MHRA-Statins

MHRA (Medicines and Healthcare products Regulatory Agency, U.K.)publishes public assessment report of adverse effects associated with statins

Reference: Drug Safety Update: Volume 3, Issue 4, November 2009

The following is an extract:

The statins licensed for use in the UK include: atorvastatin (brand name Lipitor); fluvastatin (Lescol, Lescol XL); pravastatin (Lipostat); rosuvastatin (Crestor); simvastatin (Zocor, Zocor Heart-Pro, Inegy)

As with any medicine, the use of statins may lead to adverse reactions (side-effects) in some individuals. Evidence suggests that the use of statins may be associated with certain adverse reactions, such as sleep disturbancesb, memory loss, micturition disordersc, sexual disturbancesd, depression and interstitial pneumopathye.

Section 4.4 – Special warnings and precautions for use

Interstitial lung disease

Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8). Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.

Section 4.8 – Undesirable effects

The following adverse events have been reported with some statins:

• Sleep disturbances, including insomnia and nightmares [where this is not already listed]

• Memory loss

• Sexual dysfunction [where this is not already listed]

• Depression

• Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4)

Overall, the review was to address causality for each event (time to onset, de-and re-challenge, presence and absence of confounding factors) and whether the ADRs were dose-related. With regard to sleep disturbances specifically, the review was to address whether events of sleep disturbance were related to the timing of statin dose administration (ie, morning or evening). With regard to memory loss, the review was to address whether events of memory loss with use of statins was short or long term, and whether the memory loss was reversible. With regard to interstitial pneumopathy, the review was to address the need or use of corticosteroids.