Ipledge program for accutane

It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used. 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. 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. 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.

Pharmacies will not be able to obtain an RMA number to dispense isotretinoin between December , Important changes for Patients : Starting on December 13, , patients will be assigned to one of two risk categories: patients who can get pregnant and patients who cannot get pregnant.

Patients will also have the option of presenting a unique QR code at the pharmacy on their smartphone instead of providing their iPLEDGE identification number. Any patient whose isotretinoin prescription RMA i. Eastern on Friday, December 10, 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. The isotretinoin manufacturers have informed FDA that, during this time, their website will be completely unavailable.

The previous website shut down December 10, and the new one launched December 13, the first day for the new approach. While she and other dermatologists said they offered input previously on how to make the transition go more smoothly, no one seemed to want that help. That was before the scheduled meeting today. Neil S. They had a minute wait to get to a human. All program materials and educational tools will be now available to you at the click of a button.

The process of reverification [required] is not that hard, but a lot of people have trouble even logging into the platform. The glitches are delaying prescriptions for established patients and new ones as well, Yeung said. Existing patients who can get pregnant have 7 days after their negative pregnancy test to get their prescription filled.

Twitter users had a lot to say, as well. What a disaster for patient care! Several called for the FDA to immediately halt the program and let physicians manage the risk until the platform can be improved. Tomecki, MD, issued a statement expressing disappointment about the transition.