Originally manufactured and sold by Hoffman-La Roche, Accutane is best known for its use in treating cystic acne. Acne is something that many people look back on with dread, and it can cause great psychological distress in a teenager, but sometimes the treatment is worse than the condition, and that is often the case with isotretinoin (the drug’s trade name). Isotretinoin is not like the over the counter topical agents or face scrubs that people are most familiar with when treating acne. It is a powerful substance that was originally designed to prevent some skin cancers. However, Hoffman-La Roche soon noticed its ability to ameliorate some forms of acne.
WHAT WENT WRONG WITH ACCUTANE?
Isotretinoin has been around for a long time, and in 1971, researchers testing it for use in cancer determined it was much more effective in improving acne. These observations were corroborated by several other research groups in the years following, and in 1982, the FDA approved it for use. Its path to approval in Europe was much tougher, as doctors there were worried about its propensity to cause birth defects.
That was also a fear in the U.S., as isotretinoin is a known teratogen. This means that it has a demonstrable and deleterious effect on a fetus, causing severe and permanent birth defects. In isotretinoin’s case, birth defects can include profoundly malformed ears, head or face, along with impaired vision or hearing, or mental retardation. It has also been linked to more than 1,000 miscarriages and several thousand terminations due to severe fetal abnormalities. These birth defects can appear even with extremely short-term use of the drug during pregnancy. In response to these fears, the FDA took unprecedented steps in curbing its prescription in pregnant women, even regulating blood donations and placing the dreaded “black box” label on its packaging.
This wasn’t enough, though, as half of prescribing doctors failed to test women for pregnancy before giving the medication out, needlessly exposing thousands of unborn children to the drug. The FDA created the iPLEDGE program in 2005 to register and qualify women before taking Accutane.
While the iPLEDGE system worked, other side effects with isotretinoin started gaining awareness. In particular, its role in inflammatory bowel disease and ulcerative colitis was gaining notice. Both conditions can result in debilitating digestive issues, causing pain, constant diarrhea, persistent nausea, and other unpleasant effects. Several lawsuits, including a $25 million judgment, have asserted that isotretinoin caused their inflammatory bowel disease or ulcerative colitis, and in many cases these lawsuits confirmed their assertion. Higher rates of depression, suicidal ideation and suicidal tendencies have also been noted by researchers, and at least 13 people have committed suicide after ceasing use of the drug.
Houston Accutane Attorney
With so many fears regarding Accutane, Hoffman-La Roche ceased production of the medication in 2009, though it still sells it outside of America. Still, there are many people who are preparing for their day in court, as Accutane continues to produce side effects in many who have been prescribed it, or a generic version of the drug. With several claims already decided on, there is a foundation for these claims, and experienced drug injury lawyers can use them to assist their own clients.