Contraindication- Product Label

By contrast, a “contraindication” for a medicine refers to a specific situation in which the medicine should NOT be taken or administered—defined as circumstances under which using the medicine entails a substantial risk of harm that clearly outweighs any possible therapeutic benefit. To put this another way, the Contraindications section describes the kinds of cases where patients would have a substantial risk of being harmed by a medicine without the potential for sufficient benefit to make that risk acceptable. The Warnings section of the PI will also include a brief mention of any contraindications (with cross-references to this section), and will provide more detail about any
specific adverse reaction that is involved.

Various criteria can be considered for determining when a medicine is contraindicated:
• Patient age (especially infants or young children, or elderly individuals, for whom the demonstrated effectiveness might be less, or the risk of harmful adverse reactions greater,than for other ages).
• Patient gender (a risk may be higher, or the effectiveness of the medicine less, for male versus female individuals).
• Concomitant therapy (other medicines or treatments already being taken might lead to harmful adverse reactions if this medicine were taken at the same time).
• Disease state (the risk-benefit relationship might be different for different severities or stages of the disease to be treated).
• Other condition (a specific coexisting disease or the general condition of a patient might make use of a medicine potentially more hazardous, or less effective against a disease).
• Patient hypersensitivity to the medicine.

A contraindication is a judgment by regulators—after reviewing the available medical evidence—about the benefit-risk relationship of using that medicine under specific circumstances. For example,
a medicine may be approved for treatment of advanced stages of a life-threatening disease, despite
a known risk of serious adverse reactions, if a sufficient level of effectiveness has been demonstrated and no safer effective treatment options exist. In contrast, that same medicine may be contraindicated for patients in whom the same treated disease is less advanced, if it can be treated with other medicines that are equally effective but have a lower risk of serious side effects. It is important to remember that whether a medicine is right for you, at the right time, and for your condition, is always a decision ultimately made by you and your doctor. Note that, according to FDA regulations,contraindications are issued regarding medicine hazards that are known—because they have been demonstrated in studies and/or clinical experience—not for hazards that are simply theoretically possible.