Kentucky Accutane Lawyer

Accutane is the trade name under which the pharmaceutical company Hoffman-LaRoche marketed the prescription acne medication Isotretinoin from 1982 through 2009. While Accutane has proven extremely effective as a treatment for severe disfiguring acne, it has been linked to a huge array of adverse reactions – one of the three highest numbers of negative side effects for any drug on record.

Accutane Warning Labels

When Accutane was initially approved in 1982, the Food and Drug Administration insisted upon package labeling cautioning that the medication ought only to be used in cases of "severe, disfiguring nodular acne that is recalcitrant to standard therapies."

Unfortunately many dermatologists chose to interpret that package warning so liberally that Accutane was often prescribed as the first line of attack for acne outbreaks, without any attempt to treat the outbreak through more conservative means like topical and oral antibiotics.

Between 1989 and 1999, the number of Accutane prescriptions written in the U.S. rose by 300 percent, from 70,000 per year to 210,000. The drug was marketed directly to teenagers despite evidence that it stopped long bone growth in the target group.

Accutane Side Effects

Accutane has been linked to miscarriages and severe birth defects when taken during pregnancy. Adverse reactions also include neurological problems; gastrointestinal issues (severe pain, nausea and vomiting, ulcerative colitis, Crohn’s disease and inflammatory bowel disorder); sensory impairment (hearing and vision loss); decreased bone density; immunodeficiency; and severe depression including suicidal ideation. A 2006 study found that as many as 40 percent of all Accutane users showed a rise triglyceride blood levels and as many as one in three users exhibited elevated cholesterol levels.

Accutane Risk Management

In 1998, the FDA required Roche to include stronger language in its labels specifically mentioning Accutane’s links to psychiatric disease. The following year, Roche began a pregnancy prevention targeted at women of reproductive age considering Accutane as an acne treatment. This included labeling and prescription protocol changes, Continuing Education classes for prescribing physicians and the distribution of a video explaining the risks for physicians to show prospective patients. In 2001 and again in 2006, the FDA instituted its own risk management programs.

But these interventions are clearly insufficient for a predominantly teenage population. Roche and physicians who prescribed Accutane may claim they were diligent in educating their patients about the medication’s risks and performing follow-up, but the huge volume of complaints among users argues otherwise.

Accutane Litigation in these Cities and Others:

Louisville
Lexington
Owensboro
Bowling Green
Covington
Richmond
Hopkinsville
Henderson
Frankfort
Florence