Category Archives: FDA

Dabigatran and injury – report your concerns

Posted on November 25, 2011 by admin

Concerns about a lack of specific antidotes for new anticoagulants has existed for some time, despite the benefits they may bring in other aspects of care. An important piece of correspondence in the New England Journal of Medicine notes the … Continue reading →

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Varenicline and suicidal behaviour

Posted on November 10, 2011 by admin

A recent study of suicidal behavior and depression in smoking cessation treatments has been published at PLoS ONE. This was widely reported in the media. The authors made the following statement within the paper: In conclusion, varenicline shows a substantial, … Continue reading →

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Bevacizumab (Avastin) and breast cancer

Posted on December 17, 2010 by admin

After reviewing all available data relating to the use of Avastin to treat metastatic breast cancer, the FDA has decided the risks of bevacizumab outweigh its benefits in breast cancer. They are recommending the loss of the breast cancer indication: … Continue reading →

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Natalizumab (Tysabri) and progressive multifocal leukoencephalopathy (PML)

Posted on September 22, 2009 by admin

The FDA have reported on a continuing number of reports of progressive multifocal leukoencephalopathy associated with natalizumab: From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being … Continue reading →

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Metabolic acidosis and zonisamide

Posted on February 24, 2009 by admin

The FDA has issued a warning that zonisamide may be associated with metabolic acidosis in patients with with predisposing conditions or therapies. The young appear more at risk. Further info here. The FDA recommends that healthcare professionals measure serum bicarbonate … Continue reading →

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Clopidogrel and PPIs: reduced efficacy?

Posted on January 27, 2009 by admin

Interesting news from the FDA: The FDA is aware of published reports that clopidogrel (marketed as Plavix) is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way … Continue reading →

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FDA Drug Safety Newsletter

Posted on January 19, 2009 by admin

The FDA Drug Safety Newsletter Volume 2, Number 1, 2009, has been published. It includes three postmarket reviews: Varenicline and Bubropion: Reports of suicidality associated with use of varenicline (marketed as CHANTIX) and bupropion (marketed as ZYBAN and GENERICS) Abacavir: … Continue reading →

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Montelukast (Singulair®) and neuropsychiatric events

Posted on January 16, 2009 by admin

The FDA review of montelukast has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events with montelukast. Although initial analysis of trial data supplied by companies has not shown a link, there … Continue reading →

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ENHANCE study: FDA final review

Posted on January 12, 2009 by admin

The FDA have completed their review of the ENHANCE study, which compared ezetimibe plus simvastatin with simvastatin alone in patients with heterozygous familial hypercholesterolemia: The FDA has completed its review of the final clinical study report of ENHANCE. Following two … Continue reading →

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Rituxan (rituximab) and progressive multifocal leukoencephalopathy (PML)

Posted on September 12, 2008 by admin

The FDA have posted details of a warning by the manufacturer of rituximab concerning a case report of progressive multifocal leukoencephalopathy: Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) … Continue reading →

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