FDA eases access to Accutane.Women seeking an acne acne, common inflammatory disease of the hair follicles and sebaceous glands characterized by blackheads, whiteheads, pustules, nodules and, in the more severe forms, by cysts and scarring. The lesions appear on the face, neck, back, chest, and arms. medicine that can cause severe birth defects birth defects, abnormalities in physical or mental structure or function that are present at birth. They range from minor to seriously deforming or life-threatening. A major defect of some type occurs in approximately 3% of all births. may find it a little easier to fill their prescription, after FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. announced changes designed to ease access to the drug. A program called iPledge was designed to ensure that every user of Accutane or its generic competitors--and every doctor who prescribes it and every pharmacy that sells it--follows strict rules to make sure that women don't get pregnant while on the drug. Among those rules are month-by-month prescriptions based on passing pregnancy tests pregnancy test Any test used to detect or confirm pregnancy; in early pregnancy, all PTs measure hCG, the developing placenta's principal hormone, which is detectable as early as 6 days after fertilization; in clinical laboratories, serum levels of hCG are . But last summer, FDA heard evidence that iPledge hasn't ended the problem. There were 122 pregnancies in the program's first year and another 37 in the four months since. Another 19 pregnancies occurred in women who managed to get the drug despite never enrolling in iPledge. Still, in October FDA agreed to a few changes to the program, and announced Dec. 5 that iPledge is now implementing these changes: Women of childbearing child·bear·ing n. Pregnancy and parturition. child  bear ing adj. age who don't fill a prescription within
seven days of a pregnancy test will be allowed to get another test and
then fill the prescription--with the exception of the initial
prescription. Until now, those who didn't act within seven days
were frozen out of the program for the next 23 days.
Those women will have to fill the prescription within seven days of a pregnancy test rather than within seven days of first seeing their doctor. |
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