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  • Title: Medicolegal issues surrounding Depo-Provera easily overcome.
    Journal: Contracept Technol Update; 1992 Jan; 13(1):16, 18. PubMed ID: 12343460.
    Abstract:
    Even though the Food and Drug Administration (FDA) does not label Depo-Provera as a contraceptive, this fact should not preclude clinicians from prescribing it as such. The lack of FDA approval may deter clinicians from prescribing Depo-Provera as a contraceptive, but legal precedents for prescribing the drug as a contraceptive do exist. As Dr. Andrew M. Kaunitz of the University of Florida Health Sciences Center explains, it is not uncommon for physicians to prescribe drugs for unlabeled indications. Moreover, the American Medical Association (AMA) maintains that such a practice is entirely proper, as long as it is based on "rational scientific theory, reliable medical opinion, or controlled clinical studies," and as long as the FDA does not mandate that physicians may only prescribe the drug for an officially labeled use. Drug labeling, says the AMA, does not necessarily set the standard for what is good medical practice. Clinicians, however, must take the necessary steps to protect themselves from liability when using Depo-Provera. The AMA warns that official drug labeling may be used as evidence in a liability lawsuit. Through computerized search programs, Kaunitz has investigated US court decisions concerning the use of Depo-Provera as a contraceptive. He found no litigation cases resulting from Depo-Provera's official status with the FDA. He did, however, find lawsuits resulting from physician failure to diagnose pregnancy at the time the patient received Depo-Provera and physician failure to advise the patient about Depo-Provera's side effects--especially the irregular bleeding patterns. Kaunitz advises that informed consent forms should indicate that Depo-Provera is not labeled as a contraceptive in the US and should point out the major side effects.
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