Archive for 'Pharmacovigilance' Category

Regulation and drug safety

By Anthony - Last updated: Saturday, January 28, 2012

Modern day drug safety in developed countries does not generally involve poor product quality. This isn’t to say problems don’t arise, the FDA and MHRA had to shut Chiron’s vaccine plant in Liverpool for some time. Followers of the MHRA Drug Alerts service will also be aware of the drug recalls associated with manufacturing problems […]

Nazis, concentration camps, & thalidomide

By Anthony - Last updated: Thursday, November 3, 2011

In a piece on what ever happened to the thalidomide babies Frederick Dove raises the issue of a Nazi link to thalidomide (Contergan was its German trade name) . This is important because the victims of thalidomide may then be able to leverage greater support and help for survivors. It is worth noting that German […]

ISOP 2011

By Anthony - Last updated: Saturday, October 29, 2011

This week I have been at the International Society of Pharmacovigilance‘s 2011 meeting in Istanbul. My colleagues and I have been presenting data on missed doses (adults and children), causality and prevention of adverse drug reactions, the use of rivaroxoban for total knee replacement, and patient internet accounts of serious Stevens Johnson Syndrome and Toxic […]

Xigris Grounded

By Anthony - Last updated: Tuesday, October 25, 2011

Drotrecogin alfa (Xigris) has been withdrawn from the market, because it doesn’t work. It was granted a licence in the full knowledge that insufficient data existed for a standard licence, and was under yearly review by the European Medicines Agency. It was restricted for use in those with severe sepsis and at least two organ […]

EU Pharmacovigilance

By Anthony - Last updated: Wednesday, October 13, 2010

The BBC’s Democracy Live have put up the EU debate on pharmacovigilance. Interestingly, one of the outcomes is some legal backing to a black symbol, with the statement “This medicinal product is subject to additional monitoring.” In the UK, that is the black triangle. I hope it doesn’t change. EU documentation is here. Not particularly […]

Are lawsuits the way to ensure drug safety?

By Anthony - Last updated: Thursday, October 7, 2010

Asks Andre Picard in the Globe and Mail. The answer is “no”. Canada and the US arguably reach for the law suit more often than Europe, but it isn’t clear that drug safety in Europe is any less effective for that. For example, despite the difference in culture, it is the US that has left […]

Paracetamol: Recall bias and media bias

By Anthony - Last updated: Friday, October 1, 2010

Just a short note. A couple of years ago there was a great deal of fuss about paracetamol and a possible link with asthma in children [Lancet]. The study reported on was a large retrospective study (205 487 children) involving surveying parents about their children’s previous paracetamol use and symptoms of asthma. There is an […]

Yellow Card Scheme advert

By Anthony - Last updated: Saturday, November 7, 2009

Report here: http://www.yellowcard.gov.uk

Fly posting

By Anthony - Last updated: Tuesday, October 6, 2009

I’m presenting a couple of posters at the International Society of Pharmacovigilance Conference this week. One is concerned with possible neuropsychiatric reactions to varenicline, and the other uses the DoTS ADR classification system to analyse reports of angioedema with angiotensin-II receptor antagonists. Further details at the links in the text.