FDA OKs Tighter Controls for Accutane
'iPLEDGE' Program Aims to Prevent Use of Acne Drug During Pregnancy
WebMD News Archive
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
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.
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.