Talk:FDA officials question safety of antibiotic 'Ketek'

Latest comment: 18 years ago by Doldrums in topic Publish

This article should not be abandoned. I added the source as requested from the New York Times. Look, FDA infighting regarding safety is a very significant public health and political issue hearkening back to the Vioxx and Crestor issues in the recent past, thus the impetus for this story. It's newsworthy, timely, of keen short and long term public interest. With the Times scooping these controversial documents (E-mails) from an unnamed source, there's clearly public import. Congressional interventions are also underway. Ketek (telithromycin) is the newest antibiotic in its own class (ketalide) and heavily prescribed in the US for children and adults largely for respiratory illness. It'd be a shame if this article doesn't see the light of day because I didn't properly reference it the first time.--Piewalker 01:14, 21 July 2006 (UTC)Reply

NPR Morning Edition source found and added as a confirmation of The Times article. The audio news report offers additional context to the safety debate that may be relavent to this article. By the way, Dr. Graham is the same officer who submitted a data-intensive safety report on Vioxx(http://www.fda.gov/CDER/DRUG/infopage/vioxx/vioxxgraham.pdf).--Piewalker 03:53, 21 July 2006 (UTC)Reply

the FDA has info regarding this at [1]. Doldrums 05:55, 21 July 2006 (UTC)Reply

m. gravis

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why was myasthenia gravis reported as a "mortal" consequence? Doldrums 08:14, 21 July 2006 (UTC)Reply

...Because it can potentially cause death. The FDA requested Sanofi-Aventis to update the U.S. prescribing information, including more detailed information of myasthenia gravis. I have not seen incidence/prevalence data on this. The drugmaker released the new PI June 29, as cited in the article.--Piewalker 21:24, 21 July 2006 (UTC)Reply


Publish

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How do I edit the headline? I can't see it here in the editing area. I need to make use lower caps. Can anyone advise?--Piewalker 04:24, 23 July 2006 (UTC)Reply

Thanks for the last minute clarifications, Doldrums. The article looks fair and balanced. Your additions, paragraphing, and rearrangements were also very good. Thanks much for the help. --Piewalker 05:34, 23 July 2006 (UTC)Reply

no thanks necessary. look forward to working with u on wikinews. (and i'll take the "fair and balanced" in its literal sense :) ) Doldrums 05:53, 23 July 2006 (UTC)Reply
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