Letters

Long term safety of statins should be monitored

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.333.7569.656 (Published 21 September 2006) Cite this as: BMJ 2006;333:656
  1. Steven J Haas, honorary research fellow (steven.haas{at}med.monash.edu.au),
  2. Rosana Hage-Ali, research assistant,
  3. Brian G Priestly, director, Australian Centre for Human Health Risk,
  4. Andrew Tonkin, head, cardiovascular unit,
  5. Lisa Demos, senior research fellow,
  6. John J McNeil, head,
  7. Mark Nelson, chair, discipline of general practice
  1. Monash University, Department of Epidemiology and Preventive Medicine, Central and Eastern Clinical School, Alfred Hospital, 89 Commercial Road, Melbourne, VIC 3004, Australia
  2. Monash University, Department of Epidemiology and Preventive Medicine, Central and Eastern Clinical School, Alfred Hospital, 89 Commercial Road, Melbourne, VIC 3004, Australia
  3. School of Medicine, University of Tasmania, Private Bag 33, Hobart, Tasmania 7001, Australia

    EDITOR—We agree with Ravnskov et al that little is known about the adverse effects of high dose statins but also propose that little is known about the long term safety of more modest doses used at present.1 Lifetime use of statins may equate to treatment for 30 years or more.2 As said by the authors, multicentre, large scale trials have established efficacy of these agents but are much less reliable in detecting uncommon serious adverse outcomes such as cancer.

    Recent studies provide reassurance about the safety of statins with respect to all cause carcinogenicity in the short term34 and up to 10 years.5 However, although the length of postmarketing surveillance remains quite short compared with the medically accepted latency period for cancer of 20 years,2 it seems prudent to establish systems examining and linking large databases to allow extended follow-up for malignancy. Such monitoring can also help ascertain whether any class effect or dose response exists and whether certain categories of carcinogenicity are influenced by statins either favourably (as shown by some case-control studies) or deleteriously.

    These data linkage systems should include a variety of stakeholders, among them regulatory authorities from different countries and the pharmaceutical industry, all cooperating in the provision of more robust information in this and other important areas of pharmacovigilance. Recent issues surrounding the long term uncertainty of cyclo-oxygenase-2 inhibitors and hormone replacement therapy have highlighted that drug safety must be proved rather than assumed, especially for drugs used very widely and long term.

    Footnotes

    • Competing interests SJH has received assistance via an Australian National Health and Medical Research Council public health postgraduate research scholarship, scholarship application ID No 237059. AT has received funding for studies and speakers' fees from pharmaceutical industry companies including AstraZeneca, Bristol-Myers Squibb, Merck Sharp and Dohme, Pfizer, and Sankyo. MN has received funding for studies and consultancies from pharmaceutical industry companies including AstraZeneca, Bayer, Sanofi-Aventis, Sanofi-Synthelabo, Bristol-Myers Squibb, Merck Sharp and Dohme, and Pfizer. JJMcN has served on advisory boards for Pfizer, GlaxoSmithKline, Johnson & Johnson, Bristol-Myers Squibb, Schering-Plough, Sanofi-Aventis, and Merck Sharp and Dohme.

    References

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