Thank goodness for the small but awfully potent Drugs and Therapeutics Bulletin (DTB). On its front page this month, it notes that new warnings about side effects of statins have still to be included in the patient information leaflets about them. These side effects include sexual dysfunction, memory loss and depression.
In February 2008, they say, the Medicines and Healthcare products Regulatory Agency (MHRA) decided, following a review of clinical trials, reports of adverse drug reactions, and publications, they were to update the leaflet ” to reflect a number of different side effects as class effects of all statins”.
I send off yellow cards on a slow but continuous basis: Fatigue, low mood and memory problems are common enough complaints - and it can be difficult to guide people about what we think could be reasonably attributable to the drugs, and what might just have happened anyway.
Far better information is gathered when multiple sources of information are collated – and I would like to think that the cards are an important part of improving the accuracy of the information patients get.
But the DTB are saying that there has been none of the promised update in side effects in the patient information leaflets throughout the EU. Instead, it appears that “one of the MA (market authorisation) holders was not in agreement”.
So it appears a pharmaceutical company has been capable of stopping patients getting more accurate information about side effects and safety of statins. Isn’t this ludicrous?
Margaret McCartney
Clive Cookson
Andrew Jack