FDA Announces New Restrictions on Acne DrugOctober 31, 2001 By Ori Twersky
WASHINGTON (Reuters Health) - Women taking Hoffmann-La Roche Inc.'s popular acne treatment Accutane (isotretinoin) will soon have to submit to new restrictions aimed at preventing unwanted pregnancies while on the drug.
The US Food and Drug Administration (FDA) said on Wednesday that it has approved significant changes to the drugmaker's pregnancy prevention program. The pregnancy prevention program was adopted about 13 years ago, when Accutane was conclusively linked to birth defects and even fetal death. But in recent years, case reports have demonstrated that some women on the drug continued to get pregnant despite these well-document side effects.
The FDA said the new restrictions will include requiring women to take a pregnancy test every month to prove that they are not pregnant as well as to sign a consent form, showing that they aware of the potential risks.
The FDA added that pharmacists would now also be restricted to dispensing a one-month supply to ensure that these restrictions are followed. The typical treatment period is about six months.
In order to make the program work, the FDA said physician wishing to prescribe the drug would receive yellow "Accutane Qualification Stickers" that must be placed on the prescription as a means of verifying the negative pregnancy test and that the patient received the appropriate counseling.
"This sticker will indicate to the pharmacists that the patient is 'qualified,'" the FDA said in a statement.
But the new restrictions are not limited to women alone. The FDA said Roche would now also be required to submit to several independent outcome measurements aimed at ensuring that the enhanced program is working.
Among these will be an independent survey by the Slone Epidemiology Unit of Boston University School of Health, and an independent audit of pharmacies to assess whether physicians are using the yellow "Accutane Qualification Stickers," the FDA said.
The FDA said these restrictions were developed in cooperation with Roche, which has previously issued several warnings as well as consumer-friendly medication guides to prevent these pregnancies.
The FDA noted that the enhanced program also followed the recommendation of expert advisors to the agency, which in September 2000 urged the company and the FDA to adopt additional controls on the distribution of the drug.
The experts' recommendations were aimed at keeping the drug on the market, while ensuring that the side effects were better managed.
According to experts, Accutane is perhaps the only effective treatment for severe acne, which can be painful and permanently disfiguring. But in recent years, the FDA noted that the number of women becoming pregnant on the drug may have actually increased rather than decreased, due to the drug's rising popularity. In a separate statement, Nutley, New Jersey-based Hoffman La Roche said that, beginning in 2002, it would be distributing a letter to physicians and patients explaining the enhanced program.
The drugmaker said the new program would be dubbed SMART (System to Manage Accutane Related Teratogenicity) and would also include the distribution of informational brochures aimed at educating physicians, patients and those pharmacists distributing the drug.
Corporate officials were not immediately available to provide further details.
SOURCE: US Food and Drug Administration (FDA)