Accutane

A detailed Summary of Accutane


Over the past twenty years, a treatment for severe acne was introduced to the world, called Accutane. The FDA approved Accutane in 1982, and since then, about five million people in the United States have been treated with it. Accutane is the only drug that has the potential to clear severe acne permanently after one course of treatment. As powerful as Accutane is with clearing up acne and improving peoples' lives emotionally and physically, it's side effects can be just as powerful. The drug is known to cause miscarriages and severe birth defects. Patients also could develop potential problems affecting organs such as liver, intestines, eyes, ears, and the skeletal system, as well as psychiatric problems, which has lead to suicide. Which is exactly what happened to BJ Stupak.

BJ Stupak was a popular seventeen years old that did not show any sign of depression, according to his parents Bart and Laurie Stupak. On the other hand his friends heard BJ talking about how his grades were not up to s


Under current law, all new drugs need proof that they work effectively and are safe. There is always some risk of an adverse reaction, but when the benefits are higher than the risks, it is considered safe enough to approve. FDA requirements include that a sponsor must submit data showing that the drug is reasonably safe for use. First they compile existing non-clinical data from laboratory or animal studies. Second they gather the data from previous testing in the United States. Next they go through new pre-clinical studies to provide proof to support the safety of administering the drug to humans. FDA requires safety updates four months after it is submitted. The decision of the FDA's approval comes down to two questions. Do the results provide evidence of effectiveness? Does the results show the drug is safe under the conditions of use in the proposed label?

Due to the concern about the drugs risks, FDA continues to evaluate Accutane and work with the manufacturer to maximize safe use of

Some common words found in the essay are:
Stupak BJ's, Accutane FDA, Roche Pharmaceuticals, Laurie Stupak, BJ Stupaks, Charles Bishop, BJ Stupak, , bj stupak, laurie stupak, severe acne, strengthened warnings, charles bishop,

Approximate Word count = 673
Approximate Pages = 3 (250 words per page double spaced)

Category: Science

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