You are here: Home pathway Area of law pathway Soriatane

Defective Drugs Lawyers and Attorneys Legal Help

Soriatane

Soriatane, also known as acitretin, is associated with a class of medications known as retinoids and is indicated for the treatment of severe psoriasis, a debilitating skin disorder. Individuals diagnosed with psoriasis suffer from inflamed, red, scaly lesions, caused when affected skin cells reproduce quicker than usual. Soriatane allows skin to develop and multiply normally by targeting receptors in skin cells. The medication, which comes in capsule form to be taken orally one time a day, controls psoriasis but does not cure the disorder. Made by Roche, Soriatane was approved by the U.S. FDA in 1997.

Side effects of Soriatane use consist of, but may not be limited to, headache, nausea, joint and muscle pain, dry, irritated eyes, a runny or bloody nose, peeling, tingling skin, stomach pain, diarrhea, thinning of the hair and eyebrows, and mouth irritation.

A black box warning on Soriatane's label specifies that woman who are pregnant or intend to become pregnant within three years of stopping treatment must not use the medication. Soriatane has been connected with an increased risk of birth defects. It is suggested that women use two or more reliable birth control treatments one month prior to treatment, during treatment and for at least three years after discontinuing treatment. The medication should be prescribed only after two negative pregnancy tests. If Soriatane is used with alcohol, a toxic compound may form which can also harm the fetus. Soriatane has been linked to liver damage and intercranial hypertension (pressure in the skull).

In May 2003, Roche added a warning to Soriatane's label, warning users of the drug's link to depression, aggressive feelings and moods of self-harm. The new label is similar to that of Accutane, another retinoid that has been linked to depression.