Principles and Practice of Pharmaceutical Medicine

informational sources as needed. A case series
of rhabdomyolysis associated with cerivastatin
could have been constructed and analyzed to
evaluate the company’s post-marketing experi-
ence, and clinical trial data could have been
examined if additional follow-up was required.

Summary

An evaluation of the FDA’s SRSþAERS data-
base, through the end of the second quarter of
2005, showed that there was an increased risk of
rhabdomyolysis associated with the use of all the
statins. The frequency and EB05 were signifi-
cantly higher for cerivastatin, compared to the
other statins. On August 8, 2001 the FDA had
announced that cerivastatin was being voluntarily
withdrawn from the US market by its manufac-
turer, because of reports of sometimes fatal rhab-
domyolysis.

Caveats

Data source caveats

Reports may be submitted using either a drug’s

generic or brand name. As brand names may

differ among countries, all standard signaling

activities are performed using the generic drug

name, as it appears coded in the database. Recon-

ciliation among different names/formulations does

not occur on a routine basis.

It should be noted that drug mentions are used to

determine concomitant and co-suspect medica-

tions. This means that duplicate mentions of a

drug within a specific case may result in double

counting. Thus, all drug mentions should be con-

sidered approximations.

Important limitations of this regulatory database

include general underreporting of post-marketing

events and reporting bias. Factors such as publicity,

length of time the drug is on the market and

Figure 40.4 The cumulative annual number of cases of rhabdomyolysis in the AERS database associated with the
statins

40.5 CASE STUDY 551