March 28,2007: FDA Launches Web Page Warning Against Online Purchase of Accutane
The U.S. Food and Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use. This New FDA Web Page warns that the drug "should only be taken under the close supervision" of a physician or a pharmacist, and provides links to helpful information, including ways to check that drugs purchased online come from legitimate pharmacies.

December 30, 2005: National Accutane Registry Begins Taking Names
A national registry of Accutane users began accepting names on December 30, 2005. The "iPLEDGE" program, intended to keep track of persons currently using the anti-acne drug, requires health care providers and pharmacists to identify all patients who have been prescribed and/or sold Accutane, or any generic version of the drug (isotretinoin). The goal of the registry is to reduce the incidence of pregnancy-related harm caused by the drug, including birth defects and birth injuries. Go here for more information about the iPLEDGE program.

August 12, 2005: FDA Announces Accutane Registry Program
The U.S. Food and Drug Administration (FDA) approved a new distribution program for Accutane, meant to prevent use of the drug by pregnant women. Under the program (called iPLEDGE) doctors, pharmacists, and patients must enroll in a national registry and accept certain responsibilities before they may prescribe or use Accutane. Patients must also complete an "informed consent" form and agree to undergo counseling on safe use of Accutane, especially as to risks related to pregnancy. Go here to read the FDA's Public Health Advisory on Accutane and iPLEDGE.

March 1, 2004: FDA Considers Registry for Accutane Users
The U.S. Food and Drug Administration (FDA) asked its scientific advisers to examine the need for further safeguards surrounding Accutane use and potential birth defects. In order to help prevent pregnancy in women using the acne drug, one proposal would allow Accutane prescriptions only for those patients whose use is tracked on a national registry. Proof of a negative pregnancy test would be required in order for any woman on the registry to receive a monthly prescription, and only doctors and pharmacists enrolled on the registry would be authorized to prescribe and disperse the drug.

February 26, 2004: Consumer Group Tells FDA to Pull Accutane
The non-profit group Public Citizen told the FDA that, due to serious risks of birth defects and links to depression, the acne drug Accutane should be pulled from the marketplace and be prescribed only under extremely limited circumstances. Before an FDA advisory committee, a Public Citizen spokesman estimated that Accutane is prescribed to women at a rate 26 times that which would be acceptable. Public Citizen is expected to again officially petition the FDA for the drug's withdrawal, as it did in 1988. Go here to read Public Citizen's testimony before the FDA advisory committee.

October 9, 2003: California Parents of Suicide Victim Sue Accutane Maker
The parents of a 14-year-old northern California boy sued Hoffman-LaRoche, the maker of Accutane, after the high school freshman threw himself in front of a train. In a state court lawsuit alleging general negligence, fraud, and medical malpractice, the parents claim that use of the prescription acne drug led to the boy's depressive behavior and eventual suicide.

September 9, 2003: FDA Warns of Illegal Foreign Versions of Accutane
The FDA sent formal warnings to a number of drug companies that had been marketing an unapproved and mislabeled foreign version of Accutane, mostly over the internet. In letters to the importers, the FDA cited the potential for serious health risks for those who could use the illegal versions of the acne drug (isotretinoin), and reiterated the dangers of purchasing prescription medication over the internet.