Re: Drug Safety [1 Attachment]

[Guest guest]

Dear Tarun,I must confess that I am a little lost as to the purpose of this series of posts, hoping to look for the purpose of the presentation in the first few posts. Nevertheless, I was looking at the document on the black box warning on SSRIs that the FDA issued and was looking at the level of evidence by way of existing meta analyses and systematic reviews on the association between SSRI and suicidal ideation among children. Among the first few articles that the search results came up with, one article was an ecological study on the effects of this advisory. Overall, based on secondary data analyses from records from two countries with different health care system (the Netherlands and the US), the analyses showed that following the restrictive advisory, the prescription rate went down but the suicide rates nevertheless went up anyway. Here is the link to the abstract for your review:http://goo.gl/DoZFHFor a more detailed and meaningful discussion, I urge you and others to read the article in full text (I found it freely available, if that is not the case with you, please let me know). The reason this article caught my attention was the fact, that black box advisories may not always be based on sound evidence generation, nor can they necessarily lead to better public health outcomes. These need to be tempered with appropriate actions aimed at addressing the larger goal: in this instance it would be wise to educate the physicians and addressing other concerns of teenage suicidal ideations. The counterfactuals and the opportunity costs of safety and those considerations are often quite complex and one needs to address many other variables. Thank you for posting an interesting study. Would be good to hear from you and others what they think about these issues.Best wishes,Arin Sent from my iPadOn 10/10/2011, at 12:53 AM, tarun wadhwa <pharma_tarun@...> wrote:

Dear Members,

FDA urges “black box†warning on pediatric antidepressants

(read the attached article).

Tarun Wadhwa