Question

Previous research has shown that reporting bias has inflated the apparent efficacy of antidepressants. We investigated whether apparent safety was also affected. We included 133 trials, involving 31,296 patients, of second-generation antidepressants for the treatment of major depressive disorder (MDD) or anxiety disorders, obtained from Food and Drug Administration (FDA) reviews. We extracted data on overall discontinuation, discontinuation due to adverse events, and serious adverse events (SAEs). Meta-analysis was used to compare discontinuation rates between FDA reviews and matching journal articles, while SAEs were compared qualitatively. The odds ratio for overall discontinuation, comparing drug to placebo, was 1.0 for both sources, while that for discontinuation due to adverse events was 2.4 for both sources. Seventy-seven of 97 (79%) journal articles provided incomplete information on SAEs; sixty-one (63%) articles made no mention of SAEs at all. Of 21 articles which could be compared to the FDA, only 6 (29%) had full reporting without discrepancies. Nine (43%) articles reported a discrepant number of SAEs. Descriptions were absent or discrepant in 6 (29%) additional articles, even for important SAEs such as suicide attempts. In conclusion, reporting bias has not affected average discontinuation rates over trials. However, SAE reporting is not only very poor, with over half of articles failing to discuss SAEs altogether, but discrepancies between the FDA and articles were common and often led to a more favorable drug-placebo comparison. These findings suggest that journal articles are an unreliable source of data on SAEs in antidepressant trials.

How the FDA review and the published results, as discussed in this article are problematic.

150 words no plagiarism Thanks

Answer 1

The Food and Drug Administration (FDA) mentioned quantitative research methods to state the Anti-depressant drugs. It reviewed about the efficiency, discontinuation and severe drug reactions. The analysis is problematic, because of Anti- depressants continuous intake even causes loss of efficiency of drug activity and discontinuation of drug due to adverse effects has been mentioned usually the serious adverse effects like suicidal thoughts are seen after the discontinuation of drugs. The Anti- depressant drug use if started it becomes addiction. It may be effective therapy for some major depressive disorders but though there are chances of relapse of depression and anxiety among them. The placebo drugs only work for the indviduals who is resiatant to anti- depressant drugs. The FDA provided research information in the pattern of promotion of Anti- depressants drugs without the justification for the safety of consumers, due to information bias as there is a chance of start and increase in intake of anti- depressant drugs and intake suffers as its addiction activity, discontinuation effects and relapse of depression along with psychological changes worsen individuals well- being who choose and are being on Anti- depressant drugs.