Active Ingredients: Isotretinoin
Availability: Available The availability of the drug isotretinoin at online pharmacies.
Cases of birth defects showed up in the first year, leading the FDA to begin publishing case reports and to Roche sending warning letters to doctors and placing warning stickers on drug bottles, and including stronger warnings on the label.
Lawsuits against Roche started to be filed. In 1983 the FDA's advisory committee was convened and recommended stronger measures, which the FDA took and were that time unprecedented: warning blood banks not to accept blood from people taking the drug, and adding a warning to the label advising women to start taking contraceptives a month before starting the drug.
However use of the drug continued to grow, as did the number of babies born with birth defects. In 1985 the label was updated to include a boxed warning.
In early 1988 the FDA called for another advisory committee, and FDA employees prepared an internal memo estimating that around 1,000 babies had been born with birth defects due to isotretinoin, that up to around 1,000 miscarriages had been caused, and that between 5,000 and 7,000 women had had abortions due to isotretinoin.
The memo was leaked to the New York Times a few days before the meeting, leading to a storm of media attention.
In the committee meeting, dermatologists and Roche each argued to keep the drug on the market but to increase education efforts; pediatricians and the CDC argued to withdraw the drug from the market. The committee recommended to restrict physicians who could prescribe the drug and to require a second opinion before it could be prescribed.
Roche implemented those measures, and offered to pay for contraception counseling and pregnancy testing for women prescribed the drug; the program was called the "Pregnancy Prevention Program".
A CDC report published in showed problems with the Pregnancy Prevention Program and showed that the increase in prescriptions was from off-label use, and prompted Roche to revamp its program, renaming it the "Targeted Pregnancy Prevention Program" and adding label changes like requirements for two pregnancy tests, two kinds of contraception, and for doctors to provide pharmacists with prescriptions directly; providing additional educational materials, and providing free pregnancy tests.
And Accutane, while not at the root of a nationwide opioid epidemic or vilified by pro-life extremists, is arguably the most controversial medication prescribed today by dermatologists in the U.
For many patients, Accutane seems like an oral atomic bomb, evoking images of deformed babies and horrific suicides. But for dermatology providers, Accutane occupies an almost sacred status, the gold standard for patients with recalcitrant acne, folliculitis, and a few other skin disorders that fail to respond to first-line treatments like antibiotics and retinoids.
I should know: I am one such patient.