the issue of overdosage. However, the researchers found that the most effective dosage, based on the literature, was the lower one at 20 mg/die. This means that in order to provide the best pharmacological intervention for depressed patients, the dosage should be capped there except for cases in which more is justified.
Conclusion
The study by Rossi et al. (2004) was a qualitative meta-analysis literature review of prior meta-analyses conducted on the drug fluoxetine when comparing its usefulness to a placebo or to other drugs. The analysis found that fluoxetine is safer than other drugs, that its role in today’s health care landscape should still be prominent, and that the studies conducted on the drug were strong.
References
Rossi, A., Barraco, A., & Donda, P. (2004). Fluoxetine: a review on evidence based medicine. Annals of General Hospital Psychiatry, 3(1), 2.