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FDA OKs Tighter Controls for Accutane

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

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Doctors, Patients, Pharmacies Must Register

Doctors, pharmacies, and wholesalers must also register with iPLEDGE and take on certain duties.

For instance, the prescribing doctor must counsel patients about the drug's risks, give them an informed consent form, register with iPLEDGE, note patients taking the drug in the iPLEDGE system, and receive patients' pregnancy test results.

Pharmacies must log on to iPLEDGE and check that everything is in order before filling a prescription for the drug for women of childbearing age.

Wholesale companies must agree only to give the drug to pharmacies that register with iPLEDGE.

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.