iPLEDGE My Allegiance to…Accutane?
For those suffering with acne, Accutane can be a miracle drug, potentially curing the problem, or at the very least greatly reducing it to a manageable level that can be handled with traditional treatments. Where the miracle abruptly stops is at the point where Accutane poses serious risks to women who get pregnant while taking it because severe damage to the developing fetus is to be expected. Despite ongoing efforts over the past 20 years to help physicians warn their female patients about the dangers of getting pregnant while taking Accutane, more than 120 pregnancies still occur among those patients almost every year. In response to this alarming statistic, the FDA created a system called iPLEDGE for female patients, which requires a combination of comprehensive preventive measures such as mandatory pregnancy testing, and, for both physicians and pharmacies, extensive documentation responsibility.
Some of the new mandatory stipulations, effective as of March 1, 2006, are as follows: Accutane must be distributed only by iPLEDGE-registered wholesalers, dispensed only by iPLEDGE-registered and -activated pharmacies, prescribed only by iPLEDGE-registered and -activated prescribers, and prescribed/dispensed only for iPLEDGE-registered and -activated patients.
For females of childbearing potential, Accutane must be prescribed initially on confirmation of two negative pregnancy tests (one screening test conducted when the decision is made to pursue qualification of the patient for Accutane, and a second confirmation test conducted at a certified laboratory within seven days of the office visit). Subsequent prescriptions are contingent on confirmation of a monthly negative pregnancy test conducted at a certified laboratory. Every month, documentation must include a signed statement from the patient indicating the two chosen forms of contraception that will be used. Further, all Accutane users must now enroll by telephone at (866) 495-0654 or through the Internet at http://www.ipledgeprogram.com in order to receive the drug.
These precautions, though cumbersome, will save many women the ordeal and torment of having a malformed baby. I still want to emphasize that for those with severe acne who can comply with these requirements, the end of the road can be smooth, unblemished skin. There are serious side effects associated with Accutane, but the potential for having normal skin can be worth it—I know it was for me.
Source: Paula Begoun