Rosuvastatin adverse reactions reported more often
Reports of adverse drug reactions associated with the lipid-lowering agent rosuvastatin (Crestor) are more common than those associated with several other statins, US researchers have shown.
However, their conclusion that this finding supports concerns about rosuvastatin’s
relative safety has been called into question by the author of an editorial
published
alongside the study.
The researchers reviewed reports of adverse events associated with rosuvastatin,
atorvastatin, simvastatin and pravastatin that had been received by the
US Food and Drug Administration between October 2003 and September 2004
(the first year during which rosuvastatin was available in the US). They
also collected data from each comparator drug’s first year of marketing.
For either timeframe used, rosuvastatin was several times more likely
to be associated with ADRs.
The researchers acknowledge the existence of possible confounding factors.
For example, reporting rates for ADRs associated with rosuvastatin may
have been influenced by negative publicity surrounding the safety profile
of this drug and by heightened public awareness. Nevertheless, the researchers
conclude that their finding raises concerns about rosuvastatin’s
safety.
Scott Grundy, of the University of Texas Southwestern Medical Centre,
Dallas, and
author of the accompanying editorial, asks whether ADR data alone should
override other evidence when absolute rates of ADR reports for all statins
are low. “Adverse event reports can be useful for identifying signals
of drug toxicity. They are much less useful for quantifying relative
risk of different drugs of the same class,” he writes.
The paper and editorial are accessible via PJ Online (www.pjonline.com/links/pj). |
The
Pharmaceutical Journal
Acrobat
Reader