marketing impact of a boxed warning on a drug

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First off, what is a boxed warning, also sometimes called a black box warning. A boxed warning calls attention to a serious adverse reaction observed in patients taking a drug. The severity of the adverse reaction is measured relative to the therapeutic benefit of the drug. Typically, the serious adverse effect will be identified during clinical trials. Inclusion of the boxed warning on the packaging and within the prescribing information will be part of the approval of the drug. So, the FDA will approve the drug while also requiring appropriate safety labeling in the form of the boxed warning. Beyond calling attention to the potential safety risk, the warning may include information on how the likelihood of the risk can be reduced through appropriate use of the medication.
The term “boxed warning” is literal. The warning is literally in a black box. The text of the warning is often in a different font or style so that it stands out from other information on the packaging. A boxed warning is not small legalese text in the bottom corner of the label. The boxed warning is very prominent.
Boxed warnings are more common with life-saving or life-extending drugs. Physicians and patients are typically more accepting of potential risks as long as the drug carries essential benefits. A drug that treats a less severe condition, perhaps seasonal allergies, would likely not be approved if it had a risk that warranted a boxed warning. Furthermore, even if the high-risk allergy medication were approved, a physician would be likely unwilling to prescribe the medication because of the disproportionate risk relative to the drug’s benefit. There are some drugs, chronically administered drugs, with safety risks that came to light after approval and had a boxed warning added to their labeling. Both celecoxib (a pain reliever) and fluoxetine (an anti-depressant) are still available and regularly prescribed despite the additional safety concerns. Rosiglitazone (a diabetes drug) also had an added boxed warning. It is still available in the United States but was withdrawn from most European markets. So, adding a boxed warning to a drug is not necessary the death knell for that drug. A boxed warning, however, will almost certainly impact the marketability of the drug if there are other treatment alternatives.