MHRA issues warnings over statin side-effects

10 Nov 09

The UK drug regulator has announced it will amend both the summaries of product characteristics and patient information leaflets to include warnings about side-effects caused by the drugs, including depression, sexual dysfunction and lung conditions.

In its November Drug Safety Update, the MHRA said a European-wide review on statins conducted in February 2008 found there was a need for fresh advice and information on the side-effects of statins.

‘The headline message from the review was that the balance of risks and benefits of statins remains positive,’ it stated.

‘However, the review also identified the need for the product information for all statins to reflect the issues identified from analyses of clinical trial and post-marketing data from adverse drug reactions. These included sleep disturbance, memory loss, sexual disturbances, depression, and interstitial pneumopathy.

‘On the basis of the data examined for individual statins and the class as a whole, the review concluded that there is sufficient evidence to support a possible causal relationship between statin use and the above adverse reactions.’

GPs are also warned to ‘be aware of the changes’ and discuss them with patients.

Dr Stewart Findlay, a GP in Bishop Auckland, County Durham, and a member of the Primary Care Cardiovascular Society board, said: ‘Sleep disturbances are quite common in primary care, but the others are not that common.'

'Generally, statins are well-tolerated drugs, but this might prompt us to keep an eye out. If a condition comes on soon after statins are started, it might be worth stopping them to see if it improves.’