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FDA OKs Tighter Controls for Accutane

'iPLEDGE' Program Aims to Prevent Use of Acne Drug During Pregnancy

Close Monitoring

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 Mylan/Bertek.
  • 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 failed to show a link between the drug to severe depression or suicide.

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 release.

"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 responsibilities.

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 (866) 495-0654.

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."

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