Etodolac’s withdrawal from the market wasn’t solely due to one factor, but rather a confluence of safety signals reflected in adverse event reports. Gastrointestinal issues, such as ulcers and bleeding, featured prominently. Reports showed a higher-than-acceptable incidence of these complications compared to other NSAIDs. Specific numbers varied across studies but consistently exceeded acceptable thresholds for continued marketing.
Cardiovascular Risk
Concerns regarding cardiovascular risks also contributed to the decision. Studies revealed a potential increased risk of heart attacks and strokes in patients using etodolac, although the magnitude of this risk relative to other NSAIDs varied based on study design and patient population. The FDA and other regulatory agencies carefully considered these findings when reviewing etodolac’s safety profile.
Hepatotoxicity and Other Adverse Events
Reports of liver damage (hepatotoxicity) also emerged. While rare, these cases necessitated close monitoring. Additional reported adverse events included allergic reactions, ranging from mild skin rashes to serious anaphylaxis. The cumulative weight of these adverse event reports, along with the availability of safer alternatives, ultimately led to the drug’s discontinuation.
