Active substances: Isotretinoin
Lammer, brain abnormalities are the most typical problem for Accutane babies, even babies who appear normal at birth i.
In addition, Accutane commonly inhibits the development of the bones and cartilage of the face. Heart defects, which often grow fatal, characterize the third most common problem described by Dr. The drug has become an example for academics and others proposing reform.
But none of these accounts has offered a full history of Accutane in the U. This paper takes a journalistic approach, tracing the chronology of Accutane in the U. Accutane has repeatedly pushed the frontier of FDA regulation, as the agency struggled to adapt its tools to meet the challenge of an extremely effective and extremely dangerous medication.
By emphasizing the evolving American response to the high level of risk associated with Accutane, I hope to provide the material needed to evaluate the strengths and weaknesses of our current regulatory framework.
Discovery and Pre-Market Approval: 1970-1982 Perhaps the biggest challenge in chronicling Accutane has been to decipher the early history of the drug.Over the past two decades, FDA notably birth defects. The drug causes serious side-effects, most has grappled with how manage the.
Creating a narrative has required piecing together fragments of the puzzle which surfaced over the course of the past decade. One might blame Roche: the company has repeatedly gone to court demanding that material describing the development of Accutane be kept private.
Werner Bollag first studied the chemical compound, 13-cis retinoic acid at Roche laboratories in Switzerland during the 1960 s. But Bollag also realized that the drug could cause serious birth defects.
The compound derived from vitamin A, a known teratogen. When it proved ineffective as a cancer therapy he abandoned the project.