To login to iPLEDGE go to and locate the Login section in the middle of the screen. Type your username and password into the appropriate boxes. For example, if your username is ABC123, type exactly ABC123 in the Username box. If your password is 1234, type 1234 in the Password box.
How do I access iPLEDGE questions?
Have Questions? Call our toll-free number 1-866-495-0654.About iPLEDGE.About Isotretinoin.
Is iPLEDGE working again?
FDA approved a modification to the iPLEDGE REMS effective December 13, 2021 with system changes for health care professionals and patients.
What is going on with iPLEDGE?
The Food and Drug Administration has approved system changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin products. The system changes will go into effect starting December 13, 2021 for health care professionals, pharmacies, and patients.
Can Accutane get you pregnant?
Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time.
How do I get my iPLEDGE number?
Patients can access their unique QR code by logging into their account on the iPLEDGE REMS Website . Patients can consult their prescriber, call the iPLEDGE Contact Center at (866) 495-0654 or visit the iPLEDGE website for more information about this change.
Is amnesteem a product in the iPLEDGE program?
Because of Amnesteem’s teratogenicity and to minimize fetal exposure, Amnesteem is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™.
How do I contact iPLEDGE online?
If you do not have access to your account on the website, contact the iPLEDGE call center at 866-495-0654. FDA has issued a CDER statement requesting proposals for solutions from isotretinoin, manufacturers, pharmacies and dermatology organizations.
Is iPLEDGE fixed yet?
The website changes were announced by the FDA on October 8, 2021, stating that it had approved a modification to the iPLEDGE REMS which would take effect on that December 13, 2021, date.
When will iPLEDGE be available?
Isotretinoin manufacturers anticipate the phone and internet systems for the modified iPLEDGE will be available on Dec. 13, 2021,” the FDA noted.
Does Accutane affect weight?
People sometimes mention weight gain or weight loss when talking about Accutane. However, the FDA do not currently list weight change as a side effect of this drug.
Does Accutane affect sperm?
In a study of 50 men (ages 17 to 32 years) receiving Accutane (isotretinoin) therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
Has anyone had a baby on Accutane?
And while the absolute number of pregnancies per year has fallen since the peak of 768 in 2006, it plateaued in 2011. Every year since then, about 200 to 300 isotretinoin users have gotten pregnant, the study found.
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