Microsoft word - sample_ medical.doc

Does the Use of Accutane Cause Depression and Suicide in Teenagers? This research paper is aimed to discuss the use of accutane in the context of triggering depression and suicidal tendencies among teenagers. Two contradicting statements on this topic from established medical journals will be scrutinized in terms of authenticity, evidence, assumptions, missing links and any ambiguity in reasoning. Does the Use of Accutane Cause Depression and Suicide in Teenagers? Hoffman-La Roche were authorized to market accutane in 1982 to treat severe nodular acne. This drug also made claims that it was beneficial for the "psychological trauma" and "emotional suffering" endured by teenagers that is linked with acne .On February 25, 1998 the Federal Drug Administration (FDA) came out with a notification about the occurrences of depression, suicide, and psychosis in patients using accutane. Subsequently, the manufactures of this drug, has since updated the drug label and ceased to advertise about the psychological benefits of the drug. Although the exact figures for suicides associated with accutane are not available due to reporting discrepancies, the combination of teens and the use of accutane The first statement that will be deliberated negates the theory that the use of accutane causes depression and suicidal inclinations among teenagers. This statement has been sourced from the article titled “Clinical consult- Accutane and Depression” (Brutoco). The author informs that treating teenagers for acne related problems with acutane if prescribed correctly would not lead to depression and suicide. The reason that Rudolf attributes to his claim is that the after effects of using accutane are more pronounced when the dosage levels exceed 40- 100 mgl/day. The veracity of this observation will now be explored in logical manner. The author’s information on the deleterious effects of using accutane on teenagers is based on a clinical approach and his remarks are corroborated with personal experience of suggesting this drug for severe acne treatment. He has explained at length the potential risks of prescribing accutane without masking any of its side effects. Apparently, accutane induced depression is a very slow process and it make take 4-8 weeks to visualize this effect. Also, the teenagers are not barely aware of this phenomenon nor there are any symptoms to alert neither the patient nor the doctor. In this context the author argues that physicians tend to prescribe this drug to teenagers beyond the dosage mentioned earlier, which makes it difficult to monitor any signs of depression on a sustained period owing to their professional preoccupations. This has deterred primary care physicians from prescribing this drug. On the other hand the dermatologist find this as a useful drug for treating acne related problems among teenagers but they are found wanting in terms of detecting these side effects and suggest remedies. Another valid point that the author mentions is that many of the teenagers are already treated for affective disorders and hence they are susceptible to this drug. He extends his theory to his profession by prescribing this drug to teenagers in a very systematic way. Typical dosage starts from 10 mgl/day to 20 mgl/day as the treatment progresses and simultaneously he monitors the teenagers from an emotional angle. He infers that with this type of approach the acne problem will take some more time to heal (8-10 weeks) to attain full facial clearing but there were no instance of any depression/suicide tendencies among the teenagers treated with this drug .He adds that there is also a possibility of acne relapse even when high doses of accutane is used and thereby increasing the risk of depression. A key factor the author brings to focus is that these side effects can be neutralized if accutane is consumed along with food on a b.i.d basis. The most convincing assurance proposed by the author is that despite the adverse fallouts of using accutane he finds this drug very challenging and rewarding. He finds this drug when used with caution can produce remarkable results in teenagers treated for acne, which can dent ones self esteem, and confidence. The concluding remarks that he is very comfortable suggesting this drug to teenagers and in tandem monitor the behavioral aspects, which will prevent depression and suicide is a manifestation of his arguments on the positive side of accutane. The second statement which is contradictory to the one discussed above is taken from the New England Journal of Medicine and the report is titled as “Depression and Suicide in Patients Treated with Isotretinoin” (Wysowski, Diane k., Pitts, Marilyn and Beitz, Julie, 2001). The main contention of this article is that the treatment of accutane had lead to severe side effects resulting in depression and suicide. The authors provide the following records to substantiate their claims. Between 1982 and May 2000, the FDA received information on 431 cases of depression, suicidal ideation, suicide attempts, or suicide in U.S. patients treated with accutane (isotretinoin). Among these patients, 31 (84 percent) were male, and their median age was 17 years (varying between 13 to 32). During the same period, the FDA examined reports of 110 U.S. patients who were hospitalized for depression, suicidal ideation, or suicide attempts while using isotretinoin (85patients) or after stopping its use (25 patients). The outcome was that out of the total 110 patients, 62 (56 percent) were female and their median age was 17years (range, 12 to 47). Valid evidence that supports the above statistics is that in the US, isotretinoin ranks among the top 10 drugs in the FDA’s database in terms of the number of reports of depression and suicide attempts among its users. The point that adds strength to the negative aspect of accutane is that the possible explanations for the high number of such reports are better reporting than with other drugs and a relation between severe acne and depression associated with teenagers. The most authentic proof is in the form of FDA’s intervention in 1998 to compel the manufactures of accutane to come up with a label warning the patients about the side effects of this drug. There were instances in which some patients who reported depression also complained that the depression subsided when they stopped taking the drug and came back when they resumed the treatment. Accutane is one of just three drugs in the United States that has ever been warranted to come with a Medguide .A more recent development that will supplement the labeling procedure has come from FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee which has advised that more information be made available concerning these adverse events. To counter the adverse fallout of accutane on teenagers it is now the onus of physicians to request that patients and their parents report promptly any changes in behavior that might be symptomatic of depression. This will pave way for a better behavioral examination and be evaluated for To summarize the debate on the two contradictory statements the following points will have to be examined in total before arriving at a logical conclusion. Firstly, there is no concrete proof to substantiate any kind of biological plausibility for how the drug might even cause depression. The active ingredient in Accutane (isotretinoin) is a Vitamin A derivative and overdoses of Vitamin A can be toxic. But there is no evidence that hypervitaminosis A can cause psychiatric reactions. Secondly, teenagers to treat acne are predominantly using this drug and hence they are fallible to emotional unrest owing to reduction in self-esteem, which can lead to depression and in the long run suicide. Hence, this drug should be administered to teenagers after informing them of the negative implications and their behavioral pattern should be constantly monitored to record any serious alterations. Lastly, accutane should be only used for treating acute acne problems in teenagers and should be very much limited to this skin disorder. Accutane (isotretinoin) and psychiatric adverse effects. Practice Health And Drug Alerts. Canadian Medical Association (Jan 2003). Brutoco, Rudolf L.Clinical Consult: Accutane and Depression. Life stages Center for Developmental Medicine. 1 Dec 2003. <http://www.manisses.com>. Lamberg, Lynne. (1998). Medical News & Perspectives: Acne Drug Depression Warnings 25 Nov 2003. <http://jama.ama-assn.org>. Schwetz, Bernard A. (2001). From the Food and Drug Administration: New Measures to Manage 25 Nov 2003. <http://jama.ama-assn.org>. Vastag, Brian. (2002). Health Agencies Update: More Stringent Rules on Accutane. 25 Nov 2003. <http://jama.ama-assn.org>. Wysowski, Diane k., Pitts, Marilyn and Beitz, Julie. (Feb 2001). Depression and Suicide in 1 Dec 2003. <http://content.nejm.org>.

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Microsoft word - earlydrain study protocol 2.1 (final).doc

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