FDA OKs Tighter Controls for Accutane
'iPLEDGE' Program Aims to Prevent Use of Acne Drug During Pregnancy
WebMD News Archive
The drug companies behind iPLEDGE have pledged to watch the system closely.
Pharmacies that don't comply could be cut off from receiving the drug, and the
drug's Internet availability will also be monitored, says Kweder.
All four companies making the drug -- plus one distributor -- are involved
in iPLEDGE, says Kweder. Those companies include:
- Roche, manufacturer of Accutane.
- Genpharm, manufacturer of Amnesteem, which is distributed by
- Ranbaxy Pharmaceuticals, manufacturer of Sotret.
- Barr Laboratories, manufacturer of Claravis.
Any companies that start making other generic versions of the drug must join
iPLEDGE, says Kweder.
Changes to Drug's Psychiatric Notes
Accutane and generic versions of the drug may cause depression, psychosis,
and, rarely, suicidal thinking, suicide attempts, suicide, and aggressive
and/or violent behaviors. However a small study earlier this year
The FDA has approved changes to the drug's existing warnings, patient
information, and informed consent. The goal is to help patients and prescribers
"better identify and manage the risks of psychiatric symptoms and
depression before or after prescribing isotretinoin," states the FDA's news
"The specific intent of the iPLEDGE program is to prevent pregnancy, but
this is a drug that has a number of potential side effects including the
concern about psychiatric effects, but others as well. The intent is that
patients be educated about all of the potential risks as part of their
participation in taking the medicine," says Kweder.
To Register for iPLEDGE
Starting on Aug. 22, doctors, patients, and pharmacies can get program
information and register with iPLEDGE online at www.ipledgeprogram.com or by
telephone ((866) 495-0654).
Starting Nov. 1, wholesalers and pharmacies will have to register with
iPLEDGE to obtain isotretinoin from a manufacturer.
By Dec. 31, all patients and prescribers (doctors) must register and comply
with requirements for office visits, counseling, birth control, and other
FDA: Report All Pregnancy Exposures to Drug
A reporting and collection system for serious side effects associated with
isotretinoin has also been implemented.
All pregnancy exposures to isotretinoin must be reported immediately to the
FDA's MedWatch system ((800) FDA-1088) and to iPLEDGE online or by phone at
Statement From Roche
In a statement emailed to WebMD, the drug company Roche states that it is
"pleased" with iPLEDGE's approval and pledges to keep working with the
FDA and "support ongoing efforts to prevent, to the extent possible, the
risk of fetal exposure to isotretinoin."