Table 2.
Comparison of US market removed drugs with US drugs carrying a boxed warning11
| Characteristic | US Market Removed Drugs | Drugs With an FDA Boxed Warning11 |
|---|---|---|
| Variety of drugs and indications | Broad variety of drugs, drug classes, and indications | Likewise broad distribution across therapeutic areas |
| Frequently affected therapeutic areas | Central nervous system, anti-infective drugs, analgesics and immunomodulators, cardiovascular, and renal drugs | Cardiovascular drugs and central nervous system drugs frequently represented |
| Usage patterns of affected drugs | Both widely prescribed and niche/obsolete drugs affected | Frequently used drugs prominently represented |
| Frequently represented drug classes | COX inhibitors (n = 13), fluoroquinolones (n = 10), H1 receptor antagonists, µ-opioid receptor agonists | COX inhibitors and fluoroquinolones also frequently represented |
| Major adverse effect categories | Hepatotoxicity, cardiac adverse effects, and hematological toxicity are highly prevalent | Cardiac and cardiovascular adverse effects are the most prevalent |
| Relation between adverse effects and indication | Adverse effects may be related to the indication field or completely unrelated | Similar observation reported |
| Pattern of adverse effects leading to regulatory action | Often one dominant serious adverse effect leads to withdrawal | Often multiple severe adverse effects lead to the implementation of a boxed warning |
| Risk-benefit considerations | Withdrawn drugs usually removed because of significant safety or efficacy issues | Boxed warnings indicate serious risks but a remaining positive risk-benefit ratio |
| Regulatory consequence | Drug discontinuation or withdrawal from the US market | Drug remains approved but carries the strongest FDA safety warning |
| Market status of affected drugs | Drugs removed from the market or discontinued | Drugs remain available with prominent safety warning |
The listed criteria include drug characteristics, prevalent drug classes, and adverse effects, as well as regulatory consequences. Green indicates high similarity, yellow indicates moderate similarity, and orange indicates low similarity.