FDA Approval Report.

The FDA has approved a strengthened dispersion curriculum for isotretinoin.
This show, called iPLEDGE, is intended to prevent use of isotretinoin during pregnancy.
Isotretinoin (Accutane and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of nascence defects.
Women who are pregnant or who might become pregnant should not take the drug.

Starting December 31, 2005, physicians and patients must registry with the iPLEDGE software system before receiving authority to prescribe or use the drug.
Group action with iPLEDGE requires part visits, counseling, nascence ascendancy, and other responsibilities.
Key requirements for patients include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy investigating.

As of October 31, 2007, wholesalers and pharmacies have had to air passage with iPLEDGE to obtain isotretinoin from a concern, to distribute the set, and to dispense it.

Physicians, patients, and pharmacies can obtain papers noesis and can timber with iPLEDGE via the Internet (http://www.ipledgeprogram.com) or by telecommunication.

A reporting and collecting methodicalness for serious adverse events associated with the use of isotretinoin has also been implemented.
All pregnancy exposures to isotretinoin must be reported immediately to the FDA via MedWatch pregnancy exposures must also be reported to the iPLEDGE pregnancy registry, either by phone or through the iPLEDGE Web site (http://www.ipledgeprogram.com).

In summation to approving the iPLEDGE syllabus, the FDA has approved changes to the existing warnings, case accusation, and informed consent papers so that patients and prescribers can wagerer identify and manage the risks of psychiatric symptoms and Great Depression before and after prescribing isotretinoin

FDA Announces Strengthened Risk Governing body System of rules to Enhance Safe Use of Isotretinoin (Accutane) for Treating Severe Acne.

This is a part of article FDA Approval Report. Taken from "Isotretinoin Accutane Side Effects" Information Blog