ABSTRACT

The first prescription drugs to contain a consumer warning label were isoproteronol inhalation products, used to open breathing airways for asthma patients. If overused, these products could cause a paradoxical reaction, restricting airway flow. In 1968, patients were warned not to overuse the product via a brief warning label attached to the medication package (Morris, 1977). In the 1970s, a few other medications, such as birth control pills and estrogen replacement treatments, were added to the list of prescription drug products requiring patient information. Although the original warning label for oral contraceptives sought to inform women about the risks of the medication in light of the conditions under which the product was used, these products were not used to treat or prevent disease. Instead, they represented a lifestyle choice and “patient consent” (i.e., assurance that the patient was informed about the medication’s risks and made an informed choice) as the main rationale for the patient label (Morris, Mazis, & Gordon, 1977). The original warning label was in the form of a brief one-paragraph warning attached to the medication vial (often a dial-pack) and a longer brochure provided by the physician that contained more extensive information. Later versions relied on a longer (several pages worth) of information packaged with the medication.