Birth Defects and Miscarriages
Nonetheless, people kept taking Accutane, and the number of babies born with birth defects also increased. In 1985, the drug bottle’s label was updated again; three years later, another FDA advisory committee was convened, which resulted in an internal agency memo that estimated that as many as 1,000 babies had been born with birth defects, 1,000 miscarriages had been caused, and as many as 7,000 women had to receive abortions, all due to isotretinoin. The memo was leaked to The New York Times, which swung the pendulum of popular opinion against Accutane and Hoffman-La Roche.
Within the FDA, dermatologists and La Roche representatives argued in favor of keeping the drug in production and on the market but increasing educational outreach about the risks of consumption. Pediatricians and the Centers for Disease Control called for the FDA to pull Accutane off pharmacy shelves. The FDA committee eventually decided to limit the number of physicians who were in a position to prescribe the drug and required a second medical opinion before Accutane could be prescribed.
The FDA itself claimed that it did not have the legal authority to restrict who had the right to prescribe Accutane but took another unprecedented stop: It told La Roche to make their warnings even more visible and graphic, to create informed consent forms that had to be used when doctors prescribed the drug, and to conduct follow-up studies to determine whether these measures were successful in ensuring that pregnant women were no longer subject to the drug.
La Roche implemented the measures, even offering to pay for contraception counseling and pregnancy testing for women who were prescribed Accutane, but a 2000 report from the CDC found problems with La Roche’s plan. The report also found that off-label use of Accutane led to an increase in the number of prescriptions, which caused La Roche to revamp its efforts, requiring two pregnancy tests, two kinds of contraception, requiring doctors to send prescriptions to pharmacies directly, increasing the number of educational resources, and providing free pregnancy tests.
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