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Drug Warnings That Can Cause Fits — Communicating Risks in a Data-Poor Environment
Oleh:
Avorn, Jerry
Jenis:
Article from Journal - ilmiah internasional
Dalam koleksi:
The New England Journal of Medicine (keterangan: ada di Proquest) vol. 359 no. 10 (Sep. 2008)
,
page 991.
Fulltext:
(991)359no.10.pdf
(111.19KB)
Ketersediaan
Perpustakaan FK
Nomor Panggil:
N08.K.2008.05
Non-tandon:
1 (dapat dipinjam: 0)
Tandon:
tidak ada
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Isi artikel
In 2005, after receiving case reports of suicides by patients taking anticonvulsant medications, the Food and Drug Administration (FDA) asked the manufacturers of 11 drugs in this class to report all suicide-related events in the controlled trials they had conducted over many years. This past January, nearly 3 years later, the agency completed its analysis of these data and announced that it had found a near-doubling of suicidal ideation and behavior among trial subjects randomly assigned to receive these drugs rather than placebo1 (odds ratio, 1.8; 95% confidence interval [CI], 1.2 to 2.72). For patients in epilepsy studies, the . . .
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