Roche psoriasis drug to include depression warning
Thu May 08, 2003 03:28 PM ET
NEW YORK, May 8 (Reuters) - Roche Holding AG ROCZg.VX said on Thursday its psoriasis drug, Soriatane, may cause depression, aggressive feelings and thoughts of self-harm, and has therefore added a new warning to the drug's label.
The drug, which has been on the market for six years, is a retinoid. That puts it in the same class as acne drug Accutane, the label for which warns of possible depression, psychosis and even suicide.
Roche spokeswoman Gail Safian said there have been "very few" cases of psychotic episodes in people taking Soriatane.
The label change follows discussions with the U.S. Food and Drug Administration. The label now also includes data about the drug's clinical efficacy.
There have been no clinical trials to prove that either Accutane nor Soriatane cause depression. Safian said both severe psoriasis, a condition that causes raised, scaly and inflamed patches on the skin, and severe acne are debilitating and scarring conditions that by themselves can cause depression.
Soriatane, like Accutane, can also cause serious birth defects, and is prescribed only for severe forms of the disease. Roche already has a prominent warning on its label about birth defects. Now it has strengthened that warning, and has told doctors that patients must present two negative pregnancy tests before prescribing the drug.
Psoriasis is sometimes treated with phototherapy, or ultraviolet light. The company made clearer to doctors that they should reduce the dose of ultraviolet light if using it as a treatment together with Soriatane. Retinoids make the skin more sensitive to light and therefore more sensitive to burning.
The news was released out of the Swiss drug maker's U.S. prescription drug unit, based in Nutley, New Jersey. |
