The drug previously considered an effective treatment for acne is now being scrutinized for not only causing severe birth defects, but also psychotic side effects and suicidal tendencies.

Accutane, primarily used for severe cases of nodular or cystic acne that doesn’t respond to other treatments, has been known to increase the risks of birth defects since it was initially marketed, according to its manufacturers, Hoffman-La Roche.

Roche has recently begun efforts to counter the risk of premature births, miscarriages and internal and external abnormalities in the fetus, by creating a program to ensure women aren’t pregnant and do not become pregnant while being treated with Accutane.

The program, System to Manage Accutane-Related Teratogenicity (SMART), will require female patients to have two negative pregnancy tests and commit to using two forms of birth control — starting one month before treatment through one month after stopping; they must read and sign a consent agreement explaining the risk of birth defects associated with the drug; and have a negative pregnancy test and contraception counseling from the prescribing physician before getting a new prescription. Yellow “qualification” stickers will be placed on the prescription, upon compliance — prescriptions will not be filled without stickers.

Despite taking steps toward educating these patients, Roche has failed to address the side affects of Accutane associated with depression, psychotic behavior, and suicidal tendencies — exemplified by Charles Bishop, who had been prescribed Accutane and killed himself by flying a single engine plane into the 42-story Bank of America building in Tampa, FL, last year.

Bishop’s mother has filed a $70 million wrongful death and negligence lawsuit against Hoffman-La Roche, contending that Accutane is an unsafe drug and its manufacturers failed to adequately warn the public of a potential link to depression and suicide.

SOURCE: The ChiroPediatric Times, Summer 2002, p. 19.