FDA Warning: Don't Buy Accutane Over the Internet. Ipledge Update (March 15, 2018 Please be advised that the isotretinoin manufacturers have informed FDA that the ipledge rems Program website will undergo maintenance on accutane suicidal March 17 and March 18, 2018. The isotretinoin manufacturers have informed FDA that, during this time, their website will be completely unavailable. The ipledge Program Contact Center will be open during its normal hours of operation (9:00 AM to 12:00 AM midnight ET, Monday through Saturday) and will be able to answer general information questions. . The ipledge Program Contact Center is available toll-free by calling. Specifically, Prescribers will not be able to interact with the ipledge Program, Patients will not be able to complete Patient Monthly Comprehension Questions, and. Pharmacies will not be able to obtain a Risk Management Authorization (RMA) number. Prescriber Action: Prescribers and their designees should ensure that any accutane suicidal patient whose isotretinoin prescription RMA (i.e., ipledge authorization) expires March 17 or March 18, 2018 is instructed to obtain their prescription before 11:59.m. (Eastern) on March 16, 2018. The isotretinoin manufacturers anticipate that their system will be available again starting Monday, March 19, and FDA will update this posting accordingly. Patient Action: Any patient whose isotretinoin prescription RMA (i.e., ipledge authorization) expires during the weekend of March 17-18, 2018 must obtain their prescription before 11:59.m. (Eastern) on Friday March 16, 2018. . If the RMA expires before the prescription is picked up from the pharmacy, the patient must go back to their prescriber and start the authorization process again. Information on Isotretinoin, isotretinoin is marketed as Absorica, Claravis, Amnesteem, Myorisan, and Zenatane, and is sometimes referred to by its former brand name, Accutane. . Isotretinoin is a prescription medication used to treat severe recalcitrant nodular acne. While isotretinoin is beneficial for some patients, there are risks associated with this drug. . Specifically, isotretinoin is highly teratogenic (i.e., causes severe birth defects) and, therefore, is approved for marketing only under a restricted-distribution risk evaluation and mitigation strategy (rems called the ipledge Program. Ipledge rems Program for Isotretinoin Products. The ipledge rems Program was originally implemented in early 2005. It is a shared system program, meaning that it accutane suicidal includes all FDA-approved isotretinoin. . The goals of the ipledge rems Program are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoins serious risks and safe-use conditions. . It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used. In an effort to provide timely isotretinoin information to prescribers, pharmacies, patients, and distributors, the FDA will post any related updates on isotretinoin and the ipledge rems Program on this page. Please see the ipledge rems website, m, for up-to-date and detailed information about the program. Ipledge Update (10/22/2010 Today, FDA approved iPledge as a Risk Evaluation and Mitigation Strategy (rems) in accordance with the Food and Drug Administration Amendments Act of 2007 (fdaaa). This approval does not substantively change the program for patients, prescribers, dispensers, and wholesalers for approved uses of isotretinoin. Fdaaa required the conversion to rems of those RiskMAPs approved before fdaaa was enacted that contained certain features such as those of the iPledge program requiring prescriber and pharmacist certification, and documentation of safe use conditions before the drug can be dispensed, including pregnancy testing. Ipledge Update (10/2007) : FDA is providing an update about ipledge, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). FDA approved several changes to the program. See ipledge Update, fDA alert 7/2005 : Suicidal Thoughts or Actions : In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary.
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