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  1. 1
    354205

    FDA notifications. FDA approves new atazanavir labeling.

    AIDS Alert. 2011 Mar; 26(3):33-4.

    In February of 2011, the Food and Drug Administration (FDA) approved new labeling for the antiretroviral drug atazanavir (Reyataz) to include dosing recommendations for treatment of HIV-1 infection during pregnancy and postpartum period. The major revisions to the package insert are summarized in this report, as well as other minor changes made for consistency.
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  2. 2
    796685

    The safety and efficacy of the estrogen patient package insert: A questionnaire study.

    Udkow GP; Lasagna L; Weintraub M; Tamoshunas Z

    JAMA. 1979; 242(6):536-9.

    A questionnaire study of postpartum women receiving a patient package insert (PPI) in anticipation of estrogen therapy for suppression of lactation was conducted in an attempt to determine the impact of PPIs on patients. The questionnaire was designed to assess demographic data, knowledge about estrogens, opinions about the form and readability of the insert, and reactions to the possible risks of estrogen therapy and to the content of the insert. Data on distribution of the insert and acceptance or refusal of estrogen therapy were obtained from the patient's medication record. Respondents were divided into 2 groups -- group 1 was exposed (read all or some of the insert, or the information was explained) and group 2 was not exposed. Oral consent for participation was obtained from 154 postpartum women who did not intend to nurse their babies. 111 respondents were classified as belonging to group 1 and 36 respondents were classified as belonging to group 2. 91.8% of the patients considered their physicians as very important sources of information. Other health professionals were considered very important by a majority of the respondents. 40% considered the PPI to be a very important source, and less than 20% regarded the media and friends to be very important information sources. 42.7% knew why an estrogen product had been prescribed for them. In general, the women were knowledgeable about the proper uses and side effects of estrogens. Exposure to the PPI does transmit information, but this is not reflected in the assessment of therapy or in the actions of the readers. The estrogen PPI cannot be judged to be optimally effective.
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