admin October 12th, 2009
The MHRA have issued the October 2009 Drug Safety Update.
- Ceftriaxone: incompatibility with calcium-containing solutions—updated advice
- High-dose cyproterone acetate: potential risk of (multiple) meningiomas
- Yellow Card Scheme update
- Human papillomavirus (HPV) immunisation programme—first year safety review
- Smoking and smoking cessation: clinically significant interactions with commonly used medicines
- Aspirin: not licensed for primary prevention of thrombotic vascular disease
- Varenicline and suicidal behaviour: cohort study provides some reassurance
admin October 6th, 2009
In recent years concerns about neuropsychiatric adverse drug reactions associated with varenicline have been raised both in the UK and the US. In Europe warnings were issued by EMEA. A recent BMJ study using the GPRD database has cast some doubt on the strength of such an association. We recently performed an analysis of the utility of using spontaneous patient reports of suspected adverse reactions to varenicline left on a number of blogs. Here is a poster we are presenting at the International Society of Pharmacovigilance conference this week.
Varenicline: evaluation of the utility of spontaneous consumer reports of suspected adverse effects filed on internet sites [PDF]
admin October 6th, 2009
Angioedema is a rare serious adverse drug reaction (ADR) to angiotensin-converting enzyme inhibitors (ACE-I), with an incidence of 0.1% to 1.0%. If untreated it can be life-threatening. Debate exists over the safety of switching to an angiotensin-II receptor blocker (ARB), due to case reports of angioedema, and the mechanism of ARB-associated angioedema. The DoTS system of ADR classification provides a structured template for examining the Dose and Time relationship, and potential Susceptabilities to an ADR.
Here is a poster we are presenting at the International Society of Pharmacovigilance conference this week.
Angioedema associated with angiotensin-II receptor blockers: a DoTS classification
and analysis [PDF].