Researchers examined three cases in which major adverse events led to drugs being taken off the market. The cases involved rofecoxib, cerivastatin and troglitazone.
Rofecoxib, marketed as Vioxx, was used as an arthritis treatment for more than five years, with 105 million rofecoxib prescriptions being filled in the United States. However, the drug substantially increased the risk of a heart attack. Based on analyses of healthcare utilization data, 27,500 heart attacks could have been avoided had a drug safety monitoring system been in place, according to researchers.
An active drug surveillance system could have also helped avoid 190 cases of a serious complication called rhabdomyolysis that arose from cerivastatin, a drug used to lower cholesterol. It could have also helped avoid 264 cases of liver failure caused by troglitazone, a diabetes medication.
In terms of cost-savings, a drug safety surveillance system could have saved the following:
• In the case of rofecoxib: $773 to $884 million
• In the case of cerivastatin: $3 to $10 million
• In the case of troglitazone: $38 to $63 million
“It is clear that major adverse drug events are not rare,” study authors write. “Investment in active drug surveillance offers protection against the occurrence of such events, which are bound to recur.”
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