FDA announces 'iPLEDGE' program for Accutane
On August 12th the FDA announced that starting December 31, 2005, thousands of Accutane users, plus the doctors who prescribe it and stores that sell it, must enroll in a national registry that ensures they understand all the drug’s risks, and take special steps to avoid the most notorious one, Accutane-damaged pregnancies.
Free Accutane Case Evaluation If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities. The drug may also trigger or worsen depression or suicidal thoughts, according to a warning on the pills’ label that the FDA strengthened Friday and that patients are to receive as part of the new program.
Under iPLEDGE, every patient, man or woman, must enroll in a computerized registry starting December 31st to receive Accutane or a generic version of the drug isotretinoin. Doctors, drugstores and wholesalers must also register.
All patients seeking a prescription for Accutane must sign a document informing them of all of Accutane’s side effects, agree to monthly doctor visits for refills and agree not to share the pills with anyone. The doctor registers each patient into the iPLEDGE database, giving them a special identifying code number and writes the prescription.
Women of childbearing age must undergo additional steps including two tests to ensure that they are not currently pregnant and monthly pregnancy testing (by a physician) before each refill. These women must also agree to use two forms of birth control while using Accutane and must self-register on iPLEDGE, in addition to the doctor’s registration, to report what type of birth control they are using.
Pharmacists must check the database before filling a prescription. Accutane maker Hoffman-LaRoche and generic manufacturers will monitor drugstores and wholesalers and are supposed to cut off violators sales supplies.
The registry actually opens August 22nd to give users time to learn how it works before it becomes mandatory. On that date, patients may enroll at www.ipledgeprogram.com or by phone at 1-866-495-0654. (AP Medical Writer Lauran Neergaard)
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