From now on doctors and patients to will have to register in an electronic database before the drug can be dispensed. Female patients of childbearing age must take two pregnancy tests and use two forms of birth control to get the drug. And doctors and pharmacists must confirm that the requirements have been met. FDA is hoping that the new rules will reduce a large number of miscarriages, birth defects and abortions that seem to be the drug’s side effect.
There have been similar efforts by the agency to reduce harm this drug may cause but they continued to allow its continued use. In some cases, they asked for the withdrawal because physicians and pharmacists failed to control its use. The problem with withdrawal is that it would leave many patients who contended that they needed those drugs to lead normal lives.
Accutane was first approved back in 1982 for patients suffering from severe, disfiguring acne. The first reported birth defect occurred in 1983. The agency asked for pharmacists to affix warning stickers on bottles describing its effects on fetuses but the number of birth defects did not decrease.
Some reports say that the drug may cause some patients to become suicidal.