My Clinical Trials Diary

The capsule costs pennies, contains a simple cocktail of medicines, and halves the number of strokes and heart attacks. Doctors want to hand it out in the first mass medication for the middle-aged in Britain. So why are the big drug companies so uninterested? The magic bullet, containing five medicines in a single capsule, sharply reduced cholesterol and blood pressure levels and has the potential to "halve cardiovascular events in average middle-aged individuals", the researchers say. The finding is a major boost for a medication with huge potential against the worldwide epidemic of heart disease and stroke. Doctors say that, if further trials prove successful, all men aged over 50 and women aged over 60 should be offered the pill in what would be the first example of mass medication for the middle-aged in Britain. Yet no Western pharmaceutical company has shown interest in developing the so-called polypill because it does not promise big profits. It would sell for pennies b...

GSK adds CHF boxed warning on Avandia label Friday, August 17, 2007 10:00 IST  Philadelphia, Pennsylvania GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of type 2 diabetes. This approval allows GSK to implement changes in the label for Avandia (rosiglitazone maleate) as previously committed.  The label will contain a boxed warning, which increases the prominence of an already existing warning for all medicines in the TZD class on the risk of congestive heart failure (CHF), a well known and well characterized risk in this class of medicine. The boxed warning also will note that TZDs are not recommended in patients with symptomatic heart failure, and that initiation of TZDs in patients with established NYHA class III or IV heart failure is contraindicated.  The contraindications have also been updated regarding initiation of Avandia in patien...