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PPFA-RECOMMENDED PILL LABELING CHANGE APPROVED BY FDA: PHYSICIANS MAY SAFELY DEFER PHYSICAL EXAM

 NEW YORK, Aug. 18 /PRNewswire/ -- American women should have easier access to oral contraceptives now that a package labeling change for the Pill has been approved by the U.S. Food and Drug Administration (FDA), according to Planned Parenthood Federation of America (PPFA). The package insert language, which advises physicians that they can safely defer a physical examination when prescribing oral contraceptives, is based on a recommendation made by PPFA.
 "This labeling change is a welcome and commendable means of improving women's access to contraceptive services," said Dr. Michael Policar, PPFA's vice president for medical affairs. The FDA's action is the result of an advisory from the Fertility and Maternity Health Drugs Committee.
 The Pill -- with nearly 11 million users -- is the most popular reversible method of birth control in the United States.
 The FDA-amended labeling for oral contraceptives reads: "The physical examination ... may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs."
 Labeling on approved prescription drugs recommends, but does not require, clinicians to dispense drugs in a particular manner. The FDA previously had advised clinicians to perform a physical examination prior to dispensing oral contraceptives.
 The new labeling advises clinicians that they may defer the examination. It suggests, however, that they follow guidelines similar to Planned Parenthood's, which include: taking a full medical history, performing a blood pressure test, and providing the patient with full information about the drug. For women over the age of 30, Planned Parenthood recommends a breast examination, as well.
 According to Policar, one reason PPFA sought this labeling change was because of "wide-spread concern that fear of pelvic exams was preventing many young sexually active women from seeking oral contraceptives."
 He added that a woman also may delay a pelvic examination due to scheduling problems or because she seeks medical care during her menstrual period.
 Planned Parenthood proposed the labeling change to the FDA and the broader medical community only after medical studies convinced the reproductive health care organization to change its own medical standards to allow its clinics to defer the examination.
 "Scheduling a pelvic examination any time within the first 90 days a woman is on the Pill is a procedure that many Planned Parenthood clinics have routinely -- and successfully -- followed for some time," he said.
 Women interested in oral contraceptives may make an appointment at their nearest Planned Parenthood affiliate by calling 800-230-PLAN.
 -0- 8/18/93
 /CONTACT: Roberta Synal of Planned Parenthood Federation of America, 212-261-4660/


CO: U.S. Food and Drug Administration; Planned Parenthood Federation of
 America ST: New York IN: HEA SU:


TW -- DC015 -- 3958 08/18/93 14:02 EDT
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Publication:PR Newswire
Date:Aug 18, 1993
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