Accutane: From Laudation to Lawsuit

It has been said that Accutane has the ability to clear and prevent acne more effectively than any other medication introduced to the market. Despite this fact, many now say that Accutane should never have been offered as a treatment for blemishes, since its slew of serious side effects clearly outweigh any benefits to the complexion. Accutane has been proven to severely damage the digestive tract and to cause birth defects in the unborn children of pregnant consumers. Faced with hundreds of lawsuits from patients who suffered these side effects, Roche (the manufacturer) finally issued an Accutane recall.

Accutane: The Good, The Bad

Accutane falls into the category of retinoids, indicating a derivative of vitamin A. Its skin-clearing ability is due to its effect of greatly reducing oil production in the skin’s sebaceous glands and other areas. Accutane, also known by its generic moniker Isotretinoin, passed muster with the FDA in 1982. From the beginning, it proved to be amazingly effective at treating and preventing acne, and it enjoyed an unprecedented 85 percent success rate. Numerous reports and praise calling Accutane a ‘miracle drug’ ensued. The man said to be responsible for its discovery, Dr. Gary Peck, received several acclaimed awards for his work.

Following close on the heels of praise and profits (to the tune of hundreds of millions of dollars each year) were disturbing reports of “teratogenic” side effects, or side effects that cause malformation in embryos. Close to 30 percent of all pregnant women taking Accutane witnessed their babies born with birth defects as a result. Even more disturbing was the fact that many doctors were not performing adequate pregnancy tests before prescribing the drug to women.

Reducing Accutane Birth Defects

In order to fight the nightmare of Accutane birth defects, the FDA decided to create a program named iPLEDGE in 2006. This program spelled out regulations that required not one but two consecutive negative pregnancy tests for any female patient wanting a prescription for Accutane. In addition, women were obliged to promise that they would use two forms of birth control before they were allowed to begin taking the drug.

Other Accutane Side Effects Appear

There was no program or list of guidelines the FDA could come up with that could prevent the other side effects that resulted from taking Accutane. It was discovered that the quantities of the drug frequently prescribed by doctors were sufficient to alter the delicate chemical balance of the digestive system. In particular, a direct link between Accutane and gastrointestinal disorders such as inflammatory bowel disease (IBM), Crohn’s disease, and Accutane ulcerative colitis was proven by several studies. All of these conditions can lead to colon removal, which of course has a permanent detrimental effect on quality of life.

Accutane Recall

Ultimately, after selling more than 13 million prescriptions, drugmaker Roche initiated an Accutane recall and retired the drug from the market. According to the manufacturer, this action was due to economic reasons, which may be due fully or in part to the hundreds of Accutane side effect lawsuits that have been filed against them.