Category Archives: Risk Management

No Rest for the Weary

New warnings were issued by the FDA for prescription sleep aids yesterday.   The media coverage of the issue focused on the claim by some users of these drugs that they experienced "sleep-driving" – getting dressed and getting in a car … Continue reading

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Ketek Gets New Label

The FDA announced the issuance of a new label for Ketek (telithromycin) that strips away two indications for use of the drug – acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis – and retaining the sole remaining indication, … Continue reading

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Testing Risk Management

Last night, ABC News carried a report that teen suicide has increased since the Black Box Warning was labeled for anti-depressants.  It is very unpleasant news.  The ABC News Report states that: "According to the Center for Disease Control and … Continue reading

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The New FDA Drug Safety Initiative – Policy and Communications Implications

Yesterday the FDA announced yet another new initiative on drug safety.  This is apparently in addition to the pre-existing Drug Safety Initiative.  It is an action taken in response to the Institute of Medicine (IOM) report – The Future of … Continue reading

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Anti-depressants and Labels

Yesterday, the FDA held an advisory committee meeting on the labeling of anti-depressants in adults.  I was not present, but heard coverage of the meetings on National Public Radio.  There was wrenching testimony by those who have lost loved ones … Continue reading

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