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  1. Postmarket Drug Safety Information for Patients and Providers

Isotretinoin (marketed as Accutane) Capsule Information

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 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 1-866-495-0654.

  • 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 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 p.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 p.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 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 isotretinoin’s 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, www.iPLEDGEProgram.com, 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 and agreement to use contraception.

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 or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. 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. [Action taken 8/12/2005 Labeling revision]

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Isotretinoin is marketed under these names:

  • Accutane
  • Amnesteem
  • Claravis
  • Sotret

To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.

 FDA Warning:
Risks of Buying Accutane (isotretinoin) over the Internet

Isotretinoin is a potentially dangerous prescription medicine that should only be taken under the close supervision of your healthcare professional and pharmacist. If you are pregnant or may get pregnant, isotretinoin can cause birth defects, miscarriage, premature births, and death in babies. Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely. When these procedures are ignored, isotretinoin can cause serious and harmful side effects. Patients taking isotretinoin may experience side effects including bad headaches, blurred vision, dizziness, nausea, vomiting, seizures, stroke, diarrhea, and muscle weakness. Additionally, serious mental health problems, such as depression and suicide, have been reported with isotretinoin use.

  • You should NEVER buy Accutane (isotretinoin) or any of the generic versions of Accutane without first seeing your healthcare professional.
  • You should NEVER take Accutane (isotretinoin) or any of the generic versions of Accutane if you are pregnant or trying to get pregnant or could accidentally become pregnant.
  • Some websites sell prescription drugs without a prescription. This is illegal and DANGEROUS.

Labeling and Regulatory History from Drugs@FDA

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