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Legally Mandated Warnings for Oral Contraceptives

Oral contraceptives are unusual in that Congress mandates that each patient receive a package insert with the pills to supplement the information provided by physicians when obtaining informed consent to the use of these pills. Physicians cannot rely on the patient's reading this package insert. Effective informed consent requires that the patient receive the information--not merely that the information be available. Since the patient will not receive the package insert until after the decision to take the pills has occurred, it is arguable that even a patient who has read the insert has already committed to the treatment.

Congress established a warning requirement for these pills because it believed that "the safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use." While this law is aimed at persons dispensing and manufacturing oral contraceptives, it provides a useful benchmark for physicians counseling patients. The federal law requires patients to be given the following information with a prescription for oral contraceptives:

The name of the drug.

A summary including a statement concerning the effectiveness of oral contraceptives in preventing pregnancy, the contraindications to the drug's use, and a statement of the risks and benefits associated with the drug's use.

A statement comparing the effectiveness of oral contraceptives to other methods of contraception.

A boxed warning concerning the increased risks associated with cigarette smoking and oral contraceptive use.

A discussion of the contraindications to use, including information that the patient should provide to the prescriber before taking the drug.

A statement of medical conditions that are not contraindications to use but deserve special consideration in connection with oral contraceptive use and about which the patient should inform the prescriber.\t

A warning regarding the most serious side effects of oral contraceptives.

A statement of other serious adverse reactions and potential safety hazards that may result from the use of oral contraceptives.

A statement concerning common but less serious side effects which may help the patient evaluate the benefits and risks from the use of oral contraceptives.

Information on precautions the patients should observe while taking oral contraceptives, including the following:

A statement of risks to the mother and unborn child from the use of oral contraceptives before or during early pregnancy;

A statement concerning excretion of the drug in human milk and associated risks to the nursing infant;

A statement about laboratory tests that may be affected by oral contraceptives; and

A statement that identifies activities and drugs, foods, or other substances the patient should avoid because of their interactions with oral contraceptives.

Information about how to take oral contraceptives properly, including information about what to do if the patient forgets to take the product, information about becoming pregnant after discontinuing use of the drug, a statement that the drug product has been prescribed for the use of the patient and should not be used for other conditions or given to others, and a statement that the patient's pharmacist or practitioner has a more technical leaflet about the drug product that the patient may ask to review.

A statement of the possible benefits associated with oral contraceptive use. (21 CFR, sec. 310.501)

Physicians should obtain the mandated package insert for each oral contraceptive that they prescribe and discuss the relevant insert with the patient as part of the informed consent for taking oral contraceptives. This is best done with a detailed consent form that follows the package insert for the oral contraceptives being prescribed. The physician should give the patient a copy of the insert irrespective of where she will obtain the pills. If the physician also gives the patient a starter pack or otherwise dispenses oral contraceptives, the law requires that the patient be given a package insert with the pills: "Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient (or to an agent of the patient) to whom the product is dispensed, except that the dispenser may provide the insert to the parent or legal guardian of a legally incompetent patient (or to the agent of either)."


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